[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan to Feb 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

454-800-3

EC Name:

-

Cas Number:

70258-18-3

Molecular formula:

C6H5Cl2N

IUPAC Name:

2-Chloro-5-chloromethylpyridine

Test material form:

solid

Specific details on test material used for the study:

- Stability under test conditions: The formulation was prepared for immediate use and administration was carried out within 1 hour.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Versuchstierzucht Winkelmann, Borchen, Germany
- Age at study initiation: 7-8 weeks (males), 10-11 weeks (females)
- Weight at study initiation: 162-180 g (males), 173-184 g (females)
- Housing: 5 animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): ca. 50
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Doses:

Males: 100, 250, 500, 750, 2000 mg/kg bw
Females: 100, 250, 500 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Administration volume: 5 mL/kg
- Duration of observation period following administration: 14 days
- Frequency of weighing: day 1, 4, 8 and 14
- Necropsy of survivors performed: yes

Statistics:

not specified

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 250 - < 500 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 100 - < 250 mg/kg bw

Based on:

test mat.

Mortality:

Males: After treatment with 100 or 250 mg/kg bw no animals died (0/5). After treatment with 500, 750 or 2000 mg/kg bw all animals died (5/5) within 1 day.
Females: After treatment with 100 mg/kg bw no animals died (0/5). After treatment with 250 or 500 mg/kg bw 4/5 or 5/5 animals died within 5 hours.

Clinical signs:

other: At 250 mg/kg bw and above male and female animals showed the following clinical signs: Apathy, labored breathing, staggering gait, reduced motility, partly abdominal or lateral position, partially low reflexes, lacrimation, closed palpebral fissures, sali

Gross pathology:

In the animals died after administration, the following gross pathological findings were recorded: Lungs blown, partly spotted; spleen pale; liver dark; stomach partly with clear or red fluid; partly in the glandular stomach ulcus-like foci, partly reddened mucous membrane or like corroded looking mucous membranes; intestinal tract filled with clear liquid.

No findings were recorded for the animals killed at the end of the follow-up period.

Other findings:

none specified

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Executive summary:

According to OECD TG 401 the acute oral toxicity (LD50) in rats is in the range of 250 - 500 mg/kg bw for males and in the range of 100 - 250 mg/kg bw for females. Thus, the test substance is proved to be moderately toxic under the described experimental conditions after single oral administration to rats.