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
Study period:
not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, near guideline study, published in peer reviewed literature, limitations in design and/or reporting but otherwise adequate for assessment.
Justification for type of information:
N/A

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1962

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
Single oral dose followed by 14 day observation period.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
m-xylene
EC Number:
203-576-3
EC Name:
m-xylene
Cas Number:
108-38-3
Molecular formula:
C8H10
IUPAC Name:
m-xylene
Details on test material:
no further details
Specific details on test material used for the study:
not specified

Test animals

Species:
rat
Strain:
other: Carworth-Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
Age: 4-5 weeks. Body weight: 90-120 g. Non-fasted.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Single dose
Doses:
Logarithmic differing by a factor of 2 (no further details)
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
Duration of observation period following administration: 14 days.
Statistics:
Oral LD50 (and its fiducial range) estimated. Methods used are not detailed (probit analysis assumed).

Results and discussion

Preliminary study:
not specified
Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
6 631 mg/kg bw
Based on:
test mat.
95% CL:
5 366 - 8 196
Remarks on result:
other: 7.71 mL/kg bw and adjusted for density of 0.86
Mortality:
not specified
Clinical signs:
other: other: not specified
Gross pathology:
not specified
Other findings:
N/A

Any other information on results incl. tables

N/A

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 of m-xylene in male rats was 6602 mg/kg.
Executive summary:

The acute oral LD50 of m-xylene in male rats was 7.71 mL/kg bodyweight (95% CI = 6.24-9.53 mL/kg bw) equivalent to 6602 mg/kg.