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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-07-18 to 1989-08-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Cited as Directive 84/449/EEC, B.6
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 2-chloroaniline
- EC Number:
- 202-426-4
- EC Name:
- 2-chloroaniline
- Cas Number:
- 95-51-2
- Molecular formula:
- C6H6ClN
- IUPAC Name:
- 2-chloroaniline
- Details on test material:
- - Name of test material (as cited in study report): o-Chloraniline
- Physical state: yellow-orange, clear liquid
- Analytical purity: 99.6 % (IR spectroscopy)
- Impurities (identity and concentrations):
<0.01 % cyclohexylamine
<0.01 % N-isopropylaniline
<0.01 % 2-chloro-N-isopropylaniline
0.08% aniline
<0.01% 2-isopropylaniline
<0.01% o-nitrochlorobenzene
0.24% p-chloroaniline
<0.01% m-chloroaniline
<0.01% 2,4-dichloroaniline
<0.01% 2,5-dichloroaniline
<0.01% 2,3-dichloroaniline
<0.01% 2,3-dichloroaniline
<0.01% o-phenylendiamine
0.03 % unknown impurities
- Purity test date: 1 Feb 1988
- Lot/batch No.: Lagerkessel 15/ 594 488
- Stability under test conditions: stable and homogen throughout the test period
- Storage condition of test material: 3-7°C, dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Bor:DHPW
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 310-395 g
- Housing: 5 animals per Macrolon cage type IV on wood chips (Ssniff), cleaned 4 times a week
- Diet: ad libitum, Altromin 3020
- Water: ad libitum, tap water
- Acclimation period: 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): ~50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- intradermal induction: 5 % (w/v)
epicutaneous induction: 100 %
epicutaneous challenge: 100 %
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- intradermal induction: 5 % (w/v)
epicutaneous induction: 100 %
epicutaneous challenge: 100 %
- No. of animals per dose:
- test group: 20 male randomized guinea pigs
control group 1: 10 male randomized guinea pigs
control group 2: 10 male randomized guinea pigs - Details on study design:
- RANGE FINDING TESTS:
intradermal: 1-5 % o-chloroaniline (w/v), injection site showed slight irritation after 48 h
epicutaneous: yes, no irritation was observed at any concentration (12, 25, 50 and 100 % (w/v) tested after 24 h
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: day 0 intradermal induction
day 7 epicutaneous induction for 48 h
- Control groups:
day 0: 1st injection, cranial, 0.1 mL, FCA : 0.9 % saline solution= 1 : 1
2nd injection, medial, 0.1 mL, propylene glycol
3rd injection, caudal, 0.1 mL, FCA : propylene glycol (w/v)= 1 : 1
day 6: epicutaneous treatment of the same areas with 0.2 mL 10 % SDS in paraffine oil
day 7: 3 occlusive gauze patches (2 x 4 cm)
- Test group:
day 0: 1st injection, cranial, 0.1 mL, FCA : 0.9 % saline solution= 1 : 1
2nd injection, medial, 0.1 mL, 5 % o-chloroaniline in propylene glycol (w/v)
3rd injection, caudal, 0.1 mL, FCA : 5 % o-chloroaniline in propylene glycol (w/v)= 1 : 1
day 6: epicutaneous treatment of the same areas with 0.2 mL 10 % SDS in paraffine oil
day 7: 3 occlusive gauze patches (2 x 4 cm) treated with 0.5 mL 100 % o-chloroaniline
B. CHALLENGE EXPOSURE
- No. of exposures: 3 ( epicutaneous)
- Day(s) of challenge: 3 weeks after intradermal induction
- Exposure period: 24 h
- Test groups:
challenge: 21st day, 1 semiocclusive gauze patch (2 x 4 cm) at the left flank treated
with 0.5 mL 100 % o-chloroaniline
- Control group:
1st control group: 21st day, 1 occlusive gauze patch (2 x 4 cm) at the left flank treated
with 0.5 mL 100 % o-dichloroaniline
- Site: left flank challenge, right flank control (gauze patch)
- Evaluation (hr after challenge): 48 and 72 h after challenge according to OECD guideline 406 - Challenge controls:
- yes
- Positive control substance(s):
- not required
Results and discussion
- Positive control results:
- no
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 % . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Any other information on results incl. tables
No influence on body weight gain was observed. After challenge skin sensitisation was observed neither in the control nor in the test group.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Classification: not sensitizing
- Executive summary:
Diesing, L, 1990
o-Chloroaniline was tested for skin sensitisation according to OECD guideline 406 in a Magnusson and Kligman test in male guinea pigs. No irritation was evident in the control group and test group after challenge with 100 % o-chloroaniline. Therefore o-chloroaniline was categorised as not sensitising.
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