Benzonitrile, 3,3'-(2,3,5,6-tetrahydro-3,6-dioxopyrrolo[3,4-c]pyrrole-1,4-diyl)bis-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-06-24 to 1993-04-08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant Guideline study. Minor deficiency: 1st reading was done after 30 min instead of 60 min. This has no influence on the reliability of the 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:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

adopted Sep. 19, 1984

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

412-640-1

EC Name:

-

Cas Number:

84632-50-8

Molecular formula:

C20 H10 N4 O2

IUPAC Name:

3-[4-(3-cyanophenyl)-3,6-dioxo-2H,3H,5H,6H-pyrrolo[3,4-c]pyrrol-1-yl]benzonitrile

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

orange powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: 12 to 14 weeks
- Weight at study initiation: 2.7 to 3.1 kg
- Housing: individually in metal cages with perforated floors
- Diet: standard laboratory diet SDS Stanrab (P) Rabbit Diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: yes, duration not specified

ENVIRONMENTAL CONDITIONS
- Temperature: approximately 19°C
- Humidity: 30 - 70%
- Air changes: approximately 19 per hour
- Photoperiod: 12 hours artificial light (0700 - 1900 hours) in each 24-hour period

IN-LIFE DATES: From: 1993-02-09 To: 1993-02-12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: electric clippers

Vehicle:

water

Remarks:

distilled

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g per animal
- Concentration: 50% w/v

VEHICLE
- Amount applied: 0.5 mL distilled water

Duration of treatment / exposure:

4 hours

Observation period:

approximately 0.5, 24, 48 and 72 hours after exposure

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 100 mm x 100 mm (% not specified, but approximately 10% of the total body surface)
- Type of wrap if used: gauze pad covered with "Elastoplast" elastic adhesive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: the treated area of skin was washed with warm (30° to 40°C) water and blotted dry with absorbent paper
- Time after start of exposure: at the end of the 4 hours exposure period

SCORING SYSTEM:
Erythema/eschar and oedema formation: (scoring 0 - 4), according to OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

all animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

No dermal response to treatment was observed in any animal throughout the observation period.

Other effects:

There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU