Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-426-4 | CAS number: 95-51-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Although the o-isomer of the chloroanilines exhibits genetic toxicity the profile of activity is inconsistent. It was not mutagenic in S. typhimurium, but induced gene mutations in mouse lymphoma cells. o-Chloroaniline was positive for induction of micronuclei in rat, but not in mouse, bone marrow cells. It was also not mutagenic in peripheral blood cells of mice of a 13 week gavage study (NTP report Tox 43). o-Chloroaniline has not been evaluated for potential carcinogenicity in laboratory animals, yet. The toxicity data for o-chloroaniline suggest that if progression of erythrocyte toxicity leads to the formation of splenic lesions in rats, then o-chloroaniline would likely be positive in the rodent carcinogen bioassay. However, if carcinogenicity is dependent on genotoxicity, then the o-chloroaniline which displays if any only weak genotoxic activity, may not be carcinogenic in a rodent bioassay. It is therefore difficult to predict carcinogenic activity of o-chloroaniline based on the available information. Due to the fact that o-chloroaniline is solely used under strictly controlled conditions in a closed system and exposure is only expected in case of accidental release, further studies leading to classification or non-classification as carcinogenic do not seem necessary.
Short description of key information:
1. o-Chloroaniline ( 3.3, 10, 33, 100, 333, 1000 and 3333 µg/plate) was tested for genotoxicity in a bacterial reverse mutation assay with Salmonella typhimurium TA97, TA98, TA100 and TA 1535 with and without metabolic activation with either Aroclor 1254 induced male Syrian hamster liver S9-mix or male Sprague Dawley rat liver S9-mix (10 and 30 %) equivalent to OECD471. The obtained results were negative in all strains tested, whereas the positive and negative controls acted as expected and were therefore valid (Zeiger, E, (1987)).
2. o-Chloroaniline was tested for mutagenicity in an in vitro mammalian cell gene mutation assay with L5178Y (TK+/TK-) mouse lymphoma cells equivalent to OECD476. Revertant colonies are deficient in thymidine kinase due to the mutation of TK+/TK- to TK-/TK- and will therefore be resistant to the cytotoxic effects of trifluorothymidine. o-Chloroaniline induced significant increases in trifluorothymidine mutations in L5178Y mouse lymphoma cells with S9 activation enzymes. The lowest effective dose that produced a mutagenic response was 300 µg/mL. o-Chloroaniline produced a significant increase in mutant colonies only at the highest concentration tested (400 µg/mL) in the second trial performed without S9 mix; results of the first trial without S9 mix were considered to be inconclusive, because although no increase in mutant colonies was observed, the relative total growth (33%) observed at the highest dose indicated that higher concentrations of o-chloroaniline could have been tested (McGregor, DB et al. (1991)).
3. o-Chloroaniline was tested for its ability to induce unschedulded DNA-synthesis in primary rat hepatocytes equivalent to EU method B.18. The results do not indicate an increase of DNA- repair synthesis at non-cytotoxic doses of o-chloroaniline (Yoshimi, N et al., (1988)).
4. o-Chloroaniline was orally administed (gavage) to NMRI mice at a concentration of 500, 1000 or 1500 mg/kg body weight in polyethylene glycol and the clas...
Endpoint Conclusion:
Justification for classification or non-classification
Various substances structurally related to aniline have been proven to be mutagenic. o-Chloroaniline itself was tested positiv for mutagenicity in an in vitro mammalian cell gene mutation assay with L5178Y (TK+/TK-) mouse lymphoma cells equivalent to OECD476 and showed a weakly clastogenic effect on polychromatic erythrocytes of the bone marrow (femur) when orally administered to NMRI mice at a concentration of 500, 1000 or 1500 mg/kg body weight (EU method B.12). Therefore it is suggested to classify o-chloroaniline as Category 3 (DSD-DPD) and Category 2 (GHS) Mutagen.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.