Registration Dossier
Registration Dossier
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EC number: 701-276-1 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- 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:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methylenediphenyl diisocyanate
- EC Number:
- 247-714-0
- EC Name:
- Methylenediphenyl diisocyanate
- Cas Number:
- 26447-40-5
- IUPAC Name:
- 1,1'-methylenebis(2-isocyanatobenzene)
- Reference substance name:
- benzene, 1,1'-methylenebis[isocyanato
- IUPAC Name:
- benzene, 1,1'-methylenebis[isocyanato
- 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
Constituent 1
Constituent 2
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:
- other: 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:
- other: 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:
- other: 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:
- other: 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.
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