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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from Authoritive Data Base

Data source

Reference
Reference Type:
other: Authoritive Data Base
Title:
Skin sensitization CAS No: 2243-62-1 (1,5-Naphthalenediamine)
Author:
IFA (GESTIS)
Year:
2016
Bibliographic source:
GESTIS Substance Database (Information System in Hazardous Substance of the Berufsgenossenscheftn)

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
The skin sanitization test of 1, 5 Naphthalenediamine was conducted in humans to determine its sensitization potential.
GLP compliance:
not specified
Type of study:
not specified

Test material

Constituent 1
Reference substance name:
1, 5-Naphthalenediamine
IUPAC Name:
1, 5-Naphthalenediamine
Constituent 2
Reference substance name:
1,5-naphthylenediamine
EC Number:
218-817-8
EC Name:
1,5-naphthylenediamine
Cas Number:
2243-62-1
IUPAC Name:
naphthalene-1,5-diamine
Test material form:
other: solid
Details on test material:
- Name of test material (as cited in study report): 1, 5-Naphthalenediamine (ND)
- Molecular formula: C10H10N2
- Molecular weight: 158.203g/mol
- Substance type: organic
- Physical state: solid
- Smiles: c12c(c(ccc2)N)cccc1N
-InChI:1S/C10H10N2/c11-9-5-1-3-7-8(9)4-2-6-10(7)12/h1-6H,11-12H2

In vivo test system

Test animals

Species:
human
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: no data
Vehicle:
no data
Concentration / amount:
No data available
Challengeopen allclose all
Route:
other: no data
Vehicle:
no data
Concentration / amount:
No data available
No. of animals per dose:
No data available
Details on study design:
No data available
Challenge controls:
No data available
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
Clinical observations:
Potential contact allergen
Remarks on result:
other: Reading: 1st reading. Group: test group. Clinical observations: Potential contact allergen.

Any other information on results incl. tables

The substance is a potential contact allergen

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material 1, 5-Naphthalenediamine (CAS No:- 2243-62-1)observed to be sensitizing to humans.
Executive summary:

The skin sensitization study of 1, 5-Naphthalenediamine (CAS No:-2243-62-1) was performed in humans to determine its sensitization.

 

Since the test chemical produced potential contact allergy,1, 5-Naphthalenediamine(CAS No: -2243-62-1) can be concluded as skin sensitizer.