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Diss Factsheets

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:
Between 15 January 1985 and 5 February 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study conducted using a method similar to an existing guideline but not complying will aspects of currrent guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: U.S. 40 CFR Section 163.81-5 Federal Register August 22., 1978
Deviations:
not specified
Principles of method if other than guideline:
A group of six rabbits was clipped over a wide area of their backs approximately 24 hours prior to application. The skin remained intact. A dose of 0.5 ml of liquid was applied to the test site. Adjactent areas served as the control. A guaze patch was placed over the treated area and was held in place by a non-irritating tape and then covered by a semi-occullllsive dressing. The wrapping and tape were removed after 4 hours follwed by washing of the site with water. The treated areas were examined for signs of erythema and edema using the Draize method within 30-60 minutes of removal and at 24, 48, and 72 hours.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction product of methylenebis(acrylamide) and (O,O)-diisooctyl dithiophosphoric acid
EC Number:
700-945-5
Molecular formula:
Complex UVCB substance
IUPAC Name:
Reaction product of methylenebis(acrylamide) and (O,O)-diisooctyl dithiophosphoric acid
Test material form:
other: Brown viscous liquid
Details on test material:
Description: Brown viscous liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Animals house in stainless steel cages with elevated wire mesh flooring (1/cage), were acclimated 5 days prior to testing and individually identified by an ear tag. Each cage was identified by a cage card. Husbandry conditions were as follows: Temperature 60 to 75 degrees C Relative Humidity 55+/_ 25% Light 12 hours light/dark cycle diet Wayne 15 % Rabbit Ration and tap water ad libitum.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: adjacent site used as control
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
30-60 minutes and 24, 48, and 72 hours
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 hours
Score:
0.83
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 Hours
Score:
0.5
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 Hours
Score:
0.17
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0.17
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 Hours
Score:
0.83
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 Hours
Score:
0.33
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 Hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 Hours
Score:
0
Max. score:
4
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study this substance does not require classification under EU Regulation (EC) No. 1272/2008 for skin irritation.
Executive summary:

A dose of 0.5 ml was applied to the intact skin of six rabbits; the adjacent skin was used as a control. After 4 hours exposure the guaze, tape, and semi-occulsive bandage were removed. The skin of each animal was evaluated according to the method of Draize within 30 -60 minutes of removal of the bandages and test material with water and at 24, 48, and 72 hours. The mean 24, 48, and 72 hour erythema and edema scores were 0.84 and 0.11, respectively. Erythema showed some evidence of reversibility but was not fully reversible at 72 hours. Edema was fully reversible by 48 hours. Based on the results of this study this substance does not require classification under EU Regulation (EC) No. 1272/2008 for skin irritation.