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Registration Dossier
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EC number: 203-975-2 | CAS number: 112-47-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Decane-1,10-diol
- EC Number:
- 203-975-2
- EC Name:
- Decane-1,10-diol
- Cas Number:
- 112-47-0
- Molecular formula:
- C10H22O2
- IUPAC Name:
- decane-1,10-diol
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 Madderin, Fuellinsdorf, Swizerland
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.3 - 3 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 55+/-10
- Air changes (per hr): "air conditioned" without details
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 1h
- Observation period (in vivo):
- 1,24,48,72 hours, 7, 14, 21 days after treatment.
- Number of animals or in vitro replicates:
- 6 rabbits (3M, 3F)
- Details on study design:
- Before testing, both eyes of each animal were examined and any animals with eye defect were rejected.
A single dose of the test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbit and the lid was gently closed for a few seconds.
The right eye remained untreated and served as a control. In 3 out of the 6 rabbits approxiamtely 30 seconds after treatment the treated eye was flushed with physiological saline for about one minute.
Scoring with Draize scale.
All rabbits were killed at the end of the observation period.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- not rinsed
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- not rinsed
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- not rinsed
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- other: not rinsed
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Test item showed no irritation when applied on the rabbit eye mucosa.
No coloration of the cornea and conjunctivae was observed in the rabbits during the entire test period which could be related to compound effects.
Rinsing of the eyes following substance instillation showed a very good effect. - Other effects:
- No acute toxicological signs were observed in the animals during the test period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this experiment, the test material was found to cause no irritation when applied to the rabbit eye mucosa.
- Executive summary:
The purpose of this primary eye irritation study was to assess possible irritation potential when single doses of decanediol are placed in the conjunctival sac of 6 rabbit eyes (3 not rinsed/3 rinsed). Very slight effects on conjunctivae were observed in rabbits 'not rinsed' ; the effects are fully reversible into 7 days.
Under the conditions of this experiment, the test material was found to cause no irritation when applied to the rabbit eye mucosa.
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