Registration Dossier
Registration Dossier
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EC number: 203-915-5 | CAS number: 111-85-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study report is not complete.
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: Proposed guidelines of US EPA paragraph 163.81-4 "Primary Eye Irritation Study", Federal register, Vol. 43, No. 163, August 22, 1978
- Deviations:
- not specified
- Principles of method if other than guideline:
- Procedure as given in guideline cited. Scoring of eye irritation according to Draize (1959).
- GLP compliance:
- no
- Remarks:
- no GLP implemented at that time
Test material
- Reference substance name:
- 1-chlorooctane
- EC Number:
- 203-915-5
- EC Name:
- 1-chlorooctane
- Cas Number:
- 111-85-3
- Molecular formula:
- C8H17Cl
- IUPAC Name:
- 1-chlorooctane
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf, Switzerland
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.3-3.0 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 27. August 1981 To: 08. September 1981
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye of each animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 3 animals: 30 seconds, thereafter rinsing
3 animals: 14 days (no rinsing) - Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- 0.1 mL of the test item was inserted into the conjuctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. In 3 out of 6 animals approximately 30 seconds after treatment the treated eye was flushed with physiological saline for about one minute.
The eyes were examined and the grade of ocular reactions recorded at 24, 48 and 72 hours, 4, 7, 14 and 21 days after treatment, unless the eye is normal at 7 or 14 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: rinsed and unrinsed eyes
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: rinsed and unrinsed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: rinsed and unrinsed eyes
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: rinsed and unrinsed eyes
Any other information on results incl. tables
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Under the conditions of the study the test item was not irritating to the eye in rabbits.
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