Registration Dossier
Registration Dossier
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EC number: 206-114-9 | CAS number: 302-01-2
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, GLP, TS 5 % in water
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
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:
- Hydrazine
- EC Number:
- 206-114-9
- EC Name:
- Hydrazine
- Cas Number:
- 302-01-2
- Molecular formula:
- H4N2
- IUPAC Name:
- hydrazine
- Details on test material:
- IUCLID4 Test substance: other TS: 50 g hydrazine in 1000 ml water
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: adult
- Weight at study initiation: 3.1-3.3 kg
- Housing: individual
- Diet ad libitum
- Water . ad libitum):
- Acclimation period: 14 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- other: diluted in water to yield a 5 % solution
- Controls:
- yes
- Amount / concentration applied:
- Amount applied: 0.1 ml
- Duration of treatment / exposure:
- 24 hour(s)
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 animals 1 eye as the test eye the other served as control
- Details on study design:
- Comment: rinsed after (see exposure time)
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: score = 0 at any time point
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritant / corrosive response data:
- there were no irritational effects observed in none of the animals in test
- Other effects:
- no other effects were reported
Any other information on results incl. tables
There were no irritational effects observed in none of the animals in test.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
5 % hydrazine solution was evaluated as non-irritating to the eyes of rabbits when tested according to OECD TG 405.(Bayer AG 1988).
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