Registration Dossier
Registration Dossier
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EC number: 203-600-2 | CAS number: 108-62-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April - May 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,4,6,8-tetramethyl-1,3,5,7-tetraoxacyclooctane
- EC Number:
- 203-600-2
- EC Name:
- 2,4,6,8-tetramethyl-1,3,5,7-tetraoxacyclooctane
- Cas Number:
- 108-62-3
- Molecular formula:
- C8H16O4
- IUPAC Name:
- 2,4,6,8-tetramethyl-1,3,5,7-tetraoxocane
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Description: White powder
- Name: P0071
- Storage requirements: approx.. 4°C in the refrigerator
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Rosemead Rabbits, Waltham Abbey, Essex, U.K.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.71-2.98 kg
- Housing: individual housing
- Diet (e.g. ad libitum): Rabbit Diet, Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K.
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-19°C
- Humidity (%): 43-47%
- Air changes (per hr): 15 changes/h
- Photoperiod (hrs dark / hrs light): 12h light / 12h darkness
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml test material
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1 hour and 24, 48 and 72 hours following treatment
- Duration of post- treatment incubation (in vitro):
- not applicable; in-vivo test
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: n/a
SCORING SYSTEM:
- modified version of the system described by Kay J.H. and Calandra J.C., J. Soc. Cosmet. Chem., 1962,13, p 281-289
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:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- A single application of the test material to the non-irrigated eye of three rabbits produced transient iridial inflammation and minimal conjunctival irritation. All treated eyes appeared normal at the 48-hour observation.The test material produced a maximum group mean score of 11.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. However, GHS-criteria for classification are not met.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was found to be non-irritating to rabbit eyes.
- Executive summary:
A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD No. 405. A single application of the test material to the non-irrigated eye of three rabbits produced transient iridial inflammation and minimal conjunctival irritation. All treated eyes appeared normal at the 48-hour observation. The test material produced a maximum group mean score of 11.0 and was classified .as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. However, the test material was classified as non-irritant according to the current GHS-criteria.
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