Registration Dossier
Registration Dossier
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EC number: 907-242-4 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27.August - 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
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- GLP compliance:
- no
Test material
- Reference substance name:
- Alkyl chlorides, C12-14
- EC Number:
- 292-472-1
- EC Name:
- Alkyl chlorides, C12-14
- Details on test material:
- IUCLID4 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
- Breeder:Kleintierfarm Madoerin AG, Fuellingsdorf, Switzerland
- Number and sex: 6 animals (3 males and 3 females)
- Body weigth: 2.3 - 3 kg
- Age- 12 - 16 weeks
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS:
- Diet: Standard Kliba 23/341/1 Rabbit Maintenance Food
- Water: tab water ad libitum
- Housing individually in stainless steel cages
- Temperature: 20°C ± 2°C
- Rel. Humidity: 55% ± 10%
- Light/dark period: 12/12h
Test system
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 male and 3 female rabbits
- Details on study design:
- In 3 animals the eyes were rinsed 30 seconds after application with physiological saline. In the other 3 animals eyes were not rinsed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other:
- Time point:
- other: 24 h to 7 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 h to 7 d
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h to 7 d
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h to 7 d
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The reaction mass alkyl chlorides C12-14 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:
- The test substance 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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