Registration Dossier

Toxicological information

Eye irritation

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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: Draize test. Sufficiently detailed

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: around 3 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 ml
Duration of treatment / exposure:
16 - 18 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, no detail.
- Time after start of exposure: 16 - 18 hours

SCORING SYSTEM: Draize scale (no other data)

TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.44
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
For more details see table in field " Any other information on results incl. tables".
Other effects:
None

Any other information on results incl. tables

Table: eye irritation score

Individual score
(6 rabbits)
24 h 48 h 72 h
Corneal opacity or ulceration 0/0/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0
Iris 0/0/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0
Conjunctivae: redness 1/1/1/1/1/1 1/0/0/1/0/0 0/0/0/0/0/0
Conjunctivae: chemosis 0/0/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this test, the substance is not irritating to eye.
Executive summary:

In this acute eye irritation/corrosion test, 0.05 ml of the undiluted substance has been applied in a single dose to one of the eyes of six rabbits during 16 - 18 hours. The untreated eyes served as the control. The degree of eye irritation/corrosion was evaluated by scoring lesions of conjunctiva, cornea, and iris, at 24, 48 and 72 hours. The slight irritant effect observed was full reversible within 72 hours. Based on the result of this test, the substance is not classified according to CLP.