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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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: Comparable to guideline study with restrictions (Method shortly described. Analytical purity, housing and feeding conditions were not reported. Only 4 vehicle control used)
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
The local lymph node assay: results of a final inter-laboratory validation under field conditions
Author:
Scholes EW, Basketter DA, Sarll AE, Kimber I, Evans CD, Miller K, Robbins MC, Harrison PTC, Waite SJ
Year:
1992
Bibliographic source:
Journal of Applied Toxicology, 12(3):217-222.
Reference Type:
review article or handbook
Title:
4-CHLOROANILINE
Author:
IPCS-INCHEM
Year:
2003
Bibliographic source:
in: Concise International Chemical Assessment Document 48
Reference Type:
secondary source
Title:
Chlortoluidine
Author:
BUA
Year:
1990
Bibliographic source:
BUA-Report, VCH Weinheim, 1990
Reference Type:
review article or handbook
Title:
p-Chloranilin, BUA-Stoffbericht 153
Author:
BUA
Year:
1995
Bibliographic source:
Beratergremium für umweltrelevante Altstoffe (BUA) der Gesellschaft Deutscher Chemiker, S Hirzel Vorlag, Stuttgart

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Method shortly described. Analytical purity, housing and feeding conditions were not reported. Only 4 vehicle control used.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
4-chloroaniline
EC Number:
203-401-0
EC Name:
4-chloroaniline
Cas Number:
106-47-8
Molecular formula:
C6H6ClN
IUPAC Name:
4-chloroaniline
Details on test material:
- Name of test material (as cited in study report): 4-Chloroaniline
- Analytical purity: no data

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Porcellus, Heathfield, Sussex, UK
- Weight at study initiation: 300-350 g

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
no data
Concentration / amount:
Intradermal induction concentration : 0.3%
Topical induction concentration: 10%
Challenge concentration: 2.5%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
no data
Concentration / amount:
Intradermal induction concentration : 0.3%
Topical induction concentration: 10%
Challenge concentration: 2.5%
No. of animals per dose:
10 treated animals and 4 controls
Details on study design:
p-Chloroaniline was evaluated by Laboratory A using a GPMT based on that described by Magnusson and Kligman. Preliminary skin irritation studies were conducted to determine suitable concentrations of test chemical for induction and elicitation of sensitization. Test guinea pigs (n=10) were sensitized by a series of intradermal injections of a slightly irritant concentration of the test chemical in combination with Freund´s complete adjuvant (FCA) in the shoulder region. Six to eight days a mildly irritant concentration of test chemical was applied over the injection site using a 48 h occluded patch. Control guinea pigs (n=4) were treated similarly, but with vehicle alone. After 12-14 days all animals were challenged with the maximum non-irritant concentration of the test chemical on one clipped andrazoredflank using a 24-h occluded patch. The potential of a test chemical to cause skin sensitization was determined by visual assessment oferythema at the challenge sites, 24 and 48 hours after removal of challenge patches. The sensitization potential was expressed as the percentage of test guinea pigs exhibiting a reaction significantly greater than in control guinea pigs.
 
Challenge controls:
No data
Positive control substance(s):
not specified

Results and discussion

Positive control results:
no data

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: visual assessment of erythema at the challenge sites, 24 and 48 hours after removal of challenge patches
Hours after challenge:
72
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
6
Total no. in group:
10
Remarks on result:
other: Reading: other: visual assessment of erythema at the challenge sites, 24 and 48 hours after removal of challenge patches. . Hours after challenge: 72.0. Group: test group. Dose level: 2.5%. No with. + reactions: 6.0. Total no. in groups: 10.0.
Reading:
other: visual assessment of erythema at the challenge sites, 24 and 48 hours after removal of challenge patches
Hours after challenge:
72
Group:
negative control
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: other: visual assessment of erythema at the challenge sites, 24 and 48 hours after removal of challenge patches. . Hours after challenge: 72.0. Group: negative control. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 4.0.

Any other information on results incl. tables

In the GMPT, 4-Chloroaniline did not elicited positive reactions in the control guinea pigs. 4-Chloroaniline was classified as a moderate sensitizer in GPMT.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Executive summary:

Scholes (1992):

In guinea-pigs, the sensitizing potential of 4-chloroaniline in the guinea-pig maximization test according to Magnusson & Kligman (1969) [similar to OECD guideline 406 with deviations (Method shortly described. Analytical purity, housing and feeding conditions were not reported. Only 4 vehicle controls have been used).  

In the GMPT, 4-Chloroaniline did not elicited positive reactions in the control guinea pigs, but induced sensitization in 60 % of the treated animals. Therefore 4-Chloroaniline was classified as a moderate sensitizer in GPMT.