Registration Dossier
Registration Dossier
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EC number: 202-494-5 | CAS number: 96-26-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- performed before OECD GLP regulation became effective
Test material
- Reference substance name:
- 1,3-dihydroxyacetone
- EC Number:
- 202-494-5
- EC Name:
- 1,3-dihydroxyacetone
- Cas Number:
- 96-26-4
- Molecular formula:
- C3H6O3
- IUPAC Name:
- 1,3-dihydroxyacetone
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Three male White New Zealand rabbits were used.
TEST ANIMALS
- Source: E. Merck
- Age at study initiation: no infomation provided
- Weight at study initiation: mean 2,78 kg (2,61 - 2,91 kg)
- Housing: individual cages (Becker)
- Diet: Altromin, ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature, Humidity, Air changes, Photoperiod: no information provided
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg per animal
- Duration of treatment / exposure:
- The applied test material was not rinsed off.
- Observation period (in vivo):
- The rabbits were examined for eye irritation daily up to day 7 of the study.
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- Aliquots of 0.1 g DHA were applied into the conjunctival sac of the left eye of each rabbit. The right eye remained untreated and served as a control. After treatment the rabbits were examined for eye irritation daily up to one week. Eye reactions were evaluated and graded according to Draize (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA Baltimore, 1959).
REMOVAL OF TEST SUBSTANCE
- Washing: not performed
SCORING SYSTEM: according to Draize (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA Baltimore, 1959)
TOOL USED TO ASSESS SCORE: hand-slit lamp
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:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- erythema
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- erythema
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- erythema
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Eye reactions were evaluated and graded according to Draize scale. After instillation of the test material, no irritancy was observed in two animals. One animal showed a slight transient erythema of the conjunctiva from 24 hours after instillation up to day 3 of the observation period. Scores are established from the observations described in the report.The scores are not mentioned in the study report.
- Other effects:
- No clinical signs were observed. The development of body weight was inconspicious.
Any other information on results incl. tables
No individual scores on eye irritation were provided in the report. However, only one animal showed a slight reddening of the conjunctivae from day 1 to day 3. No irritating effects were observed in the two remaining animals. Therefore, the test material is evaluated as not irritating to the eyes.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: US CPSC / US FDA
- Conclusions:
- Based on the results of this study, undiluted test item is evaluated as non-irritating to the eyes
- Executive summary:
The test material was tested for acute eye irritation in three male rabbits (New Zeeland). Aliquots of 0.1 g were applied into the conjunctival sac of the left eye of each rabbit. The right eye remained untreated and served as a control. The rabbits were examined for eye irritation daily up to day 7 of the study. Eye reactions were evaluated and graded according to Draize scale. After instillation of the test material, no irritancy was observed in two animals. One animal showed a slight transient erythema of the conjunctiva from 24 hours after instillation up to day 3 of the observation period. Based on the results of this study, undiluted test material is evaluated as non-irritating to the eyes.
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