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Registration Dossier
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EC number: 272-789-1 | CAS number: 68911-83-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Well documented non-GLP study according to Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38, No. 187, p 27019, 27 September 1973 and according to a method similar to OECD Guideline 404 with some deviations: occlusive dressing, intact and abraded skin, no scoring data available at 48 hours.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38, No. 187, p 27019, 27 September 1973
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive dressing, intact and abraded skin, no scoring data available at 48 hours
- GLP compliance:
- no
Test material
- Reference substance name:
- Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine
- EC Number:
- 272-789-1
- EC Name:
- Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine
- Cas Number:
- 68911-83-1
- Molecular formula:
- C40H76N2O
- IUPAC Name:
- Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine
- Details on test material:
- - Name of test material (as cited in study report): 46C
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: One side of the animals' backs was abraded at one site with a lancet sufficiently deep to penetrate the stratum corneum by not enter the derma to produce bleeding. The skin of the other side was allowed to remain intact.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 24 hours
- Observation period:
- The wrapping was removed at the end of the twenty-four hour period and the treated areas were examined. Readings were also made after seventy-two hours.
- Number of animals:
- Six albino rabbits
- Details on study design:
- TEST SITE
One side of the animals' backs was abraded at one site with a lancet sufficiently deep to penetrate the stratum corneum but not enter the derma to produce bleeding. The skin of the other side was allowed to remain intact. Gauze patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the animals to hold the patches in place.
REMOVAL OF TEST SUBSTANCE
The wrapping was removed at the end of the twenty-four hour period and the treated areas were examined.
SCORING SYSTEM
The Draize method of scoring was employed
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 5
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritant / corrosive response data:
- Erythema score and eschar formation: 24 and 72 hours, intact and abraded skin: 3
Edema formation: 24 and 72 hours, intact and abraded skin: 2
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the criteria of the CLP Regulation, the substance is classified as category 2 skin irritant.
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