Reaction mass of N,N-dimethylformamide and N,N-dimethylformamide hydrochloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Referenced source in an international report.

Data source

Reference

Reference Type:

review article or handbook

Title:

Dimethylformamide, SIDS Initial Assessment Report For SIAM 13

Author:

OECD

Year:

2001

Bibliographic source:

UNEP PUBLICATIONS

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

no further details

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dimethylformamide

EC Number:

200-679-5

EC Name:

N,N-dimethylformamide

Cas Number:

68-12-2

Molecular formula:

C3H7NO

IUPAC Name:

N,N-dimethylformamide

Test material form:

not specified

Details on test material:

purity: > 99.9%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Mortality and signs of toxicity were recorded 1, 24 and 48 hours and 7 days after the substance administration.

Doses:

1520, 1900, 2375, 3040 and 3800 mg/kg for 10 rats per group
6016 mg/kg for 5 rats per group

No. of animals per sex per dose:

10 Sprague-Dawley rats per group at the dose levels of 1520, 1900, 2375, 3040 and 3800 mg/kg and to 5 rats per group at 6016 mg/kg.

Control animals:

not specified

Details on study design:

Mortality and signs of toxicity were recorded 1, 24 and 48 hours and 7 days after the substance administration. Animals that died were necropsied and the surviving animals were sacrificed and necropsied after the 7-day post observation period.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 040 mg/kg bw

Based on:

test mat.

Mortality:

48 h after substance application one animal each at both highest dose levels (6080 and 3800 mg/kg) died. After 7 days all animals were dead at 6080 mg/kg, 5 of 10 rats were dead at 3800 mg/kg and 6 of 10 rats at 3040 mg/kg. There were no dead animals at 2375 mg/kg and 2 of 10 and 1 of 10 rats were dead after 7 days at 1900 and at 1520 mg/kg, respectively.

Clinical signs:

other: At necropsy of animals that died and those sacrificed at the end of the study, discolored livers were seen. In relation to the dose administered the main symptoms observed were apathy and staggering.

Applicant's summary and conclusion

Conclusions:

DMF is of low acute toxicity in rats: LD50 oral in rats is 3040 mg/kg bw.