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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
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

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:
Clinical signs: apathy, poor general condition, red encrusted noses; no effects seen in survivors after 6-12 days
Body weight:
No data available
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.

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