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EC number: 229-755-6 | CAS number: 6707-60-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The method of procedure is that suggested by Dr. Draize and described in "Appraisal of the safety of chemicals in foods, drugs amd cosmetics" published by the Association of Food and Drug Officials of the United States.
- GLP compliance:
- no
Test material
- Reference substance name:
- 12-oxahexadecan-16-olide
- EC Number:
- 229-755-6
- EC Name:
- 12-oxahexadecan-16-olide
- Cas Number:
- 6707-60-4
- Molecular formula:
- C15H28O3
- IUPAC Name:
- 1,6-dioxacycloheptadecan-7-one
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Test material name (as stated in the report): GIV 81-1543=Musc 174
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino rabbits
- Details on test animals or tissues and environmental conditions:
- Three normal, healthy albino rabbit were used in this experiment
Test system
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1mL of test materia
- Duration of treatment / exposure:
- instillation
- Observation period (in vivo):
- 14 days after instillation
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- Ecah animal had 0.1 mL of test sample instilled into the right eye with no further treatment.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal:
- Remarks:
- animal #1 ; animal #2 and animal 3#
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Na
- Irritation parameter:
- iris score
- Basis:
- animal: animal #1 ; animal #2 and animal 3#
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Na
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: animal #1 ; animal #2 and animal 3#
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- animal: animal #1 ; animal #2 and animal 3#
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Na
- Irritation parameter:
- other: Ulceration
- Basis:
- animal: animal #1 ; animal #2 and animal 3#
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Na
Any other information on results incl. tables
The scorings recorded were made according to the Draize scale for scoring ocular lesions.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CERVOLIDE does not meet the criteria to be as Eye irritant Category 2 according to the CLP Regulation (EC) No. 1272/2008.
- Executive summary:
The CERVOLIDE was tested in this study to determine his eye irritant potential according to the procedure is that suggested by Dr. Draize and described in "Appraisal of the safety of chemicals in foods, drugs amd cosmetics" published by the Association of Food and Drug Officials of the United States.
Observations and scoring by the Draize method were conducted immediately and 1 hour, 24 hours, 48 hours, 72 hours, 7 days and 14 days later. With 10%, conjunctival redness was observed in 3/3 animals at 1 hour and 24 hours. Reactions were absent by 48 hours. With 30%, conjunctival redness was observed in 3/3, 3/3 and 1/3 animals at 1 hour, 24 hours and 48 hours, respectively. Reactions were absent by 72 hours.With the neat material, conjunctival redness was observed in 3/3, 1/3 and 3/3 animals at 1 hour, 24 hours and 48 hours, respectively. Moderate conjunctival redness was observed in 2/3 animals at 24 hours. Chemosis was observed in 3/3 animals at 24 hours. Dose: 100 % Effects: eye effects; irritant effects Results: moderate conjunctival irritation which cleared within 72 hours
CERVOLIDE does not meet the criteria to be as Eye irritant Category 2 according to the CLP Regulation (EC) No. 1272/2008.
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