Registration Dossier
Registration Dossier
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EC number: 294-785-9 | CAS number: 91770-03-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 September 1982 - 20 October 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP-like study (QA signature)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: 16 CFR 1500.42 Federal Hazardous Substances Act
- GLP compliance:
- yes
- Remarks:
- GLP-like study (QA signature)
Test material
- Reference substance name:
- Fatty acids, tall-oil, reaction products with boric acid (H3BO3) and diethanolamine
- EC Number:
- 294-785-9
- EC Name:
- Fatty acids, tall-oil, reaction products with boric acid (H3BO3) and diethanolamine
- Cas Number:
- 91770-03-5
- IUPAC Name:
- Fatty acids, tall-oil, reaction products with boric acid (H3BO3) and diethanolamine
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: No data available.
- Age at study initiation: No data available.
- Housing: Stainless steel with elevated wire mesh flooring; 1 rabbit per cage
- Water: Tap water ad libitum
- Acclimation period: acclimated to the laboratory for an appropriate time prior to dosing.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 70 ± 2°F (22°C)
- Humidity (%): 45 ± 5%
- Air changes: controlled environment, but no air change information provided.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: From: 1982-09- 13 To: 1982 -09-20
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Eyes were not rinsed throughout study
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- Six rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not applicable
- Time after start of exposure: Not appliacable
SCORING SYSTEM: Draize method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Conclusions:
- In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation.
- Executive summary:
Test Guidance
Eye irritation study performed by a similar method to 16 CFR 1500.42 of the Federal Hazardous Substances Act,
Method and Material
0.1 mL of the test material was instilled into the right eye of six young adult albino rabbits. The left eye served as the untreated control. The test material was not washed from the eye. Treated eyes were examined at 1, 2, 3, 4 and 7 days following treatment. Interpretation of results was made in accordance with the Draize scale.
Results
No irritation was observed in any animal at any observation period.
Conclusion
In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation.
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