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

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

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

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

Details on test material:

purity: 99.7%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

not specified

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

2.23, 4.92, 5.10 and 5.85 mg/L

No. of animals per sex per dose:

10 animals per sex per dose

Control animals:

yes

Details on study design:

After the 4 h DMF-exposure, the animals were examined for 14 days. Body weight was determined before the beginning of the study, after 7 days during the study and at the end of the post observation period. The animals were daily observed for clinical signs and mortality. Animals that died during the study and the
surviving animals sacrificed at the end of the post observation period were necropsied and macroscopically examined.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.85 mg/L air (analytical)

Based on:

not specified

Exp. duration:

4 h

Mortality:

Deaths occurred 3 days after the start of the study; at 4.92 mg/l 2 of 10 males and 1 of 10 females died, at 5.1 mg/l all animals survived treatment and at 5.85 mg/l 3 of 10 males and no female animal died.

Clinical signs:

other: At the analytical concentration of 2.23 mg/L all animals survived and did not show any clinical signs related to DMF exposure. In the other three treatment groups dyspnoea (irregular or intermittent respiration) and rough fur were observed as well as in 3

Gross pathology:

Surviving animals recovered 6-7 days after exposure. These animals did not show any gross lesions at necropsy, whereas the animals that died during the study had some organ findings, e.g. discoloration of the liver, hemorrhage in thymus and punctate hemorrhage in pancreas and in the gastric mucous membrane.

Applicant's summary and conclusion

Conclusions:

The LC50 by inhalation route for an exposure duration of 4h was found > 5.85 mg/L for male and female rats.