N-methylformamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is comparable to OECD Guideline 401 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; results presented only for males and females combined).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

monomethylformamide

IUPAC Name:

monomethylformamide

Details on test material:

no further details

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source: SPF-Zucht der Firma Gassner, Sulzfeld, Germany
certified diet and water ad libitum
No further details.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

concentration in test solution 20% at dose levels between 1600 and 2500 mg/kg bw; concentration 30% for >= 3200 mg/kg bw; no data about fasting prior to application.

Doses:

1600, 2000, 2500, 3200, 4000, 5000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations:daily
- weighing: no data
- Necropsy of survivors and rats found dead

Statistics:

LD50 calculated according to LITCHFIELD and WILCOXON.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 000 mg/kg bw

95% CL:

2 460 - 3 660

Remarks on result:

other: for males and females combined

Mortality:

Data on mortality are presented in the Table below. At the high dose levels rats died within 7 days and in a few cases also in the 2nd week.

Clinical signs:

other: Clinical signs: apathy, poor general condition, red encrusted noses; no effects seen in survivors after 6-12 days

Gross pathology:

Surviving rats: no treatment related effects.
Rats found dead: no treatment related effects.

Other findings:

no data

Any other information on results incl. tables

Acute toxicity in rats after oral application of monomethylformamide

Dose in mg/kg bw	Number of rats which died within
	1 hour	24 hours	48 hours	7 days	14 days
5000	0/10	0/10	0/10	5/10	8/10
4000	0/10	0/10	0/10	5/10	6/10
3200	0/10	0/10	0/10	1/10	7/10
2500	0/10	0/10	0/10	1/10	2/10
2000	0/10	0/10	0/10	0/10	0/10
1600	0/10	0/10	0/10	0/10	0/10

Applicant's summary and conclusion

Conclusions:

The oral LD50 is 3000 mg/kg bw in male and female rats combined.

Executive summary:

The study is comparable to OECD Guideline 401 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; results presented only for males and females combined).

Groups of 5 male and 5 female rats were gavaged with 20 -30% aqueous solutions at dose levels of 1600, 2000, 2500, 3200, 4000, 5000 mg/kg bw. The post exposure observation period was 14 days. At the high dose levels rats died within 7 days and in a few cases also in the 2nd week.Clinical signs like apathy, poor general condition, and red encrusted noses occurred; no effects were seen in survivors after 6 -12 days. Necropsy revealed no treatment related effects.

Conclusion: The oral LD50 is 3000 mg/kg bw in male and female rats combined.