Captan

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 July 1991 to 30 August 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

1984

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Captan

EC Number:

205-087-0

EC Name:

Captan

Cas Number:

133-06-2

Molecular formula:

C9H8Cl3NO2S

IUPAC Name:

2-[(trichloromethyl)sulfanyl]-2,3,3a,4,7,7a-hexahydro-1H-isoindole-1,3-dione

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

- Batch no.: 4102
- Date received: 9 July 1991
- Description: white powder
- Storage conditions: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The animals were housed In groups of five by sex in solid-floor polypropylene cages with sawdust bedding. With the exception of an overnight fast immediately before dosing and for approximately two hours after dosing, free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Mitham, Essex, U.K.) was allowed throughout the study. The animal room was maintained at a temperature of 20 - 23°C and relative humidity of 48 - 61%. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

For the purpose of the study the test material was freshly prepared, as required, as a suspension at the appropriate concentration in distllled water. All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume adminlstered to each animal was calculated according to Its fasted bodywelght at the time of dosing.

Doses:

A group of ten rats (five males and five females) was dosed as follows: 2000 mg/kg (Dose Level), 200 mg/ml (Concentration), 10 ml/kg (Dose Volume)

No. of animals per sex per dose:

One group of five male and five female rats, 10 animals/dose

Control animals:

no

Details on study design:

RANGE-FINDING STUDY: A range-finding study was performed to establish a dosing reglme as follows:A group of two rats (one male and one female) was dosed as follows: 2000 mg/kg (Dose Level), 200 mg/ml (Concentration), 10 ml/kg (Dose Volume).Deaths and overt signs of toxicity were recorded 1, 2 and 4 hours after dosing and then dally for five days. Indlvidual bodywelghts were recorded on the day of dosing to allow calculatlon of indlvidual treatment volumes. No necropsles were performed. All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume adminlstered to each animal was calculated according to Its fasted bodywelght at the time of dosing.
MAIN STUDY: Individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14. At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological exaralnation. This conslsted of an external examination and opening of the abdominal and thoracic cavities, The appearance of any macroscopic abnormalities was recorded. No tissues were retalned.
EVALUATION OF DATA: Data evaluations included the relationship, if any, between the animals' exposure to the test material and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects.Using the mortality data obtained, an estlmate of the acute oral medlan lethal dose (LD50) of the test material was made.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test material was made.

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systemic toxicity were noted during the study.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of captan in rat is greater than 2000 mg/kg bw in both males and females. In accordance with the provisions of regulation 1272/2008, Annex I, 3.1, it is proposed classification is not required.

Executive summary:

The study was performed to assess the acute oral toxicity of captan in the Sprague-Dawley strain rat. The method used followed OECD Guidelines No. 401 "Acute Oral Toxicity" referenced as Method B1 in the regulation 440/2008. Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material, as a suspension in distilled water at a dose level of 2000 mg/kg bodyweight.

The animals were observed for fourteen days after the day of dosing and were then killed for gross pathological examination.

There were no deaths. No signs of systemic toxicity were noted during the study. All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be higher than 2000 mg/kg bodyweight.