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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study according OECD 406

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Principles of method if other than guideline:
In a guinea pig maximisation test according Magnusson and Kligman 20 male animals (control: 10 male animals) per test group were used.
1. Induction: Intradermal application into the back of 0.1 ml p-Chlorotoluene; one week later:
2. Induction: topical application of a plaster containing 0.5 ml undiluted p-chlorotoluene which was fixed by alufole (occlussive condition)
3 weeks after intradermal induction:
Challange with 0.5 ml of 12%- and 0.5 ml of 25%-solution of p-chlorotoluene by dermal application, covered with a plaster, for 24 hours.
Afterwards treatment areas were rinsed with physiological saline-solution.
Evaluation: reading was carried out 48 and 72 hours post start of the challenge; evaluation by comparison of the reacting animals between test and control group.
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
4-chlorotoluene
EC Number:
203-397-0
EC Name:
4-chlorotoluene
Cas Number:
106-43-4
Molecular formula:
C7H7Cl
IUPAC Name:
4-chlorotoluene
Details on test material:
p-chlorotoluene - content: 99.81 %

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Bor: DHPW
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Cremophor E1 in physiological saline
Concentration / amount:
intradermal induction: 5 %
topical induction: 100 %
provocation: 25 % and 12 %
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: Cremophor E1 in physiological saline
Concentration / amount:
intradermal induction: 5 %
topical induction: 100 %
provocation: 25 % and 12 %
No. of animals per dose:
20
Details on study design:
1st application: Induction 5 % intracutaneous
2nd application: Induction undiluted occlusive epicutaneous
3rd application: Challenge other: see freetext ME semiocclusive

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
concentration: 25 %
No. with + reactions:
14
Total no. in group:
20
Clinical observations:
reddening
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: concentration: 25 %. No with. + reactions: 14.0. Total no. in groups: 20.0. Clinical observations: reddening.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
concentration: 25 %
No. with + reactions:
7
Total no. in group:
20
Clinical observations:
reddening
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: concentration: 25 %. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: reddening.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
concentration: 12 %
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
reddening
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: concentration: 12 %. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: reddening.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
concentration: 12 %
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
reddening
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: concentration: 12 %. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: reddening.

Any other information on results incl. tables

no mortality occurred 
body weight development was comparable between test and control animals
Challenge with 25 % solution, positive reactions: 
  48 hour reading: 14/20 and 72 hour-reading 7/20
Challenge with 12 % solution, positive reactions:
  48 hour reading: 3/20 and 72 hour reading 1/20
Control animals showed no reaction at any time point.

Applicant's summary and conclusion

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

method: p-chlorotoluene was tested in a guinea pig maximisation test according Magnusson and Kligman. 20 male animals (control: 10 male animals) per test group were used.

1. Induction: Intradermal application into the back of 0.1 ml p-Chlorotoluene; one week later:

2. Induction: topical application of a plaster containing 0.5 ml undiluted p-chlorotoluene which was fixed by alufole (occlussive condition) 3 weeks after intradermal induction:

Challenge with 0.5 ml of 12%- and 0.5 ml of 25%-solution of p-chlorotoluene by dermal application, covered with a plaster, for 24 hours.

Evaluation: reading was carried out 48 and 72 hours post start of the challenge; evaluation by comparison of the reacting animals between test and control group.

result: After a challenge with a 25% solution of the test substance, 70% of the animals showed a positive reaction, after a challenge with a 12% solution of the test substance15% of the animals showed a positive reaction. Control animals showed no reaction at any time point. Under the condition of the test, p-chlorotoluene has a skin sensitising potential.