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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
january 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Contains sufficient detail to suggest GLP-like characteristics even though no statement of certification is reported (reasonably thorough description of authors, dates, design, results, and interpretation).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: "apprisal of the safety of chemicals in foods, drugs and cosmetics (1959), the US Association of food and drug officials (AFDO).
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Propazine
EC Number:
205-359-9
EC Name:
Propazine
Cas Number:
139-40-2
Molecular formula:
C9H16ClN5
IUPAC Name:
6-chloro-N2,N4-bis(propan-2-yl)-1,3,5-triazine-2,4-diamine
Details on test material:
Product designation: propazine
Batch No. 368

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
The test was performed on 3 male and 3 female rabbits of the Himalayan breed weighing 1.5 to 2 kg The animals were housed individually in metal cages, were kept at a constant room temperature of 18 ± 10 °C, at a relative humidity of ± 5 % and on a 14 hour light cycle day. The animals had ad libitum access to standard rabbit food - NAFAG, Gossau SG - and water. Prior to treatment they were adapted to our laboratories for a minimum of 8 days. Only rabbits with normal ophthalmic findings were used for these tests.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye was not treated and served as an untreated control.
Amount / concentration applied:
0.1 g of the test substance was inserted into the conjunctival sac of the left eye of the 6 rabbits.
Duration of treatment / exposure:
7 days
Observation period (in vivo):
1,2,3,4,7 days after the application
Number of animals or in vitro replicates:
3 male and 3 famale
Details on study design:
The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the 6 rabbits and the lids were gently closed for one second. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water The eye irritation was appraised with a slit - lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit.

Results and discussion

In vivo

Results
Irritation parameter:
other: irritation index
Basis:
mean
Time point:
other: 1,2,3,4, 7 days after the treatment
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
The test material caused no eye irritation to rabbits.
Other effects:
none

Any other information on results incl. tables

The primary eye irritation index represents the sum of the mean values for cornea, iris and conjunctivae. this procedure was carried out separately for unrinsed and rinsed eyes respectively.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified