Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
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
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

Constituent 1
Chemical structure
Reference substance name:
1,8-naphthylenediamine
EC Number:
207-529-8
EC Name:
1,8-naphthylenediamine
Cas Number:
479-27-6
Molecular formula:
C10H10N2
IUPAC Name:
naphthalene-1,8-diamine
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 chemical
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 chemical
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 chemical
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 chemical
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.