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EC number: 202-446-3 | CAS number: 95-74-9
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No OECD guideline or GLP defined.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 979
Materials and methods
- Principles of method if other than guideline:
- In a sensitization test 10 hair-clipped healthy female Hartley guinea pigs weighing 400 -500 g each were used. A modified Buehler and Griffith (1975) method was used (modifications included 24 -hour, instead of 6 -hour, occlusion of the first inductive application). A total of 3 inductive applications were performed on the backs of the animals at the rate of 1 application per week. Challenge doses were applied 2 and 3 weeks after the last inductive application. 50 mg of each compound (0.5 cc) was applied with a 1 cc syringe and the animals were immobilized on a restraining board for 6 hours. The first inductive and the challenge application remained under occlusion for 24 hours; the second and third induction for 6 hours. 24 hours after each application, the sites were scored for erythema based on a 0 (no erythema) to 4 (severe erythema) scale according Draize.
- GLP compliance:
- not specified
- Type of study:
- other: modified method by Buehler and Griffith
- Justification for non-LLNA method:
- Data were published in the year 1979.
Test material
- Reference substance name:
- 3-chloro-p-toluidine
- EC Number:
- 202-446-3
- EC Name:
- 3-chloro-p-toluidine
- Cas Number:
- 95-74-9
- Molecular formula:
- C7H8ClN
- IUPAC Name:
- 3-chloro-4-methylaniline
- Details on test material:
- IUCLID4 Test substance: other TS: it is not specified if 3-chloro-p-toluidine was used as free base or as hydrochloride
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: distilled water
- Concentration / amount:
- 10% solution in distilled water. 50 mg of test substance (0.5 cc) was applied.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: distilled water
- Concentration / amount:
- 10% solution in distilled water. 50 mg of test substance (0.5 cc) was applied.
- No. of animals per dose:
- 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 mg
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- slight erythema (score of 1)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 mg. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: slight erythema (score of 1).
- Reading:
- 2nd reading
- Group:
- test chemical
- Dose level:
- 50 mg
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- 2 well-defined erythema (score of 2), and 8 slight erythema (score of 1).
- Remarks on result:
- other: Reading: 2nd reading. Group: test group. Dose level: 50 mg. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: 2 well-defined erythema (score of 2), and 8 slight erythema (score of 1)..
- Group:
- positive control
- Remarks on result:
- other: no data reported
- Group:
- negative control
- Remarks on result:
- other: no data reported
Any other information on results incl. tables
No irritation due to treatment was observed during the inductive period with the test substance. 24 hours after the first challange, 6 of 10 animals responded with slight erythema (score of 1). After the second challenge application of the test substance, all animals had some reaction: 2 well-defined erythema (score of 2), and 8 slight erythema (score of 1).
50 mg of the substance as a 10 % aqueous solution was applied to the back of each of 10 female guinea pigs; the test was conducted according to the following scheme:
induction exposure: initial exposure for 24 hours under occlusion, a secondary exposure for 6 hours after one week, another exposure of 6 hours during the third week; challenge exposure: first challenge application with 24 hours of exposure under occlusion occurring 2 weeks after the last inductive treatment, a renewed application 1 week later; the treated sites were examined 24 hours after each application
Effects: no irritation due to treatment was observed during the inductive period; 24 hours after the first challenge application, 6 of the 10 animals responded with slight erythema; after the second challenge exposure, all 10 animals had some reaction: 2 well-defined erythema and 8 slight erythema
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Executive summary:
In a sensitization test 10 hair-clipped healthy female Hartley guinea pigs weighing 400 -500 g each were used. A modified Buehler and Griffith (1975) method was used (modifications included 24 -hour, instead of 6 -hour, occlusion of the first inductive application). A total of 3 inductive applications were performed on the backs of the animals at the rate of 1 applikation per week. Challange doses were applied 2 and 3 weeks after the last inductive application. 50 mg of each compound (0.5 cc) was applied with a 1 cc syringe and the animals were immobilized on a restraining board for 6 hours. The first inductive and the challange application remained under occlusion for 24 hours; the second and third induction for 6 hours. 24 hours after each application, the sites were scored for erythema an a 0 (no erythema) to 4 (severe erythema) scale according Draize (1944).
No irritation due to treatment was observed during the inductive period with the test substance. 24 hours after the first challange, 6 of 10 animals responded with slight erythema (score of 1). After the second challenge application of the test substance, all animals had some reaction: 2 well-defined erythema (score of 2), and 8 slight erythema (score of 1). Due to this result the test substance was found to be sensitizing in guinea pigs.
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