Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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: Non-guideline, non-GLP, animal experimental study, published in peer-reviewed literature. Pre-dates implementation of GLP and guideline but otherwise acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
The joint toxic action of perchloroethylene with benzene or toluene in rats
Author:
Withey RJ and Hall JW
Year:
1975
Bibliographic source:
Toxicology 4, 5-15

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Toluene
EC Number:
203-625-9
EC Name:
Toluene
Cas Number:
108-88-3
Molecular formula:
C7H8
IUPAC Name:
toluene

Test animals

Species:
rat
Strain:
other: Sprague-Dawley Cobb
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Canadian Breeding Farms, St. Constante, Quebec, Canada
- Weight at study initiation: 150-200 g
- Fasting period before study: overnight prior to dosing
- Housing: individually
- Diet: rat pelleted diet ad libitum
- Water: ad libitum
- Acclimation period: one week

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
Dose levels selected based on the results of a pilot study
Doses:
5 dose levels; 4000, 4560, 5200, 5930, or 6760 mg/kg
No. of animals per sex per dose:
20 males
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: observed three times daily, weighed prior to the day of dosing
- Necropsy of survivors performed: yes
Statistics:
LD50's were estimated by the method of probit analysis. The analysis included a goodness of fit test to ensure that the probit model was applicable.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
5 580 mg/kg bw
95% CL:
5 300 - 5 910
Remarks on result:
other: death within 36 hours of dosing and neurotoxic effects at high doses
Mortality:
The majority of deaths occurred 24-36 hours after dosing.
Clinical signs:
other: Rats dosed at high levels with toluene exhibited hind-limb paralysis and petechial bleeding, especially from the urinary tract, eyes and nose.
Gross pathology:
Epithelial cells of the stomach lining were stripped and mild acute gastritis was observed in the glandular portion.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information
Conclusions:
The LD50 of toluene, calculated by probit analysis, was 5580 mg/kg to male rats.