Registration Dossier
Registration Dossier
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EC number: 224-081-9 | CAS number: 4196-89-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Similar to the guideline of today, observation time 7 days, no GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Observation period 7 days
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,2-dimethylpropane-1,3-diyl dibenzoate
- EC Number:
- 224-081-9
- EC Name:
- 2,2-dimethylpropane-1,3-diyl dibenzoate
- Cas Number:
- 4196-89-8
- Molecular formula:
- C19H20O4
- IUPAC Name:
- 3-(benzoyloxy)-2,2-dimethylpropyl benzoate
Constituent 1
- Specific details on test material used for the study:
- - yellowish white chunks
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2005-2676 g
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: 9 days
ENVIRONMENTAL CONDITIONS
- temperature and humidity controlled quarters
- The animals were maintained in accordance with the recommendations contained in H.E.W. Publication No.74-23 (N.I.H.) entitled "Guide for the care and use of laboratory animals"
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye of each rabbit
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- not relevant
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- 3 male and 3 female rabbits were used. Prior to test material administration the eyes of each rabbit were examined for corneal lesions with sodium fluorescein solution to exclude rabbits with lesions. The rabbits received 100 mg of the test material into the cupped conjunctival sac of the right eye of each rabbit and then the eyelids were gently held together for 1 second. The left eye served as the untreated control. None of the rabbits received a washout. The evaluation was done according to Draize at 1, 24, 48, 72 hours and at day 7 following installation including fluorescein staining of the cornea.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: from 1 hour up to 7 days
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- other: No effects on corneas of 6/6 rabbits were observed.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1hour up to 7 days
- Score:
- ca. 0
- Max. score:
- 3
- Remarks on result:
- other: No effects were observed in the iris of 6/6 rabbits.
- Irritation parameter:
- other: conjunctiva score (includes redness, chemosis, discharge)
- Basis:
- animal #1
- Time point:
- other: 1 hour - 72 hour
- Score:
- ca. 0.2 - ca. 3.8
- Max. score:
- 20
- Irritation parameter:
- other: conjunctiva score (includes redness, chemosis, discharge)
- Basis:
- animal #1
- Time point:
- other: 7 days
- Score:
- ca. 0
- Max. score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- other: conjunctiva score (includes redness, chemosis, discharge)
- Basis:
- animal #2
- Time point:
- other: 1hour - 24 hour
- Score:
- ca. 3 - ca. 4
- Max. score:
- 20
- Irritation parameter:
- other: conjunctiva score (includes redness, chemosis, discharge)
- Basis:
- animal #2
- Time point:
- other: 48 hour - 7 days
- Score:
- ca. 0
- Max. score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- other: conjunctiva score (includes redness, chemosis, discharge)
- Basis:
- animal #3
- Time point:
- other: 1 hour - 24 hour
- Score:
- ca. 4 - ca. 6
- Max. score:
- 20
- Irritation parameter:
- other: conjunctiva score (includes redness, chemosis, discharge)
- Basis:
- animal #3
- Time point:
- other: 48 hour - 7 days
- Score:
- ca. 0
- Max. score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- other: conjunctiva score (includes redness, chemosis, discharge)
- Basis:
- animal #4
- Time point:
- other: 1 hour - 72 hour
- Score:
- ca. 1 - ca. 3
- Max. score:
- 20
- Irritation parameter:
- other: conjunctiva score (includes redness, chemosis, discharge)
- Basis:
- animal #4
- Time point:
- other: 7 days
- Score:
- ca. 0
- Max. score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- other: conjunctiva score (includes redness, chemosis, discharge)
- Basis:
- animal #5
- Time point:
- other: 1 hour
- Score:
- ca. 5
- Max. score:
- 20
- Irritation parameter:
- other: conjunctiva score (includes redness, chemosis, discharge)
- Basis:
- animal #5
- Time point:
- other: 24 hour - 7 days
- Score:
- ca. 0
- Max. score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- other: conjunctiva score (includes redness, chemosis, discharge)
- Basis:
- animal #6
- Time point:
- other: 1 hour
- Score:
- ca. 4
- Max. score:
- 20
- Irritation parameter:
- other: conjunctiva score (includes redness, chemosis, discharge)
- Basis:
- animal #6
- Time point:
- other: 24 hour - 7 days
- Score:
- ca. 0
- Max. score:
- 20
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- None of the animals showed corneal lesions or effects on the iris. Slight conjunctival redness was observed in all animals, but recovery occurred within 7 days. The very slight chemosis observed at 24 h and the very slight to slight discharge at 1 h disappeared within 48 hours.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 2,2-dimethylpropane-1,3-diyl dibenzoate has to be evaluated as mildly irritating to the eyes of rabbits, which does not lead to classification or labelling.
- Executive summary:
3 male and 3 female rabbits were used. Prior to test material administration the eyes of each rabbit were examined for corneal lesions with sodium fluorescein solution to exclude rabbits with lesions. The rabbits received 100 mg of the test material into the cupped conjunctival sac of the right eye of each rabbit and then the eyelids were gently held together for 1 second. The left eye served as the untreated control. None of the rabbits received a washout. The evaluation was done according to Draize at 1, 24, 48, 72 hours and at day 7 following installation including fluorescein staining of the cornea.
None of the animals showed corneal lesions or effects on the iris. Slight conjunctival redness was observed in all animals, but recovery occurred within 7 days. The very slight chemosis observed at 24 h and the very slight to slight discharge at 1 h disappeared within 48 hours.
Thus 2,2-dimethylpropane-1,3-diyl dibenzoate is evaluated as mildly irritating to the eyes of rabbits.
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