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Toxicological information

Skin irritation / corrosion

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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:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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.