Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Title 21, Code of Federal Regulations, 191.11.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Reaction products of C14-C18 (even numbered) and C14-C18-unsatd. (even numbered) fatty acids or triglycerides with diethanolamine
- Molecular formula:
- not applicable gor UVCB
- IUPAC Name:
- Reaction products of C14-C18 (even numbered) and C14-C18-unsatd. (even numbered) fatty acids or triglycerides with diethanolamine
- Test material form:
- liquid: viscous
- Details on test material:
- see Section 1.2 for detailed composition
Constituent 1
- Reference substance name:
- Amides, C18-unsatd., N,N-bis(hydroxyethyl)
- EC Number:
- 700-972-2
- Molecular formula:
- C22H43NO3
- IUPAC Name:
- Amides, C18-unsatd., N,N-bis(hydroxyethyl)
- Details on test material:
- - Name of test material (as cited in study report): Varamide A-7
- Specific details on test material used for the study:
- The discrepancy between originally usded identifier of the substance and new test material information is due to change in the main identifier through the Substance identity adaptation service offered by ECHA. The new identifier is covered by old identifier mentioned in Additional test material information section
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL or 0.1 g of the undiluted test substance was instilled into one eye of each rabbit. The other eye served as control.
- Concentration (if solution): 100% (undiluted) - Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- 24, 48, 72 h and 7 and 14 d.
- Number of animals or in vitro replicates:
- Six
- Details on study design:
- 0.1 mL or 0.1 g of the undiluted test substance was instilled into the one eye of each animal, and the other eye served as control. The eyes were evaluated for damage to cornea, iris and bulbar and palpebral conjunctivae at 24, 48 and 72 h and 7 and 14 d after instillation. Any residue of the test substance and accumulated discharge are flushed from the eye each time they are scored.
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 11.33
- Reversibility:
- not specified
- Irritation parameter:
- maximum mean total score (MMTS)
- Remarks:
- :Undiluted test substance
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 7.67
- Reversibility:
- not specified
- Irritation parameter:
- maximum mean total score (MMTS)
- Remarks:
- :Undiluted test substance
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 5.67
- Reversibility:
- not specified
- Irritation parameter:
- maximum mean total score (MMTS)
- Remarks:
- :Undiluted test substance
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 3.33
- Reversibility:
- not specified
- Irritation parameter:
- maximum mean total score (MMTS)
- Remarks:
- :Undiluted test substance
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 2.33
- Reversibility:
- not specified
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the test conditions, the undiluted test substance can be assessed to be a irritating to eyes.
- Executive summary:
The ocular irritation potential of the test substance was investigated using New Zealand white rabbits in accordance with Title 21, Code of Federal Regulations, 191.11. The substance (0.1 mL or 0.1 g) was instilled into one eye of each of six rabbits; the other eye served as control. The eyes were evaluated for damage to cornea, iris and conjunctivae at 24, 48, 72 h, then 7 and 14 d. Irritation response in the conjunctiva was observed in terms of redness, chemosis and discharge. The mean conjunctival redness score was 2 in 4/6 animals. The mean irritation score of 11.33, 7.67, 5.67, 3.33 and 2.33 was observed after 24, 48 and 72 h, then 7 and 14 d. Except for conjunctival redness, which was the most prominent response and was present in 3/6 animals, irritation in the remaining eye (chemosis and discharge) reduced to almost 0 by Day 14. Under the conditions of the study, the undiluted test substance was irritating to eyes (Casey, 1976).
Reference
Constituent 1
Test animals / tissue source
Test system
Results and discussion
In vivo
Resultsopen allclose all
Applicant's summary and conclusion
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