Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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
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.
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.
