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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

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other: Non-GLP, non guideline study, available as unpublished report, limitations in design and/or reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
1971

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
According to BASF-internal standard. Two rabbits (1 male, 1 female) were exposed to the undiluted test substance in the eye followed by a 8 day observation period.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
88-68-8
IUPAC Name:
88-68-8
Details on test material:
- Name of the test substance used in the study report: Anthranilsaeureamid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
- Weight of female animal: 2.76 kg
- Weight of male animal: 2.96 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye of the same animal
Amount / concentration applied:
ca. 50 mg
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
The test substance was not washed out.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: control eye also showed effects on conjunctiva (reversible after 72 h)
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: control eye also showed conjuctiva effects up to 8 days after substance application
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 h
Score:
1.67
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritant / corrosive response data:
Blood was observed in the exposed eye of animal one at 1 hour after exposure, but was absent thereafter

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information