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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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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.