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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997
Reliability:
2 (reliable with restrictions)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Route:
intradermal
Vehicle:
other: acetone and Alembicol D
Concentration / amount:
0.1 ml of the test substance (1% w/v) in 5% acetone in Alembicol D
Route:
epicutaneous, semiocclusive
Vehicle:
other: acetone and Alembicol D
Concentration / amount:
0.1 ml of the test substance (1% w/v) in 5% acetone in Alembicol D
No. of animals per dose:
5 control animals: 10 test animals
Details on study design:
MAIN STUDY

A. INDUCTION EXPOSURE

DAY O:
- Test groups: 10 animals
- No. of exposures: 3 intradermal injections on day 0
- 0.1 ml of Freund's complete adjuvant (FCA) in distilled water,
- 0.1 ml of the test substance (1% w/v) in 5% acetone in Alembicol
- 0.1 ml of the test substance (1% w/v) in 50% aqueous FCA (50%) and 5% in acetone in Alembicol
- Control group: 5 animals given the same injections without the test substance

DAY 6: topical application site treated with 10% (w/v sodium lauryl sulphate in petrolatum

DAY 7
- 0.4 ml of the test substance in acetone (70%) was applied to the skin of each animal and held in place for 48 hours using semi-occlusive wrap

Control animals treated in the same manner without the test substance.

B. CHALLENGE EXPOSURE

Both control and test animals challenged topically 2 weeks after the topical inductin application using the test substance, 35% w/v (posterior site) and 70% w/w (anterior site) in acetone. Application with semi-occlusive wrap for 24 hours. Evaluation at 24, 48 and 72 hours after challenge.


Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
35%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 35%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
70%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 70%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
35%
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 35%. No with. + reactions: 3.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
70%
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 70%. No with. + reactions: 5.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
35%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 35%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
70%
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 70%. No with. + reactions: 3.0. Total no. in groups: 10.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance showed evidence of skin sensitiation in the Guinea Pig Maximisation Test.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:
Migrated from Short description of key information:
The test substance showed evidence of skin sensitiation in the Guinea Pig Maximisation Test.

Justification for selection of skin sensitisation endpoint:
Only one skin sensitisation stud was conducted with the test substance.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There is no information available for respiratory sensitisation. Therefore, there is a data gap in this respect. However, the data gap cannot fulfilled with experimental data, since there is no internationally accepted animal model for respiratory sensitisation. In case human data for respiratory sensitisation emerge, this will be taken into account.

Justification for classification or non-classification

Based on the findings in the adjuvant sensitisation test (M & K) in guinea pigs, the test substance needs to be classified and labelled as a skin sensitiser, according to the Regulation 1271/2008 and the Directive 67/548/EEC.