Registration Dossier
Registration Dossier
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EC number: 235-834-6 | CAS number: 13001-38-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From July 18 to 27, 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Complete read-across justification is attached in section 13. Source study has reliability 1.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Similar Substance 03
- IUPAC Name:
- Similar Substance 03
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: 14 weeks (males), 13 weeks (females)
- Weight at study initiation: 2.4 to 2.7 kg
- Housing: individually in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days under laboratory conditions, after health examination
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 45 - 70 %
- Air changes: 10 - 15 per h
- Photoperiod: 12 h light and 12 h dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g moistened with bi-distilled water - Duration of treatment / exposure:
- 4 hours.
- Observation period:
- Up to 72 hours after treatment.
- Number of animals:
- 2 females and 1 male.
- Details on study design:
- TEST SITE
- Area of exposure: ca. 6 cm2
- Type of coverage: semi-occlusive
- Type of wrap: dressing wrapped around the abdomen and anchored with tape
REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm tap water
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS: 1h, 24 h, 48 h, 72 h
SCORING SYSTEM:
ERYTHEMA AND ESCHAR FORMATION
0 No erythema
1 Very slight erythema
2 Well-defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) or eschar formation (injuries in depth preventing erythema) reading
OEDEMA FORMATION
0 No oedema
1 Very slight oedema (barely perceptible)
2 Slight oedema (edges of area well-defined by definite raising)
3 Moderate oedema (edges raised approximately 1 mm)
4 Severe oedema (raised more than 1 mm and extending beyond the area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Other effects:
- - Mortality/clinical signs: no clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
- Irritation: test article did not elicit any skin reactions at the application site at any of the observation times (all scores 0). The mean values from 24 to 72 hours were therefore 0 for erythema and 0 for oedema.
- Coloration: no staining by the test item of the treated skin was observed.
- Corrosion: no irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
- Body weights: body weights of all rabbits were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- other: Non classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Non irritant to the rabbits skin.
- Executive summary:
Method
Skin irritation study carried out according to OECD guideline 404. Semicocclusive application of 0.5 g of test substance applied on clipped intact skin of 3 rabbits (2 F and 1 M) for 4 hours. Treated skin was washed and observed for signs of oedema and erythema at 1 h, 24 h, 48 h and 72 h.
Results
No signs of skin irritation and no staining were noted.
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