Registration Dossier
Registration Dossier
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EC number: 258-751-7 | CAS number: 53767-93-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Test conducted prior to the GLP guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: FDA of the United States
- Version / remarks:
- FDA of the United States (Fed. Reg .28 (119), 5582 1963)
- Qualifier:
- according to guideline
- Guideline:
- other: Draize and Kelley
- Version / remarks:
- Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36)
- GLP compliance:
- no
- Remarks:
- Test conducted prior to the GLP guidelines
Test material
- Reference substance name:
- 2,6-dimethyloct-7-en-2-yl acetate
- EC Number:
- 258-751-7
- EC Name:
- 2,6-dimethyloct-7-en-2-yl acetate
- Cas Number:
- 53767-93-4
- Molecular formula:
- C12H22O2
- IUPAC Name:
- 2,6-dimethyloct-7-en-2-yl acetate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Clear colorless liquid designed Dihydromyrcenylacetate (Institute's code: DHMA) was received on 19th Januray, 1979.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Six New Zealand White albino rabbits are used for each test substance. The animals are cages individually and receive no hay or other extraneous materials that might enter the eyes.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 10 ml of undiluted test material
- Duration of treatment / exposure:
- instillation
- Observation period (in vivo):
- The eyes were examined at 24, 48, 72 hours and 7 days after instillation of the test material.
- Duration of post- treatment incubation (in vitro):
- none
- Number of animals or in vitro replicates:
- Six New Zealand White albino rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other:
- Remarks:
- Mean of 2 animals and only 24 and 48 hours scored
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other:
- Remarks:
- mean of 2 animals
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other:
- Remarks:
- Mean of 2 animals
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other:
- Remarks:
- Mean of 2 animals and only 24 and 48 hours scored
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other:
- Remarks:
- Mean of 2 animals
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other:
- Remarks:
- Mean of 2 animals
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other:
- Remarks:
- Mean of 2 animals and only 24 and 48 hours scored
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other:
- Remarks:
- Mean of 2 animals
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other:
- Remarks:
- Mean of 2 animals and only 24 and 48 hr scored
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other:
- Remarks:
- Mean of 2 animals
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other:
- Remarks:
- Mean of 2 animals
- Irritant / corrosive response data:
- DHMA caused slight conjunctivitis in one out of six rabbits. After 48 hours the eye effects has cleared up.
Any other information on results incl. tables
An animal is considered as giving a positive reaction if there is, at any of the reading, discernible opacity of the cornea or inflammation of the iris (other than a slight dulling of the normal lustre), or ulceration of the cornea, or inflammation of the iris (other than a slight deepening of the folds (rugae) or a slight circumcorneal injection) or if such susbtance produces in the conjunctivae (palpebral and bulbar, excluding the cornea and iris) an obvious swelling with the partial eversion of the lids, or a diffuse deep-crimson red with individual vessels not easily discernible. The FDA scoring scale is used.
Applicant's summary and conclusion
- Interpretation of results:
- other: not an eye irritant
- Remarks:
- according to EU CLP (EC No. 1272/2008 and its amendments).
- Conclusions:
- The substance caused slight conjunctivitis in one out of six rabbits. After 48 hours the eye effects has cleared up. Therefore the substance is not considered to be an eye irritant.
- Executive summary:
The substance was examined for eye irritation according to the Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36) and FDA of the United States (Fed. Reg .28 (119), 5582 1963) methods, somewhat similar to OECD TG 405. The eyes of animals are examined before testing and only those animals without observable eye defects are used. One tenth of milliliter of the test substance is allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower eye lid are then carefully closed and subsequently held together for at least one second before releasing to prevent the loss of material. The eyes are not washed following instillation and the animals are released immediately. The substance caused slight conjunctivitis in one out of six rabbits. After 48 hours the eye effects has cleared up. Therefore the substance is not considered to be an eye irritant.
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