Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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

Constituent 1
Chemical structure
Reference substance name:
trans-dichloroethylene
EC Number:
205-860-2
EC Name:
trans-dichloroethylene
Cas Number:
156-60-5
Molecular formula:
C2H2Cl2
IUPAC Name:
arsenic
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 levelsopen allclose all
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
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:
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.