6-amino-4-hydroxynaphthalene-2-sulphonic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

other: Summary of study results

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

No guideline specified, but from available information it can be concluded that it has been conducted similar to OECD 404.

GLP compliance:

no

Remarks:

Study conducted prior to GLP

Test material

Test material information

Constituent 1

Reference substance name:

6-amino-4-hydroxynaphthalene-2-sulphonic acid

EC Number:

202-000-8

EC Name:

6-amino-4-hydroxynaphthalene-2-sulphonic acid

Cas Number:

90-51-7

Molecular formula:

C10H9NO4S

IUPAC Name:

6-amino-4-hydroxynaphthalene-2-sulphonic acid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3-4 kg
- Housing: separately
- Diet (e.g. ad libitum): species-specific, ad libitum
- Water (e.g. ad libitum): ad libitum

Test system

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg per animal

Duration of treatment / exposure:

24 h

Observation period:

7 d

Number of animals:

2

Details on study design:

TEST SITE
- Type of wrap if used: Substance was attached to ear with the aid of adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after exposure test substance was washed off with water and soap
- Time after start of exposure: 24h

Results and discussion

In vivo

Results

Remarks on result:

other: not irritant

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Data alone cannot be used for assessment, but taking into account the results from this study and the skin irritation study from 1974 (not irritating, only slight redness has been observed in one animal), it can be stated that the GHS criteria are not met for this endpoint and hence, classification is not needed (see Conclusions for further information).

Conclusions:

The documentation of the present study is not sufficient to assess reliability of result (Klimisch 4), hence weight of evidence approach is used to fill this endpoint sufficiently.
Given data indicate that the study was performed similar to OECD 404, except that only two instead of three animals were used. Exposure duration was 24h. According to OECD TG 404, exposure duration should be 4h. Hence, the present study is in general likely to overestimate the irritating properties of the substance. The substance was stated to be not irritating to the skin, and due to the longer exposure duration, it is not expected that this result could underestimate the actual hazard. Non-irritant properties are additionally in line with the second WoE study, and no need for classification is obvious, as Regulation 1272/2008 also foresees a WoE-approach.

Executive summary:

In a dermal irritation study, rabbits (New-Zealand White, two animals) were dermally exposed to 500 mg of the test substance for 24h (observation period 7 days). The substance has been determined to be not irritating to rabbit skin.