Everzol Red CDN Crude

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:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Test guideline 3

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 information

Constituent 1

Test material form:

solid: particulate/powder

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

Results

Results 1

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

Results 2

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	700^1			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.