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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye 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 the information in the report is limited. 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, 405, Acute Eye 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 / tissue source

Species:
rabbit
Strain:
other: Japanese white
Details on test animals or tissues and environmental conditions:
Four healthy male albino rabbits, 2.1-2.3kg, 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

Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye was used as the control and treated with 0.1 ml saline
Amount / concentration applied:
0.1 gram
Duration of treatment / exposure:
0.1 g was put in the left eye of the rabbits at the start of the study
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
4
Details on study design:
Animals were examined ophthalmoscopically and evaluated with sodium fluorescein prior to the exposure to assure that they were free of
ocular defects, lesions, or irritation that may have interfered with the goals ofthe test.
0.lg test substance was put into the conjunctival sac of the left eye of each test rabbit (4 rabbits). The eye-lids were then gently keep closed.
The eyes were not washed within 24 hours after exposure. The right eye treated with 0.1 ml normal saline and served as control.
The eye reactions, including those of cornea, iris, and conjunctiva, were evaluated at 1, 24, 48 and 72h after exposure, respectively. One drop
of 5% sodium fluorescein solution was instilled into both eyes of each rabbit for evaluation areas of the cornea opacity. At the same time, all
scorings were taken. The irritation intensity of 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:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No eye reactions occurred after exposure until 72h. The Index of Acute Ocular Irritation (I.A.O.I.) was "0", which was classified to non-irritation.
Other effects:
At necropsy, no effects were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Not irritating to the eye
Executive summary:

The potential of a,a,a',a'-tetramethyl-m-xylene-a,a'-diol to induce ocular irritation was evaluated in rabbits according to OECD guideline.

Four healthy Japanese white rabbits were taken for the test. 0.1 g of the test substance was put into the left eye of four healthy rabbits. The right eye was treated with 0.1 ml normal saline and served as control.  The right/left eye was not treated and served as control. The eyes were not rinsed after administration of the test item. Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration.

No eye reactions occurred after exposure until the 72 h. Therefore the rabbits were not observed anymore.

In conclusion, under these experimental conditions, the test item is not irritant when administered by ocular route to rabbits.