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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Remarks:
source of read across
Adequacy of study:
weight of evidence
Study period:
June from 11 to 25, 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 12 May 1981
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Similar Substance 01
IUPAC Name:
Similar Substance 01

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund.

Test system

Amount / concentration applied:
100 mg per eye
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 animals
Details on study design:
SCORING SYSTEM
Draize test system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 1
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 1
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Basis:
animal: 2/3
Time point:
24/48/72 h
Score:
2.3 - 2.7
Remarks on result:
probability of mild irritation
Irritation parameter:
chemosis score
Basis:
animal: 2/3
Time point:
24/48/72 h
Score:
< 2
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
On the basis of the numerically evaluated individual findings at observation times after 24, 48 and 72 hours, the following mean values were calculated:
animal 58: corneal opacity 0, iris 0.3, conjuntival redness 2.3, conjunctival chemosis 2.0
animal 78: corneal opacity 0, iris 0, conjuntival redness 1.3, conjunctival chemosis 0.3
animal 80: corneal opacity 0, iris 0, conjuntival redness 2.7, conjunctival chemosis 1.0

Applicant's summary and conclusion

Conclusions:
Weakly irritating
Executive summary:

The primary eye irritation potential of test item was investigated by the application of 100 mg of test item to three New Zealand White rabbits. The method and procedures followed were in accordance with those outlined into the OECD guideline 405 and EU method B5. The scoring of eye reactions was performed 1, 24, 48 and 72 hours after removal of the dressing, according to the Draize system.

On the basis of the numerically evaluated individual findings at observation times after 24, 48 and 72 hours, the following mean values were calculated: animal 58 corneal opacity 0, iris 0.3, conjuntival redness 2.3, conjunctival chemosis 2.0; animal 78 corneal opacity 0, iris 0, conjuntival redness 1.3, conjunctival chemosis 0.3; animal 80 corneal opacity 0, iris 0, conjuntival redness 2.7, conjunctival chemosis 1.0.

The substance resulted to be weakly irritating.

Conclusion

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for conjunctival oedema, in two out of three tested animals; the value for conjuntival redness resulted to be higher than 2 in two out of three animals.

Therefore, the substance meets the criteria to be classified as eye irritating, category 2 (H319), according to the CLP Regulation (EC) No 1272/2008.