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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From April 27 to 30, 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3,3'-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]bis[propiononitrile]
EC Number:
223-765-4
EC Name:
3,3'-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]bis[propiononitrile]
Cas Number:
4058-30-4
Molecular formula:
C18H15ClN6O2
IUPAC Name:
3,3'-({4-[(2-chloro-4-nitrophenyl)diazenyl]phenyl}imino)dipropanenitrile
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST SYSTEM
- Species: Albino Rabbit, New Zealand White, (SPF-Quality)
- Original Source: Broekman Institute, Someren, The Netherlands
- Selection of animals: Healthy animals, not previously used, were selected prior to treatment. Both flanks of each animal were free of interfering lesions, irritation or defects.
- Total number of animals: 3 male rabbits
- Allocation and age at start of treatment: Animals 1248, 1249 & 1254; approx. 12 weeks
- Identification: Ear tag.
- Acclimatisation: At least five days after veterinary examination.

HUSBANDRY
- Room No.: Animal 1254 was housed in room 11 during acclimatisation, but was moved to room 10 at day -1 (one day before treatment). Animals 1248 and 1249 were housed in room 10 during acclimatisation. All animals were housed in room 10 during the observation period of the study.
- Conditions: Standard Laboratory Conditions. Air-conditioned with 15 air changes per hour and controlled environment with optimal conditions considered as being a temperature of 21°C and a relative humidity of 55%. Fluctuations from these optimal conditions were noted, but were considered not to have affected study integrity. Lighting was 12 hours artificial fluorescent light and 12 hours dark per day. Music during the light period.
- Accommodation: Individually in labelled cages with perforated floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
- Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands) approx. 100 gram per day.
this report.
- Water: Free access to tap-water diluted with decalcified water.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TREATMENT
Approximately 24 hours before treatment, the dorsal fur was shaved with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm2). Prior to test substance administration, the animals were physically examined and the shaved area of skin to be treated was normal.
On test day 1, 0.5 gram of the test substance was applied to the intact skin of the shaved area on one flank, using a Scotchpak-non-woven patch (2x3 cm, 3M,
St.Paul, U.S.A.) mounted on Micropore tape (3M, St. Paul, U.S.A.). The contralateral flank was similarly prepared (but without test substance) to act as a procedural control. The dressing was wrapped around the abdomen and secured with an elastic bandage (Coban, 3M, St. Paul, U.S.A.).
Four hours after the application, the dressing was removed and the remaining test substance removed using a tissue moistened with tap-water and subsequently a dry tissue.
The skin areas concerned of the animals were re-shaved at least 3 hours before the observations, when considered necessary to facilitate scoring.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Other effects:
COLOURATION
Red staining of the treated skin by the test substance was observed during the observation period. The staining did not interfere with the scoring of the erythema.
BODY WEIGHTS
The body weights and variability in body weight gain of the animals were considered to be normal.
TOXICITY SYMPTOMS / MORTALITY
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance did not cause any signs of irritation on rabbit skin. The substance is not classifiable according to GHS criteria.
Executive summary:

Method

The Skin irritation was determined in an irritation test on rabbits according to the OECD Guideline 404 and the EU Method B.4.

Observations

The test substance was applied onto shaved skin of three male albino rabbits using semi-occlusive dressings for 4 hours, followed by four observations at approximately 1, 24, 48 and 72 hours days after removal of the dressings and remaining test substance. Under the conditions of this study, no skin irritation was caused by the test substance and no corrosive effect occurred on the skin in any of the three rabbits. In the area of application, red staining of the treated skin was observed, which did not interfere with the scoring of erythema. No signs of systemic intoxication were observed during the study period. The test substance resulted in a primary irritation index of 0.0 (non-irritating) when applied to the intact rabbit skin.

 

Result

Not irritant.