m-(1-cyanoethyl)benzoic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 17 December 199 to 28 june 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to international guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: E.E.C. 92/69 - Annex V - method B3 (1992) - 93/21 (1993)

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

m-(1-cyanoethyl)benzoic acid

EC Number:

226-897-0

EC Name:

m-(1-cyanoethyl)benzoic acid

Cas Number:

5537-71-3

Molecular formula:

C10H9NO2

IUPAC Name:

3-(1-cyanoethyl)benzoic acid

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

. Identification : Carboxyphenyl propionitrlle (CAPRIL)
. Identification for the study : 07651 A4 009
. Presentation : fine brown-yellow powder
. Purity : 85.9 %
. Batch number (reference) : 9318400
. Packaging : brown glass container
. Quantity received : about 50 g
. Date of receipt : 4 January 1994
. Storage : room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Number and sex :
. minimum of 4 males, 4 females (preliminary study);
. 5 males, 5 females (limit test study);
. 20 to 30 males, 20 to 30 females (main study).

- Age at initiation of treatment : adult 7 to 9 weeks old.
- Body weight range at initiation of treatment : males and females : 200 to 300 g

ENVIRONMENT AND HUSBANDRY
- Housing : In an air-conditioned building (building L2):
. Temperature : 19 to 25°C (target values).
. Relative humidity : 30 to 70 % R.H. (target values).
. Air changes : minimum 8 air changes per hour.
. Lighting cycle : 12 hours light (artificial)/12 hours dark.

- Caging : animals housed individually in polycorbonote cages type Fl (305 x 180 x 184 mm).
- Bedding : dust-tree sawdust made from spruce tree wood, analysed twice a year for chemical and bacterial contaminants.

DIET AND WATER
- Diet : pelleted complete Diet, ad libitum (rat-mouse Diet reference AO4 C10. Usine d'Alimentotlon Rationnelle. Villemoisson s/Orge, France), sterilised by Irradiation and analysed for the absence of chemical and bacteriological contaminants.
- Water : filtered (0.2 µm) mains drinking water, ad libitum analysed twice a year for chemicals and bacterial contamination (Service d'Hygiene et de Sante de la vllle de Lyon, France).
- Contaminants : no contaminants are known to be present in the diet or water at levels which might interfere with achieving the objective of the study.

PRE-TREATMENT PROCEDURES
- Animal health procedure : clinical Inspection for ill-health on arrival and then just before the beginning of treatment.
- Acclimatisation period: 5 days minimum between animal arrival and start of treatment.
- Allocation to treatment group : if appropriate, performed during the acclimatisation period, using a body weight range procedure.
Mean body weights of each group will not be statistically significantly different from each other (Student't test), each sex being considered separately.
- Weight variation not to exceed for each sex ± 20 % of the mean weight.
- Identification of the animals : ear notches.
- Identification of the cages : colour coded label with study number, group number, sex and animal numbers, code number of the test article, the starting date of the test.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Remarks:

The test article was applied once only under the form of a paste at 91 % (W/V) in water for injection

Duration of exposure:

24h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Details on study design:

PRELIMINARY STUDY:
The animals will be observed for 7 days. Only mortality will be expressed. Necropsy will not be performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Mortality occurred 1 hour after the treatment (one male).

Clinical signs:

other: There were no changes In behaviour or clinical signs in any of the treated animals during the observation period. The local tolerance of the test article was good: no cutaneous lesion (erythema or oedema) was noted to the application site of the test arti

Gross pathology:

There were no macroscopic findings that could be associated with treatment.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD 50, by the cutaneous route, in the rat (male + female) > 2000 mg/kg.