•2-Ethylbutyric acid; a safety assessment based on RIFM's criteria.•A safety assessment based on 7 human health endpoints plus environmental.•All endpoints were cleared using target data, read-across, and/or TTC.
• p -Tolyl alcohol; a safety assessment based on RIFM's criteria. • A safety assessment based on 7 human health endpoints plus environmental. • All endpoints were cleared using target data, read-across, and/or TTC.
• dl- Limonene (racemic); a safety assessment based on RIFM's criteria. • A safety assessment based on 7 human health endpoints plus environmental. • All endpoints were cleared using target data, read-across, and/or TTC.
• Cinnamyl acetate; a safety assessment based on RIFM's criteria. • A safety assessment based on 7 human health endpoints plus environmental. • All endpoints were cleared using target data, read-across, and/or TTC.
• Octahydro-8,8-dimethylnaphthalene-2-carbaldehyde; a safety assessment based on RIFM's criteria. • A safety assessment based on 7 human health endpoints plus environmental. • All endpoints were cleared using target data, read-across, and/or TTC.
The existing information supports the use of this material as described in this safety assessment. 5,8-Methano-2H-1-benzopyran, 6(or 7)-ethylideneoctahydro-, [4aR,5S,8S,8aS(or 4aR,5R,8S,8aR)]-rel- was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog 5,8-methano-2H-1-benzopyran-2-one, 6- ethylideneoctahydro- (CAS # 69486-14-2) show that 5,8-methano-2H-1-benzopyran, 6(or 7)-ethylideneoctahydro-, [4aR,5S,8S,8aS(or 4aR,5R,8S,8aR)]-rel- is not expected to be genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the TTC for a Cramer Class III material, and the exposure to 5,8-methano-2H-1-benzopyran, 6(or 7)-ethylideneoctahydro-, [4aR,5S,8S,8aS(or 4aR,5R,8S,8aR)]-rel- is below the TTC (0.0015 mg/kg/day, 0.0015 mg/kg/day, and 0.47 mg/day, respectively). Data provided 5,8-methano-2H-1-benzopyran, 6(or 7)-ethylideneoctahydro-, [4aR,5S,8S,8aS(or 4aR,5R,8S,8aR)]-rel- a NESIL of 8200 μg/cm2 for the skin sensitization endpoint. The phototoxicity/photoallergenicity endpoints were evaluated based on human study data and UV/Vis spectra; 5,8-methano-2H-1-benzopyran, 6(or 7)-ethylideneoctahydro-, [4aR,5S,8S,8aS(or 4aR,5R,8S,8aR)]-rel- is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 5,8-methano-2H-1-benzopyran, 6(or 7)-ethylideneoctahydro-, [4aR,5S,8S,8aS(or 4aR,5R,8S,8aR)]-rel- was found not to be PBT as per the IFRA Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.
• 3(2H)-Furanone, 5-ethyl-4-hydroxy-2-methyl-; a safety assessment based on RIFM's criteria. • A safety assessment based on 7 human health endpoints plus environmental. • All endpoints were cleared using target data, read-across, and/or TTC.
•Cyclooct-4-en-1-yl methyl carbonate; a safety assessment based on RIFM's criteria.•A safety assessment based on 7 human health endpoints plus environmental.•All endpoints were cleared using target data, read-across, and/or TTC.
• Isoeugenyl methyl ether ; a safety assessment based on RIFM's criteria. • A safety assessment based on 7 human health endpoints plus environmental. • All endpoints were cleared using target data, read-across, and/or TTC.
• Sodium benzoate; a safety assessment based on RIFM's criteria. • A safety assessment based on 7 human health endpoints plus environmental. • All endpoints were cleared using target data, read-across, and/or TTC.
•trans-2-Nonenal; a safety assessment based on RIFM's criteria.•A safety assessment based on 7 human health endpoints plus environmental.•All endpoints were cleared using target data, read-across, and/or TTC.
In recent years, the Japanese Teratology Society has worked with the DevTox Berlin Workshops project to provide internationally consistent terminology for teratogenic effects. This paper summarizes a satellite workshop of the 60th Annual Meeting of the Japanese Teratology Society, which was entitled "Current activities between DevTox Berlin Workshops to develop a harmonized terminology for classifying anomalies in laboratory animals in developmental toxicity studies." The Japanese Teratology Society - Laboratory Animal Terminology Project (JTS-LATP) reviewed "gray zone" anomalies and focused on developing criteria for reclassifying a large number of gray zone anomalies to clarify them and to make it easier to judge fetal categories. This effort will lead to international agreement, based on shared conceptions. The present article aimed to provide the reader with a summary of the issues discussed at the 2020 satellite meeting, which included discussions on open issues from the DevTox Berlin Workshops, ongoing work by the JTS-LATP on gray zone (GZ) anomalies, current industrial concerns, and future challenges.
•Isoeugenyl ethyl ether; a safety assessment based on RIFM's criteria.•A safety assessment based on 7 human health endpoints plus environmental.•All endpoints were cleared using target data, read-across, and/or TTC.
• Methyl N-methylanthranilate; a safety assessment based on RIFM's criteria. • A safety assessment based on 7 human health endpoints plus environmental. • All endpoints were cleared using target data, read-across, and/or TTC.
•5-Methyl-2-hepten-4-one; a safety assessment based on RIFM's criteria.•A safety assessment based on 7 human health endpoints plus environmental.•All endpoints were cleared using target data, read-across, and/or TTC.
•Undecenal; a safety assessment based on RIFM's criteria.•A safety assessment based on 7 human health endpoints plus environmental.•All endpoints were cleared using target data, read-across, and/or TTC.
•Eugenol; a safety assessment based on RIFM's criteria.•A safety assessment based on 7 human health endpoints plus environmental.•All endpoints were cleared using target data, read-across, and/or TTC.
• Phenylethyl isoamyl ether; a safety assessment based on RIFM's criteria. • A safety assessment based on 7 human health endpoints plus environmental. • All endpoints were cleared using target data, read-across, and/or TTC.
•5-Cyclotetradecen-1-one, 3-methyl-, (5E)-; a safety assessment based on RIFM's criteria.•A safety assessment based on 7 human health endpoints plus environmental.•All endpoints were cleared using target data, read-across, and/or TTC.
• 2,10-Tetradecadienenitrile, (2E,10Z)-; a safety assessment based on RIFM's criteria. • A safety assessment based on 7 human health endpoints plus environmental. • All endpoints were cleared using target data, read-across, and/or TTC.