Registration Dossier
Registration Dossier
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EC number: 483-940-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From January 29, 2008 to May 07, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Principles of method if other than guideline:
- - Japanese Ministry of Agriculture, Forestry and Fisheries
(JMAFF), 12 Nousan, Notification No 8147, November 2000,
including the most recent partial revisions. - GLP compliance:
- yes
Test material
- 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:
- - Source: Harlan, Horst, The Netherlands
- Weight at study initiation: at least 1.0 kg
- Housing: individually in labeled cages with perforated floors
- Water: ad libitum
- Acclimation period: at least 5 days
- Temperature (°C): 21.0 ± 3.0 °C
- Humidity (%): 30-70 %
- Photoperiod: 12hrs dark / 12hrs light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- Elix, Millipore S.A.S., Molsheim, France
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 0.5 g test article was moistened with 0.5 mL water
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- three
- Details on study design:
- - Area of exposure: the skin of one flank
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 700, 727 and 730
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 700, 727 and 730
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Table 1. Individual skin irritation scores
Animal |
7001 |
727 |
730 |
||||||
Time after exposure |
Erythema |
Oedema |
comments |
Erythema |
Oedema |
comments |
Erythema |
Oedema |
comments |
1 hour |
－ |
0 |
a |
－ |
0 |
a |
－ |
0 |
a |
24 hours |
0 |
0 |
a |
0 |
0 |
a |
0 |
0 |
a |
48 hours |
0 |
0 |
a |
0 |
0 |
a |
0 |
0 |
a |
72 hours |
0 |
0 |
a |
0 |
0 |
a |
0 |
0 |
a |
1Sentinel.
Comments:
－ No scoring possible due to red/purple staining
a Red/purple staining of the skin by the test substance
Table 2. Mean value irritation scores
Animal |
Mean 24, 48 and 72 hrs |
|
Erythema |
Oedema |
|
700 |
0 |
0 |
727 |
0 |
0 |
730 |
0 |
0 |
Table 3. Animal specifications
Animal |
Sex |
Age at start (weeks) |
Body weight (g) |
|
prior to application |
at termination |
|||
700 |
♂ |
8-10 |
1931 |
2067 |
727 |
♂ |
7-9 |
1271 |
1360 |
730 |
♂ |
7-9 |
1309 |
1429 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 404, EU Method B.4, EPA OPPTS 870.2500 and JMAFF test method test method, Everzol Red CDN Crude was non-irritant to skin. Therefore, Everzol Red CDN Crude was not met a category based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the NOTOX Study Plan for 487477. Three rabbits were exposed to 0.5 g of Everzol Red CDN Crude, moistened with 0.5 mL water, by application onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure. No symptom of systemic toxicity were observed in the animals during the test period and no mortality occurred. All animals was no formation of erythema andoedemaon the test area within 72 hours after patch removal. On the basis of the test results given above, the response of Everzol Red CDN Crudewas categorized as non-irritant.
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