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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:
OECD Guideline 405 (Acute Eye 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 study was conducted in accordance with current guidelines and the report includes a QA certification statement.
- It is not mentioned if water/diet is analyzed for contaminants.
- No details on the scoring method "The Index of Acute Ocular Irritation (I.A.O.I.) "
GLP compliance:
no
Remarks:
The study was conducted in China for a Chinese registration. The laboratory has no GLP accreditation. However the study was conducted in accordance with current guidelines and the report includes a QA certification 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 / 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

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1-24-48-72 hours
Score:
0
Remarks on result:
other: No effects were observed
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.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not irritating to the eye
Executive summary:

Four healthy Japanese white rabbits were taken for the test. An eye irritation test was conducted with rabbits to determine the potential ability to produce irritation and corrosion of test substance. O.lg test substance was put into the left eye of four healthy rabbits. The right eye was treated with 0.1 ml normal saline served as control. Eye irritation was evaluated by the methods in "The Guidelines for the Testing of Chemicals" after exposure. No eye reactions occurred after exposure until the 72 h. The Index of Acute Ocular Irritation (I.A.O.I.) 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' eyes.