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: Guideline study according to national standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: US Code of Federal Regulations, Title 16, Section 1500.42
Principles of method if other than guideline:
100 mg were administered to the conjunctival sac and scoring was done after 24, 48 and 72 h according to Draize
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 'Anthrazen reinst'
Product No. 110 147

Test animals / tissue source

Species:
rabbit
Strain:
other: albino

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:
unlimited, not rinsed
Observation period (in vivo):
24, 48, 72 h and 7 d post-application
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:


SCORING SYSTEM: Draize numerical scoring system for grading ocular irritation effects adopted by ETAD
(Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics,
published by Food and Drug Officials USA 1959)


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Remarks:
calculated from weighted irritation effects
Basis:
mean
Remarks:
6 animals
Time point:
other: 24 h post application
Score:
10
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
maximum mean total score (MMTS)
Remarks:
calculated from weighted irritation effects
Basis:
mean
Remarks:
6 animals
Time point:
other: 48 h post application
Score:
6
Max. score:
110
Reversibility:
fully reversible
Irritant / corrosive response data:
4/6 rabbits with slight transient redness of the conjunctivae (irritation score = 1.0) on day 1 or 2;
1/6 animals without signs of irritation (irritation score 0);  
1/6 with moderate redness (irritation score 2 on day 1 and 2, score 1 on day 3 and 7)
and increased secretion (score 1 on day 1).

Applicant's summary and conclusion

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