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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other company data
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:
other: JMAFF Guidelines (2000) including the most recent partial revisions.
Qualifier:
according to
Guideline:
other: - United States Environmental Protection Agency (EPA). Health Effects Test Guidelines, OPPTS 870.2500, Acute Dermal Irritation. Office of Prevention, Pesticides and Toxic Substances (7101), EPA 712-C-98-196, August 1998, Acute Dermal Irritation.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Vehicle:
water
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Other effects:
Brown/orange staining of the treated skin by the test substance was observed throughout the observation period, which did not hamper the scoring of the skin reactions.

No remnants of the test substance were present on the skin

Any other information on results incl. tables

Summary from report of the skin irritation
Primary skin irritation/ corrosion study with Everzol Orange ED-G Crude in the rabbit ( 4hr semi-occlusive application). Three rabbits were exposed to 0.5 grams of Everzol Orange ED-G 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 skin irritation was caused by 4 hours exposure to Everzol Orange ED-G Crude. Brown/orange staining of the treated skin by the test substance was observed throughout the observation period, which did not hamper the scoring of the skin reactions. No remnants of the test substance were present on the skin. Based on these results, Everzol Orange ED-G Crude does not have to be classified and has no obligatory labeling requirement for skin irritation according to GHS and EC 67/548/EEC.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met