Registration Dossier
Registration Dossier
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EC number: 211-103-7 | CAS number: 629-70-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not applicable
- GLP compliance:
- no
- Remarks:
- investigation conducted prior to introduction of GLP
Test material
- Reference substance name:
- Hexadecyl acetate
- EC Number:
- 211-103-7
- EC Name:
- Hexadecyl acetate
- Cas Number:
- 629-70-9
- Molecular formula:
- C18H36O2
- IUPAC Name:
- hexadecyl acetate
- Details on test material:
- - Name of test material (as cited in study report): Acetulan
- Physical state: Clear light yellow liquid
- Analytical purity: Declared by owner of study report to contain 90 % test item and to be equivalent to the substance described elsewhere in this dossier
- Lot/batch No.: 814
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or tissues and environmental conditions:
- - The study was conducted on six young adult albino rabbits selected from healthy, acclimated, animals according to the procedure described in 16 CFR 1500.42.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Not stated
- Duration of treatment / exposure:
- No washout
- Observation period (in vivo):
- Seven days
- Number of animals or in vitro replicates:
- Six
- Details on study design:
- - Ocular reactions were observed and recorded at 24, 48 and 72 hours after instillation of the test material (see scoring scheme, attached).
- The ocular reactions were also observed and recorded at 7 days after instillation of the test material.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animals 1 to 6
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animals 1 to 6
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.89
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: Animals 1 to 6
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.39
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: Animals 1 to 6
- Irritant / corrosive response data:
- - Individual eye irritation scores are shown in the attached document.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was found to be a mild irritant to the rabbit eye when not followed by a washout after instillation. However, the test material is not classified under the terms of Regulation (EC) No 1272/2008 because the mean scores for each of six animals calculated using data from 24, 48 and 72 hour observations were below the stated limits for corneal opacity, iritis, conjunctival redness and chemosis.
- Executive summary:
METHOD
Acute eye irritation was investigated in the rabbit using a mixture declared to contain 90 % of test item.
RESULTS
Conjunctival effects were observed in all six animals but, with the exception of discharge, these effects cleared in five animals during the seven day observation period.
CONCLUSION
The test material was found to be a mild irritant to the rabbit eye when not followed by a washout after instillation. However, the test material is not classified under the terms of Regulation (EC) No 1272/2008 because the mean scores for each of six animals calculated using data from 24, 48 and 72 hour observations were below the stated limits for corneal opacity, iritis, conjunctival redness and chemosis.
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