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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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
The study has some deviations and some information in the report is incomplete. However, it appears the study was conducted in accordance with current guidelines.
- The laboratory has no GLP accreditation. However the report includes a QA certification and guideline compliance statement.
- It is not mentioned if water/diet is analyzed for contaminants.
- The animals should be observed up to 14 days after removal of the patches, the total observation period was 72 hours.
GLP compliance:
no
Remarks:
The study was conducted in China for a Chinese registration. The laboratory has no GLP accreditation. However the report includes a QA certification and guideline compliance statement.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: α,α,α',α'-tetramethyl-m-xylene-α,α'-diol
Lot No.: 101155
odourless white solid

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

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24-48-72 hours
Score:
0
Remarks on result:
other: No effects observed
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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not irritating to skin
Executive summary:

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 the method in the "The Guidelines for the Testing of Chemicals" 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. According to "The Guidelines for the Hazard Evaluation of New Chemical Substances", a,a,a',a'-tetramethyl-m-xylene-a,a'-diol belongs to non-irritation for rabbits' skin.