Registration Dossier
Registration Dossier
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EC number: 806-731-9 | CAS number: 1428353-74-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 17, 2016 to May 4, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Coconut oil, reaction products with boric acid (H3BO3), diethanolamine and glycerol
- EC Number:
- 806-731-9
- Cas Number:
- 1428353-74-5
- Molecular formula:
- Substance is a UVCB.
- IUPAC Name:
- Coconut oil, reaction products with boric acid (H3BO3), diethanolamine and glycerol
- Test material form:
- other: liquid
- Details on test material:
- Identification: TS13001Physical state/Appearance:amber colored liquidExpiry Date: 30 January 2015Storage Conditions:room temperature in the darkIntended use/Application: Lubricating oil additive
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- study period (unwashed)
- Observation period (in vivo):
- 17 days
- Duration of post- treatment incubation (in vitro):
- unwashed
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Reversibility:
- fully reversible within: 7 days
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- The 24-, 48-, and 72-hour post-instillation Draize scores for SP5076 were 18.7/110, 17.0/110, and 17.7/110, respectively. All positive ocular irritation subsided by study day 14.
- Executive summary:
In a GLP guideline study, the substance caused irritation that meets the CLP criteria for classification as category 2A. There were no deaths or remarkable body weight changes noted during the study. The only clinical observations noted during the study were ocular-related and consisted mainly of partial and/or complete closure of the right eye. Positive corneal irritation, conjunctival irritation, and iridal irritation were noted for all rabbits. Iridal and corneal irritation subsided by study day 4 and 14, respectively. Positive conjunctival irritation subsided by study day 7; however, conjunctival redness did not subside until study day 17. Clear discharge was noted in all 3 rabbits and subsided by 72 hours post-instillation. Two of 3 rabbits had some fluorescein staining noted at 24 hours post-instillation which subsided by study day 4.
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