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Toxicological information

Skin sensitisation

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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: GLP guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
The test substance 1,8-naphylenediamine was evaluated for potential skin sensitizing properties in a maximisation test as decribed by Magnusson and Kligman. The test was performed on male guinea pigs. The following test compound concentrations were used in this test:
Intradermal induction: 5 %
Topical induction: 50 %
Challenge: 50% and 25 %
The test concentrations were determined in a dose finding assay.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted in 1992. At this time an OECD guideline for a LLNA was not available.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
content: 99.5%

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:
polyethylene glycol
Concentration / amount:
Intradermal induction: 5 %
Topical induction: 50 %
Challenge: 50% and 25 %
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
polyethylene glycol
Concentration / amount:
Intradermal induction: 5 %
Topical induction: 50 %
Challenge: 50% and 25 %
No. of animals per dose:
Test substance group: 20 animals
Control group: 10 animals

Results and discussion

Positive control results:
No indicative respons for the positive control group

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 20.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
50%
No. with + reactions:
19
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50%. No with. + reactions: 19.0. Total no. in groups: 20.0.
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
16
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 16.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
25%
No. with + reactions:
12
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 12.0. Total no. in groups: 20.0.
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

After the provocation with a 50% suspension 100% of the animals revealed a positive reaction, and after the provocation with a 25% suspension 80% of the animals revealed a positive reaction. In the control group no reaction was observed. The test item was formulated in polyethyleneglycol 400.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
After the challenge with a 50% suspension 100% of the animals revealed a positive reaction, and after the challenge with a 25% suspension 80% of the animals revealed a positive reaction.
Executive summary:

The test substance 1,8-naphylenediamine was evaluated for potential skin sensitizing properties in a maximisation test as decribed by Magnusson and Kligman. The test was performed on male guinea pigs. The following test compound concentrations were used in this test:

Intradermal induction: 5 %

Topical induction: 50 %

Challenge: 50% and 25 %

After the challenge with a 50% suspension 100% of the animals revealed a positive reaction, and after the challenge with a 25% suspension 80% of the animals revealed a positive reaction. In the control group no reaction was observed.

Therefore a classification as Xi, R43 (GHS: Skin Sens.1B) ist justified.