Registration Dossier
Registration Dossier
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EC number: 806-731-9 | CAS number: 1428353-74-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 12, 2015 to September 23, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.89
- Reversibility:
- other:
- Remarks:
- Slight erythema was present in one animal throughout the study period. Erythema reversed in remaining two animals by day 14
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Reversibility:
- other:
- Remarks:
- Not present in 2 animals. Did not reverse in one animal through study period of 21 days.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Primary Irritation Index (PII) for SP5076 was 1.8. The Draize scores at 24, 48, and72 hours after patch removal for erythema and edema for individual animals were:Erythema:Animal 1 (24, 48, 72 hr): 1, 2, 2Animal 2 (24, 48, 72 hr): 2, 2, 2Animal 3 (24, 48, 72 hr): 2, 2, 2EdemaAnimal 1 (24, 48, 72 hr): 0, 0, 0Animal 2 (24, 48, 72 hr): 0, 0, 1Animal 3 (24, 48, 72 hr): 0, 0, 0
- Executive summary:
The substance resulted in a 24 -72 hr mean erythema and edeam score of 1.89 and 0.06, respecitively and does not meet the CLP criteria for classification as a skin irritant. This was a GLP OECD 404 guideline study. There were no deaths or remarkable body weight changes noted during the study. All 3 rabbits had very slight erythema to slight erythema, and only 1 of these rabbits had very slight to slight edema. While erythema had resolved by study day 14 for 2 of the rabbits, very slight erythema and slight edema were still present at the last observation period (study day 21) for the remaining rabbit. The only other dermal finding was desquamation on study day 14 for 2 rabbits.
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