Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report Date:
1967

Materials and methods

Principles of method if other than guideline:
0.1 mL of the test substance was instilled onto the mucosa of rabbits as single application or washed away after 2 sec. The mucosa was evaluated for up to 7 days to score the irritation potential according to the Draize scoring system.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Analytical purity: approx. 90%
- Impurities (identity and concentrations): propylene glycol, 11%
- Lot/batch No.: 5850

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.0 - 2.4 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
a) single application without washing (6 eyes) and
b) washing 2 sec after substance application (3 eyes)
Observation period (in vivo):
7 days
Reading time points: 1, 24, 48, 72 and 96 h and 7 days
Number of animals or in vitro replicates:
1 male and 8 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was rinsed with water at body temperature.
- Time after start of exposure: 2 sec

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibilty: not applicable
Remarks on result:
other: single application without washing
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibilty: not applicable
Remarks on result:
other: single application without washing
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibilty: not applicable
Remarks on result:
other: single application without washing
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: washing 2 sec after substance application
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: washing 2 sec after substance application
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibilty: not applicable
Remarks on result:
other: washing 2 sec after substance application
Irritant / corrosive response data:
Animals exposed to a single application without washing did not show any signs of eye irritation. In contrast, 1 out of 3 animals showed a slight conjunctival irritation (conjunctivae score 2 at reading time point 1 h after substance application) when the substance was rinsed away with water. As the effect was reversible already after 24 h and the exposure to the test substance occured for only 2 sec, the effect might be due to the washing procedure.

Applicant's summary and conclusion

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