Registration Dossier
Registration Dossier
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EC number: 203-894-2 | CAS number: 111-67-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-12-13 to 1995-12-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it was carried out according to Guidelines (EPA 798.4470, OECD 404, 92/69/EEC B.4 and MAFF 59 NohSan No. 4200) and was GLP compliant.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
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:
- Reference substance 001
- Cas Number:
- 111-66-0
- Molecular formula:
- C8H16
- Details on test material:
- - Name of test material (as cited in study report): Gulftene 8
- Substance type: C8 alpha olefin
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 millilitre
- Concentration (if solution): Not reported - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 6 (5 males, 1 female)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal: Mean of animals (1-6)
- Time point:
- 24/48/72 h
- Score:
- ca. 3.42
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal: Mean of animals (1-6)
- Time point:
- 24/48/72 h
- Score:
- 1.9
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal: Mean of animals (1-6)
- Time point:
- 24/48/72 h
- Score:
- 1.1
- Reversibility:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating according to EU CLP classification
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test material application produced a primary irritation index of 3.42 calculated according to US EPA FIFRA guidelines, and mean scores of 1.9 for erythema/eschar formation and 1.1 for edema according to EU labelling restrictions. Compound-induced corrosion was not reported.
- Executive summary:
In a primary dermal irritation study, 5 male and 1 female New Zealand White rabbits were dermally exposed to 0.5 millilitre of Gulftene 8 for 4 hours. Animals then were observed for 14 days and irritation was scored by the Draize method.
The test material application produced a primary irritation index of 3.42 calculated according to US EPA FIFRA guidelines, and mean scores of 1.9 for erythema/eschar formation and 1.1 for edema according to EU labelling restrictions. Compound-induced corrosion was not reported.
This study received a Klimisch score of 1 and is classified as reliable without restriction because it was carried out according to Guidelines (EPA 798.4470, OECD 404, 92/69/EEC B.4 and MAFF 59 NohSan No. 4200) and was GLP compliant.
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