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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: data from safety assessment reports

Data source

Reference
Reference Type:
review article or handbook
Title:
7-Amino-4-hydroxy-2-naphthalenesulfonic acid
Author:
BG Chemie
Year:
2000
Bibliographic source:
BG Chemie InfoCenter, TOXIKOLOGISCHE BEWERTUNGEN; TOXICOLOGICAL EVALUATION last updated: 06/2000

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To assess the eye irritation potential of the test substance using Standard Draize test
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Name of test material (as cited in study report): 7-Amino-4-hydroxy-2-naphthalenesulfonic acid
Molecular formula: C10H9NO4S
Molecular weight: 239.25g/mol
Substance type: organic
Physical state: solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
24 hours
Number of animals or in vitro replicates:
no data
Details on study design:
area of exposure: conjunctival sac

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24
Remarks on result:
other: mild irritation was observed after 24 hours

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:

In a eye irritation study, approx. 500 mg 7-amino-4-hydroxy-2-naphthalenesulfonic acid (I acid) was instilled into the eyes of the rabbits.
Mild eye irritation was observed after 24 hours
Hence the test chemical can be considered non-irritant to rabbit eyes.
Executive summary:

In an eye irritation study in rabbits, 50 mg 7-amino-4-hydroxy-2-naphthalenesulfonic acid (I acid) was instilled into the conjunctival sac of 2 animals

New Zealand white rabbits were used for the study.

The animals were observed for 24 hours

Mild eye irritation was observed after 24 hours.

Hence the test chemical can be considered non-irritant to rabbit eyes