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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:
other: Study well documented, following official guidelines, GLP compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Three New Zealand white rabbits were supplied by Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U.K. At the start of the study the animals weighed 2.49 - 2.78 kg and were approximately twelve to sixteen weeks old. After a minimum acclimatisation period
of five days each animal was given a number unique within the study written on the inner sunface of the ear and on a cage label using a black indelible marker pen.
The animals were individually housed in suspended metal cages. Free access to mains drinking water and food ( Rabbi t Diet, Special Diet Services Limited, Witham, Essex, U.K. ) was allowed throughout the study.

The animal room was maintained at a temperature of 19-23 °C and relative humidity of 50 - 60 %. The rate of air exchange was approximately 15 changes per hour and the Iighting was controlled by a time switch to give 12 hours light and 12 hours darkness.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Amount / concentration applied:
A quantity of 0.5 g of the test material moistened with 0.5 ml of distiIIed water
Duration of treatment / exposure:
4h
Details on study design:
Approximately twenty-four hours prior to the commencement of the test, each of a group of three rabbits was prepared by closely cìipping the fur from the dorsal/flank areas using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.

The moistened sample was introduced under a 2.5 cm x 2.5 cm gauze patch and placed in position on the shorn skin. The patch was secured in
position over the test material with two lengths of adhesive strapping (SLEEK) in the form of a cross. To prevent the animals from interfering with the patches the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP ) and the animals were returned to their cages for the duration of
the exposure period.

Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water followed by ether. Approximately one hour following removal of the patches , and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale i.e. Draize score.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72h mean value
Score:
ca. 0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72h mean value
Score:
ca. 0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72h mean value
Score:
ca. 0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72h mean value
Score:
ca. 0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72h mean value
Score:
ca. 0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72h mean value
Score:
ca. 0.3
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
No erythema or edema was noted at any test site one hour after removal of the patches. Two of the three test sites continued to show no irritation throughout the study period. Very slight erythema was noted at one treated skin site at the 24-hour observation; no irritation was noted at subsequent
observations. AlI treated skin sites showed faint yelIow staining one to 48 hours aften treatment. This did not affect assessment of skin reactions.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information according to CLP Regulation Criteria used for interpretation of results: EU
Conclusions:
The substance was tested for skin irritation potential following OECD 404. Under the experimental conditions no skin irritation was observed.
Executive summary:

The substance was tested for skin irritation potential following OECD 404. Three New Zealand White Rabbits were exposed to a semi-occlusive patch containing the moistened substance for an exposure period of 4 h on a clipped skin. Readings for edema and erythema were perfomed at 24, 48 and 72 h with mean values below 0.3 for each animal. Under the experimental conditions no skin irritation was observed and the substance is not classified as skin irritant.