Registration Dossier
Registration Dossier
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EC number: 203-981-5 | CAS number: 112-52-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27-August-1981 to 08-September-1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Study was not conducted under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
- Principles of method if other than guideline:
- Guideline for Acute Eye Irritation Testing, interagency regulatory liaison group CPSC, EPA, FDA, OSHA, Jan. 1981
- GLP compliance:
- no
Test material
- Reference substance name:
- 1-chlorododecane
- EC Number:
- 203-981-5
- EC Name:
- 1-chlorododecane
- Cas Number:
- 112-52-7
- Molecular formula:
- C12H25Cl
- IUPAC Name:
- 1-chlorododecane
- Test material form:
- liquid
- Details on test material:
- Test substance: as prescribed by 1.1 - 1.4
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Strain: Rabbit / New Zealand White
- Number and sex: 6 animals (3 males and 3 females)
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS:
- Diet: standard Kliba 23/341/1
- Water: tab water ad libitum
- Housing in groups of 5 animals in MAKROLON cages (type III)
- Temperature: 20°C ± 2°C
- Rel. Humidity: 55% ± 10%
- Light/dark period: 12/12h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 mL - Duration of treatment / exposure:
- Single instillation into the eye.
- Observation period (in vivo):
- observation period 3 weeks after instillation of the compound into the eye
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- In 3 of 6 animals the eyes were flushed with physiological saline 30 seconds after treatment.
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
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Laurylchlorid showed no irritation to rinsed and non-rinsed eyes when applied on the rabbit eye mucosa.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Laurylchlorid showed no irritation to rinsed and non-rinsed eyes when applied on the rabbit eye mucosa. Thus, according to Regulation (EC) 1272/2008 the data are conclusive but not sufficient for classification.
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