Registration Dossier
Registration Dossier
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EC number: 269-348-0 | CAS number: 68227-33-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Act-Reference: Section 1500.42 (b) (1) (2) P. 27019
- GLP compliance:
- no
- Remarks:
- done before establishment of GLP
Test material
- Reference substance name:
- 2,5,8,11-tetramethyldodec-6-yne-5,8-diol
- EC Number:
- 269-348-0
- EC Name:
- 2,5,8,11-tetramethyldodec-6-yne-5,8-diol
- Cas Number:
- 68227-33-8
- Molecular formula:
- C16H30O2
- IUPAC Name:
- 2,5,8,11-tetramethyldodec-6-yne-5,8-diol
- Reference substance name:
- 2,5,8,11-tetramethyl-6-dodecyne-5,8-diol
- IUPAC Name:
- 2,5,8,11-tetramethyl-6-dodecyne-5,8-diol
- Test material form:
- other: waxy solid
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 gr
- Duration of treatment / exposure:
- see method description
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: day 1
- Score:
- 38.5
- Max. score:
- 41
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: day2
- Score:
- 47
- Max. score:
- 57
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: day 3
- Score:
- 40.2
- Max. score:
- 53
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: day 5
- Score:
- 23.3
- Max. score:
- 29
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: day 7
- Score:
- 23.3
- Max. score:
- 25
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the accompanied data, the subject material is a primary occular irritant within the definition of the act reference: Section 1500.42 (b) (1) 82) P. 27019 and requires cautionary labeling with respect to that section.
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