Registration Dossier
Registration Dossier
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EC number: 211-776-7 | CAS number: 694-83-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Fed. Reg. 38 No .187 § 1500.42; adopted 1973
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Cyclohex-1,2-ylenediamine
- EC Number:
- 211-776-7
- EC Name:
- Cyclohex-1,2-ylenediamine
- Cas Number:
- 694-83-7
- Molecular formula:
- C6H14N2
- IUPAC Name:
- cyclohexane-1,2-diamine
- Details on test material:
- - Name of test material (as cited in study report): XXVI/645
- Physical state: liquid
- Analytical purity: 99%
- pH: 9
- ratio of cis: trans isomers: 25:75
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: own breed of the test laboratory
- Weight at study initiation: 2.3 - 2.8 kg
- Diet (e.g. ad libitum): ALTROMIN 2023, Altromin GmbH, Lage, D
ENVIRONMENTAL CONDITIONS
not reported
Test system
- Vehicle:
- other: olive oil
- Controls:
- other: the untreated eyes served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Treatment was once
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
no
SCORING SYSTEM: OECD Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 h
- Remarks on result:
- other: Effects already observed 1 h after treatment
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 72 h
- Remarks on result:
- other: Probable values; effects already observed 1 h after treatment
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 72 h
- Remarks on result:
- other: Effects already observed 1 h after treatment
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 h
- Remarks on result:
- other: Effects already observed 1 h after treatment
- Other effects:
- Strong discharge (score 3) was observed in all readings.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the conditions of the test the test substance is corrosive to the rabbit eye.
- Executive summary:
An eye irritation/corrosion test was performed with six rabbits according to a FDA guideline. The animals were exposed to 0.1 ml of test substance. Strong corrosive effects were observed in all animals.
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