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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study design similar to current OECD guideline, but no results for individual animals reported, short reporting.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
refer to "Principles of method"
Principles of method if other than guideline:
Rats were given single doses of 2,4-Xylidine in water solutions by stomach tubes. Deaths were recorded for animals expiring within 14 days after administration of the substances. An approximate LD50 value was obtained using a few animals. Accurate values were then determined using the approximate LD50 value as the intermediate dosage in a series of three levels at 10 antilog unit intervals with 10 animals at each level. Calculations of LD50 were made using the Bliss probit method.
GLP compliance:
no
Remarks:
study performed before GLP guidelines
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,4-xylidine
EC Number:
202-440-0
EC Name:
2,4-xylidine
Cas Number:
95-68-1
Molecular formula:
C8H11N
IUPAC Name:
2,4-dimethylaniline
Details on test material:
The test materials were prepared from commercial aromatic amine-free bases (K&K Laboratories, Jamaica, N.Y.)

Test animals

Species:
rat
Strain:
Osborne-Mendel
Sex:
male
Details on test animals or test system and environmental conditions:
- Weight at study initiation: 250 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Male Osborn-Mendel rats (250 g) were given single doses of 2,4-Xylidine in water solutions by stomach tubes. Deaths were recorded for animals expiring within 14 days after administration of the substances. An approximate LD50 value was obtained using a few animals. Accurate values were then determined using the approximate LD50 value as the intermediate dosage in a series of three levels at 10 antilog unit intervals with 10 animals at each level. Calculations of LD50 were made using the Bliss probit method.
Doses:
- an approx. LD50 was obtained with 2,4-Xylidine using a few animals
- accurate values were then determined in each case, using the approximaate LD50 value as the intermediate dosage in a series of three levels at 10 antilog unit intervals with 10 animals at each level
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- an approx. LD50 was obtained with each compound using a few animals
- accurate values were then determined in each case, using the approximaate LD50 value as the intermediate dosage in a series of three levels at 10 antilog unit intervals with 10 animals at each level
Statistics:
- calculations of LD50 were made using the Bliss probit method

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
1 259 mg/kg bw
Remarks on result:
other: LD50 as hydrochloride
Mortality:
no data
Clinical signs:
other: no data
Gross pathology:
no data
Other findings:
no data

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Due to the LD50 of 1259 mg/kg bw the test item has to be classified as Xn, R 22; H302 - Harmful if swallowed.
Executive summary:

Due to the LD50 of 1259 mg/kg bw the test item has to be classified as Xn, R 22;

H302 - Harmful if swallowed.