Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This substance is a structural analog (read across) to the target chemical, 3-amino-2-hydroxy-5-nitrobenzenesulphonic acid and have more than 92.6 % similarity.

Data source

Reference
Reference Type:
other: Authoritative data base
Title:
Danish QSAR study for CAS No.: 96-93-5
Author:
Danish EPA Model
Year:
2012
Bibliographic source:
QSAR predictions by Danish Environmental Protection Agency (EPA)model powered by OASIS database; Commercial

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other:
Principles of method if other than guideline:
Sensitization (dermal).Multicase model A33.
GLP compliance:
no
Type of study:
other: GPMT or human experience

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: 3-amino-4-hydroxy-5-nitrobenzenesulphonic acid
- Molecular formula: C6H6N2O6S
- Molecular weight: 234.19
- Substance type: organic

In vivo test system

Test animals

Species:
other: Guinea pig or human
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
other: not specified
Vehicle:
unchanged (no vehicle)

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Clinical observations:
Sensitising
Remarks on result:
other: Reading: 1st reading. Group: test group. Clinical observations: Sensitising.

Any other information on results incl. tables

Positive sensitisation

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
3-amino-4-hydroxy-5-nitrobenzenesulphonic acid is estimated to be skin sensitising.
Executive summary:

3-amino-4-hydroxy-5-nitrobenzenesulphonic acid is estimated to be skin sensitising. Since this substance is a structural analog (read across) to the target chemical, 3-amino-2-hydroxy-5-nitrobenzenesulphonic acid, having more than 92.6 % similarity and thus the toxicity effect can be considered for the target substance as well. Thus it can be infered that 3-amino-2-hydroxy-5-nitro benzene sulphonic acid is skin sensitising.