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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:
21 June 2011 - 24 June 2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has some deviations and some information in the report is incomplete. However the study was conducted in accordance with current guidelines and the report includes a QA certification statement.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: The Guidelines for the Testing of Chemicals (State Environmental Protection Administration of China, 2004.5, 404, Acute Dermal Irritation Test)
Deviations:
no
GLP compliance:
no
Remarks:
The laboratory has no GLP accreditation (nevertheless the project plan and the report were audited by the Quality Assurance Unit)

Test material

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

Test animals

Species:
rabbit
Strain:
other: Japanese white
Details on test animals and environmental conditions:
Four healthy male albino rabbits, 2.1-2.2kg, were supplied by Beijing KeYu Expenerimental Animals Products Center (Certificate No:
SCXK(Jing)2007 -0003).

Animals were kept in animal room in Institute of Laboratory Animal Sciences, CAMS (normal environment, Certificate No.: SYXK(Jing)
2010-0030). Environmental conditions for animal husbandry are maintained with the 12-h light/dark cycle, the temperature of 20-23°C,
and the relative humidity of 40-70%. All animals had free access to sterilized drinking water and irradiation sterilized commercial pellet diets
except during exposure (Beijing HFK Bio-technology Co., Ltd. Certificate No.: SCXK(Jing) 2009- 0008). The tap water was of drinking
water quality (Sterile water for reverse osmosis).Animals were acclimatized to the laboratory conditions for at least 5d prior to the test.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
water
Controls:
other: The right flank was treated with 0.5 ml distilled water as control
Amount / concentration applied:
0.5 grams
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
4
Details on study design:
24 hours before the test, the fur on the bilateral dorsal sides (3 X 3 cm2) of rabbits was removed by clipping, respectively.
It was treated with 0.5 g substance (moistened with distilled water) on the left skin area evenly at the second day, and covered with one layer of sulfate paper and two layers of surgical bandages, and fixed with non-irritation tapes, The right free fur area was treated with 0.5 ml distilled water as control, the covering was same as the left, The exposure duration was 4 hours.
Afterwards, the dressing was removed and the residual test substance was cleaned with detergent and warm water.
The test areas were evaluated for both erythema and edema, and compared with the control areas, Scores were given at 24, 48 and 72h
following removal of the dressing. The irritation intensity of the test substance was recorded according to the criteria in "The Guidelines for the Testing of Chemicals".



Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No erythema was observed on the treated skin area of any rabbit. There was no erythema on the control area of the rabbits. The average score of skin responses was zero.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions of the test, a,a,a',a'-tetramethyl-m-xylene-a,a'-diol is considered as non-irritant when applied topically to rabbit skin.
Executive summary:

The acute dermal irritation of the meta-diols isomer was evaluated in rabbits according to OECD 404 guideline.

Four healthy Japanese white rabbits were taken for the test. 0.5g test substance was applied to an area of shaved skin on left of back of four healthy rabbits and the application site was covered with a semi-occlusive dressing for four hours. Following exposure, dermal irritation was evaluated by at 24, 48 and 72h after removal of the dressing. No erythema was observed on the treated skin area of any rabbit. There was no erythema on the control area of the rabbits. The average score of skin responses was 0. In conclusion, under the experimental conditions of the test, a,a,a',a'-tetramethyl-m-xylene-a,a'-diol is considered as non-irritant when applied topically to rabbit skin.