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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to Guideline study with acceptable restrictions (no details about the test substance; only 2 dose levels tested [at least 3 recommended], post exposure period 7 [low dose] and 12 days [high dose]).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal 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 details

Test animals

Species:
rabbit
Strain:
Vienna White
Sex:
male/female
Details on test animals or test system and environmental conditions:
Source: M.GAUKLER, Offenbach, Germany
only healthy animals (no skin lesions)
Mean initial weight of males: 2.3 kg; females 2.6 kg
Certified diet and tap water ad libitum
no further details

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Fur removed by clipping 15-24 h prior to application.
Exposure area appr. 220 cm²
After application test area covered by inert foil plus fixation via bandage.
After 24 h exposure test site washed with luke warm water and dried.
Duration of exposure:
24 h
Doses:
400 or 2000 mg/kg bw
No. of animals per sex per dose:
5 at 2000 mg/kg bw and 10 at 400 mg/kg bw
Control animals:
not required
Details on study design:
Clinical signs and local effects recorded (no details about frequency).
No data about body weight.
Post exposure period 12 days (high dose) or 7 days (low dose).
Necropsy performed.
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 289 mg/kg bw
Remarks on result:
other: Probitanalysis according to Finney
Mortality:
Data on mortality are presented in the Table below. At the low dose 2 females died due to pneumonia; these deaths might be not treatment related (not discussed by the authors). Lethal effects mainly within 48 h after application.
Clinical signs:
other: 2000 mg/kg bw: apathy, increased respiration rate, tremor, convulsions. No effects found 8 days after application. 400 mg/kg bw: no symptoms.
Gross pathology:
Animals found dead: acute dilatation of the heart, hyperemia, liver lobules greyish.
Survivors: no treatment related effects.
Other findings:
Local effects:
400 & 2000 mg/kg bw: slight reddening which was reversible within the post exposure observation period

Any other information on results incl. tables

Mortality in rabbits after acute dermal exposure to N-methylformamide

Dose in mg/kg bw

Mortality within

1 h

24 h

48 h

7 days

12 days

2000

0/5m 0/5f

0/5m 0/5f

1/5m 4/5f

1/5m 4/5f

2/5m 4/5f

400

0/10m 1/10f

1/10m 2/10f*

1/10m 2/10f*

1/10m 2/10f*

No data

m: males; f: females

*: animals died due to pneumonia

Applicant's summary and conclusion

Conclusions:
The dermale LD50 in rabbits was 1289 mg/kg bw for males and females combined, as there are no indications for gender-specific differences in susceptibility.
Executive summary:

Comparable to Guideline study with acceptable restrictions (no details about the test substance; only 2 dose levels tested [at least 3 recommended], post exposure period 7 [low dose] and 12 days [high dose]).

Five male and 5 female White Vienna rabbits received dermal applications of 2000 mg/kg bw undiluted test substance (occlusive, exposure period 24 h followed by washing; post exposure period 12 days). Using the same experimental design but 7 days post exposure period a lower dose of 400 mg/kg bw was tested in 10 males and 10 females. Animals died within 48 h after application (with one exception at the high dose level, died within 12 days). No clinical signs were detected at the low dose. At 2000 mg/kg bw apathy, increased respiration rate, tremor, and convulsions were observed. Local effects were restricted to a slight reddening which was reversible. Necropsy revealed not treatment related effects in survivors but dilatation of the heart, hyperemia and greyish liver lobules in animals found dead. Two rabbits of the low dose group died due to pneumonia (probably not treatment related).

Conclusion: The dermale LD50 in rabbit was 1289 mg/kg bw for males and females combined, as there are no indications for gender-specific differences in susceptibility.