3-(2-{4-[2-(4-cyanophenyl)vinyl]phenyl}vinyl)benzonitrile

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-(2-{4-[2-(4-cyanophenyl)vinyl]phenyl}vinyl)benzonitrile

EC Number:

419-060-8

EC Name:

3-(2-{4-[2-(4-cyanophenyl)vinyl]phenyl}vinyl)benzonitrile

Cas Number:

79026-02-1

Molecular formula:

Hill formula: C24 H16 N2 CAS formula: C24 H16 N2

IUPAC Name:

4-(2-{4-[2-(3-cyanophenyl)ethenyl]phenyl}ethenyl)benzonitrile

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Test animals

Species:

rat

Strain:

other: Hanlbm: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Wölferstrasse 4, CH-4414 Füllinsdorf / Switzerland
- Age at study initiation: Males: 8-10 weeks; Females: 10-12 weeks
- Weight at study initiation: Males: 255.9 - 273.3 g; Females: 189.8 - 205.4 g
- Housing: During acclimatization in groups of five in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz) during treatment and observation.
- Diet (e.g. ad libitum): Pelleted standard Kliba 3433, batch no.03/00 rat maintenance diet (Kliba Mühlen AG, CH-4303 Kaiseraugst) available ad libitum. Results of analyses for contaminants are archived at RCC Ltd, Itingen.
- Water (e.g., ad libitum): Community tap water from Füllinsdorf, available ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Acclimation period: One week under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23.5
- Humidity (%): 39-57
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12-hour artificial fluorescent light, 12-hour dark cycle.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: Polyethylene glycol 300 (PEG 300)

Details on dermal exposure:

TEST SITE
- % coverage: 10 %
- Type of wrap if used: The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done):Twenty-four hours after the application the dressing was removed and the skin was flushed with lukewarm tap water and dried with disposable paper towels. Thereafter, the skin reaction of the application sites were assessed.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,mortality

Statistics:

The toxicity was estimated without the use of a statistical method.

Results and discussion

Preliminary study:

None

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No systemic or local signs of toxicity were observed during the study period.

Gross pathology:

No macroscopic findings were observed at necropsy.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

The median lethal dose of FAT 60253/A after single dermal administration to rats of both sexes, observed over a period of 14 days is:
LD50 (rat): greater than 2000 mg/kg body weight

Executive summary:

A group of five male and five female Hanlbm: WIST (SPF) rats was treated with FAT 60253/A at 2000 mg/kg by dermal application. The test item was diluted in vehicle (polyethylene glycol, PEG 300) at a concentration of 0.4 g/ml and administered at a volume of 5 ml/kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded together with clinical signs at the same time intervals on test day 1 and then twice daily on test days 2-15. Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically. No deaths occurred during the study. No clinical signs were observed during the observation period. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. The median lethal dose of FAT 60253/A after single dermal administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat): greater than 2000 mg/kg body weight.