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Administrative data

Endpoint:
skin 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).
Deviations:
not specified
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

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
The test was performed on 3 male and 3 female rabbits of the Himalayan breed weighing 1.5 to 2 kg. They were housed individually in metal cages, were kept at a constant room temperature of 18 ± 1°C, at a relative humidity of 55 ± 5 % and on a 14 hours light cycle day. The animals received ad libitum standard rabbit food NAFAG, Gossau SG and water.
Prior to treatment they were adapted to our laboratories for a minimum of 8 days

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
For treatment gauze patches of 2 5 x 2.5 cm with test material were applied to the prepared abraded and non abraded skin, in quantities of 0 1 g.
Duration of treatment / exposure:
72 hours
Observation period:
24 and 72 hours after the application.
Number of animals:
3 male and 3 female
Details on study design:
Two days before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on the left side was slightly scarified.
For treatment gauze patches of 2 5 x 2.5 cm with test material were applied to the prepared abraded and non abraded skin, in quantities of 0 1 g.
The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour exposure.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 72 hours after the treatment
Score:
0.1
Max. score:
1
Reversibility:
fully reversible
Irritant / corrosive response data:
The test material caused therefore a mild skin irritation to rabbits.
Other effects:
none

Any other information on results incl. tables

The primary irritation index is the moan value of the sum of the scores for erythema and edema from all 6 rabbits 24 and 72 hours after initiation of treatment.

The severity of skin irritation was rated as follows:

- mean value of less than 2 indicated mild

- from 2 to 6 moderate

- above 6 severe skin irritation

Applicant's summary and conclusion

Interpretation of results:
other: mild skin irritating to rabbits.
Remarks:
Criteria used for interpretation of results: not specified