trans-dichloroethylene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Data taken from accepted publication with limited details on methods and results. This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference

Reference Type:

publication

Title:

The acute and subchronic toxicity in rats of trans-1,2-dichloroethylene in drinking water

Author:

Hayes JR, Condie LW Jr, Egle JL Jr and Borzelleca JF

Year:

1987

Bibliographic source:

J. Am. Coll. Toxicol., 6:471-478

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

yes

Remarks:

dose levels not reported

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

trans-dichloroethylene

EC Number:

205-860-2

EC Name:

trans-dichloroethylene

Cas Number:

156-60-5

Molecular formula:

C2H2Cl2

IUPAC Name:

(1E)-1,2-dichloroethene

Details on test material:

- Purity: 98%

Test animals

Species:

rat

Strain:

other: Sprague-Dawley derived CD, Charles River

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 22-30 days
- Weight at study initiation: Male and female rats, weighing 113 ± 5 g and 102 ± 2 g, respectively
- Fasting period before study: fasted overnight (water but no feed, 16 hours) before dosing
- Housing: stainless steel wire-bottomed suspended cages
- Diet: Purina Rodent Chow No. 5001, ad libitum
- Water: ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24°C
- Humidity (%): 40-60%
- Photoperiod (hrs dark / hrs light): 12-hour light-dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 450-850 mg/mL

MAXIMUM DOSE VOLUME APPLIED: volume of solution administered was 10 mL/kg

Doses:

not reported

No. of animals per sex per dose:

five dosage groups consisting of 10 rats per sex per group

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Hourly observations were made during the first 9 hours after administration, followed by twice daily (at least 5 hours apart) observations for the next 14 days.
- Necropsy of survivors performed: yes

Statistics:

The LD50 was determined by the method of Litchfield and Wilcoxon.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

7 902 mg/kg bw

Based on:

test mat.

95% CL:

6 805 - 9 175

Remarks on result:

other: Dose-dependent central nervous system depression, ataxia, and depressed respiration observed at all doses

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

9 939 mg/kg bw

Based on:

test mat.

95% CL:

6 494 - 15 213

Remarks on result:

other: Dose-dependent central nervous system depression, ataxia, and depressed respiration observed at all doses

Mortality:

All deaths occurred within 30 hours after dosing.

Clinical signs:

other: Central nervous system depression, ataxia, and depressed respiration were observed at all doses; the severity was dose dependent.

Gross pathology:

Gross necropsy findings of all rats that died were essentially negative. No consistent compound-related gross pathological findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

This study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
LD50 Male Rats = 7902 mg/kg
LD50 Female Rats = 9939 mg/kg

Executive summary:

To determine the LD₅₀ in rats, the test item was administered by gavage to male and female Sprague-Dawley derived Charles River rats. Male and female rats were divided into five dosage groups consisting of 10 rats per sex per group. After administration, hourly observations were made during the first 9 hours then followed by twice daily (at least 5 hours apart) observations for the next 14 days. All deaths occurred within 30 hours after dosing. Central nervous system depression, ataxia, and depressed respiration were observed at all doses; the severity was dose dependent. Gross necropsy findings of all rats that died were essentially negative. No consistent compound-related gross pathological findings were observed at necropsy. The LD₅₀s for male and female rats were 7902 and 9939 mg/kg, respectively.