Registration Dossier

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other: Non-GLP, non guideline study, available as unpublished report, limitations in design and/or reporting but otherwise adequate for assessment.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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Anthranilamide
- Physical state: solid /beige
- Analytical purity: 97.3 %
- Lot/batch No.: 0005190619
- Stability under test conditions: stable
- Storage condition of test material: at room temperature
- Water solubility: The amount of 100.9 mg Anthranilamide was added to a volumetric flask. After addition of about 800 mL deionized water, the mixture was stirred for about 2 hours and made up to the mark afterwards. The test substance was completely dissolved, verified by visual inspection (clear solution).

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