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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report date:
1963

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 2020
Deviations:
yes
Remarks:
please refer to "Principles of method if other than guideline" for details.
Principles of method if other than guideline:
Deviations to OECD guideline 405 (2020): 6 animals/sex used, no systemic analgesics and topical anaesthetics given, no stepwise testing, no information on animals or environmental conditions, limited reporting on procedure and results; conjunctival reactions not discriminated for redness and chemosis (only one value reported), 60% formulation used
GLP compliance:
no
Remarks:
Prior to implementation of GLP.

Test material

Constituent 1
Reference substance name:
9005-00-9 (purity 60%)
IUPAC Name:
9005-00-9 (purity 60%)

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: 1.4 - 2.1 kg

Test system

Vehicle:
water
Remarks:
60% formulation
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
72 h
Observation period (in vivo):
14 days. However only data for 6 days were available.
Reading time points: 1, 24, 48, 72 and 96 h and 7, 10 and 14 days
Number of animals or in vitro replicates:
9 (6 male and 3 female)
6 animals (3 male and 3 female): no washing; 3 animals (3 male): eyes were rinsed after test item instillation
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washing was perfomed in 6/9 animals using 20 mL of water at body temperature
- Time after start of exposure: 2 seconds after test item instillation

SCORING SYSTEM: Draize scoring

TOOL USED TO ASSESS SCORE: not specified

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: Only unwashed animals were regarded for calculation.
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Remarks on result:
other: Only unwashed animals were regarded for calculation.
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of 6 animals
Time point:
24/48/72 h
Score:
0.4
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: Only unwashed animals were regarded for calculation. Score represents a worst case, since individual scores for conjunctivae and chemosis are not given.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of 6 animals
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Only unwashed animals were regarded for calculation. Score represents a worst case, since individual scores for conjunctivae and chemosis are not given.
Irritant / corrosive response data:
The test item showed irritation in 3/6 unwashed eyes 24 h after instillation. In the remaining animals, no irritation was observed for any animal at any reading time point.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
The test substance, applied at a concentration of 60% in water, did not induce eye irritation in an in vivo study similar to OECD guideline 405.