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Toxicological information

Eye irritation

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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Desmodur VP.PU 1806
- Physical state: colorless, clear liquid
- Analytical purity: see composition of test material
- Composition of test material, percentage of components: 2,2'-Diisocyanatodiphenylmethane 0.64%, 2,4'-Diisocyanatodiphenylmethane 53.60% and 4,4'-Diisocyanatodiphenylmethane 45.72%.
- Manufacturer: Bayer AG, Liverkusen
- Stability under test conditions: guaranteed for the study period
- Storage condition of test material: room temperature, in nitrogen

Test animals / tissue source

Species:
rabbit
Strain:
other: HC:NZW
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfaune UK Ltd.
- Mean body weight at study initiation: 3.43 Kg (2.9 - 3.8 Kg)
- Diet (e.g. ad libitum): Standard diet "Ssniff", approx. 100-120 g per animal/day, once per day in the morning
- Water (e.g. ad libitum): tap water
- Acclimation period:


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): approx. 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml instilled into the conjuctival sac
Duration of treatment / exposure:
24 h
Observation period (in vivo):
21 d
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with saline
- Time after start of exposure: 24 h


SCORING SYSTEM: Draize score

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects in all 3 animals
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects in all 3 animals
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects in all 3 animals
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects in all 3 animals
Irritant / corrosive response data:
no irritation responses were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Based on the test results, the test substance is not irritating to eyes according to EU and GHS classification.