Registration Dossier
Registration Dossier
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EC number: 213-156-1 | CAS number: 927-62-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline studies with acceptable restrictions
Data source
Reference
- Reference Type:
- other:
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- N,N-dimethylbutylamine
- EC Number:
- 213-156-1
- EC Name:
- N,N-dimethylbutylamine
- Cas Number:
- 927-62-8
- Molecular formula:
- C6H15N
- IUPAC Name:
- N,N-dimethylbutylamine
- Test material form:
- liquid: viscous
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.36 +/- 0.41 kg
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Animals were held in isolated animal rooms with filtered air suply, temperature and humidity control
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- Group 1: 24 hrs
Group 2: 15 seconds - Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- Group 1: 6 animals; 24 hrs
Group 2: 3 animals; 15 seconds - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Group 2
- Time after start of exposure: 15 seconds
SCORING SYSTEM: Draize (1959); table contained in OECD 405
TOOL USED TO ASSESS SCORE: biomicroscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 13 d
- Score:
- 13.3
- Max. score:
- 80
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- other: unwashed eyes
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 13 d
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- other: iris was not affected at any reading
- Remarks on result:
- other: unwashed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 13 d
- Score:
- 7.3
- Max. score:
- 20
- Reversibility:
- other: redness persisted (score: 1) on day 13 whereas chemosis and discharge were fully reversible. Corneal opacity was not reversible.
- Remarks on result:
- other: unwashed eyes
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Not reported
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Not reported
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Not reported
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Not reported
Applicant's summary and conclusion
- Executive summary:
N,N-dimethylbutylamine was considered to be a severe eye irritant, based on the results of a study that was conducted essentially similar to OECD 405. The eye reactions of rabbits were recorded up to 14 days after the application of 0.1 mL of the test substance into the conjunctival sac of rabbits, either for 24 hours (Group 1, 6 animals) or 15 seconds (Group 2, 3 animals; eye washed with water). The eye reactions of Group 1 animals indicated marked reactions of the cornea and conjunctivae, whereas the iris was not affected. The conjunctival reactions were largely reversible by day 13, whereas the corneal lesions persisted until the end of the observation period. (Cox and Botta, 1979).
The study is considered to be valid with minor restrictions.
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