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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
IN accordance with standard draize methodology but conducted before OECD test guidelines and GLP were introduced
GLP compliance:
no
Remarks:
Study conducted before GLP was introduced

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
none given

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Albino rabbits of approximatley 2 kg were used.
No other information on husbandry or environmental conditions is available.

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
100mg
Duration of treatment / exposure:
1 hr
Observation period (in vivo):
7 days or as long as injury persists
Number of animals or in vitro replicates:
a minimum of three animals
Details on study design:
The day before the application of test material the eyes are stained with one
drop of a 5% aqueous solution of sodium fluorescein. The stain
is washed out of the eye after 10 seconds and the cornea is then
examined for existing lesions. Any rabbit showing an abnormality
is discarded.
The test material {l00mg or 0.lml) is instilled into the
lower lid of one eye, and then both lids are held together for a
few seconds. The rabbit is restrained in stocks for the next hour.
The eyes are examined and the degree of irritation assessed
1, 24 and 72 hours, and 7 days after application, or as long as
injury persists, by comparison of the test eye with the control
untreated eye. Fluorescein is applied after land 24 hours, but
at subsequent examinations only when an opacity was present on
the previous occasion. The grading of the irritation is based on
modifications of the method of Draize et al (!) and takes account
of the degree of oedema and redness of the bulbar and palpebral
conjunctivae, the quantity of any discharge, the reaction of the
iris to a light source, and the density and area of any opacity of
the cornea. Each test compound is administered to a minimum of
three rabbits.

Results and discussion

In vivo

Results
Irritation parameter:
other: qualitative description
Basis:
other: qualitative description
Time point:
other: maximum of 7 days
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The conclusion of the study was negligible irritation, having effects on the conjunctiva only.