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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline with acceptable restrictions (partly limited documentation; 50 μl instead of 100 mg test substance instilled). Study sufficient for evaluation of this endpoint.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1960
Report date:
1960

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
application volume (50 mg), 2 animals, no washing
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
sodium 2-amino-5-methylbenzenesulfonate
EC Number:
611-210-2
Cas Number:
54914-95-3
Molecular formula:
C7 H8 N O3 S Na
IUPAC Name:
sodium 2-amino-5-methylbenzenesulfonate
Details on test material:
- Name of test material (as cited in study report): Natriumsalz der 4-Toluidin-3-sulfosaeure (sodium salt, pure, solid)
- Analytical purity: no data, pure

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.48 - 2.53 kg

ENVIRONMENTAL CONDITIONS
not reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: one drop of saline into the other eye
Amount / concentration applied:
50 mg
Duration of treatment / exposure:
Treatment was once. The eye was left unwashed.
Observation period (in vivo):
4 days
Number of animals or in vitro replicates:
2
Details on study design:
SCORING SYSTEM
Descriptive scores have been converted into OECD/ Draize scoring system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 1/2 animals was completely free from effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects

Applicant's summary and conclusion

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