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

Eye irritation

Administrative data

Endpoint:

eye 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:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye 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 405.

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 / tissue source

Species:

rabbit

Strain:

not specified

Test system

Vehicle:

not specified

Number of animals or in vitro replicates:

2 animals

Results and discussion

In vivo

Results

Remarks on result:

probability of mild irritation

Irritant / corrosive response data:

2 animals showed temporary slight redness

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 eye irritation study from 1979 (not primary irritating), 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.
In this study, 2 animals showed temporary slight redness in the eye, no other signs were noted. This would correspond to a conjunctivae score of 1. Time point was not specified, but as a worst case it is assumed that it is consistent over 24h, 48h, and 72h, and taking into account the minor severity of the effect, it can be reasonable assumed to be reversible within 21 days. Only 2 instead of 3 animals were used, but as Regulation 1272/2008 requires a positive response in at least 2 of 3 animals, it is considered that this deviation is of minor importance and it can be assumed that the hypothetical third animal would show similar responses.
According to Regulation (EC) 1272/2008 table 3.3.2, a substance must be classified as Irritating to eyes (Category 2), if, when applied to the eye of an animal, a substance produces:
— at least in 2 of 3 tested animals, a positive response of:
— corneal opacity ≥ 1 and/or
— iritis ≥ 1, and/or
— conjunctival redness ≥ 2 and/or
— conjunctival oedema (chemosis) ≥ 2
— calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days
No effects on corneal opacity, iritis, or chemosis were stated, and with a conjunctivae score (redness) of 1, classification criteria according to Regulation (EC) 1272/2008 are not met, which is in line with the second WoE study indicating that the substance is not irritating to the eye.

Executive summary:

In an eye irritation study, rabbits (two animals) were exposed to the test substance, both animals showed temporary slight redness.