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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to Guideline study with acceptable restrictions (partly limited documentation, e.g. no further details on the test substance or onset of clinical symptoms; max technical feasible concentration used [limit concentration according to OECD 403 is 5 mg/l; minor restriction]).

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 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
monomethylformamide
IUPAC Name:
monomethylformamide
Details on test material:
Purity: 99.7%
no further details

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Source: Firma WIGA, Sulzfeld,
Initial body weight: 200 +- 30g
After exposure certified diet and tap water ad libitum
no further details

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose/head only
Vehicle:
other: air
Details on inhalation exposure:
Aerosol generation:
Constant supply of the liquid test substance to a nozzle via an infusion pump and generation of aerosol via compressed air (2.5 bar) which was fed to the nozzle. Inhalation system fed with the aerosol (slight over-pressure of 1 Pa).
Samples (3 l/minutes, total volume 5 l; near the head of animals) analysed by GC methods. Data of 4 samples were given (mean value in the result section)
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
Nominal 24.1 mg/l
Analytical value (mean): 4.1 mg/l
No. of animals per sex per dose:
10
Control animals:
other: not required
Details on study design:
Post exposure observation period 14 days
Clinical symptoms recorded daily
Body weight measured day 0, 7, 14
Necropsy performed
Statistics:
not required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4.1 mg/L air
Exp. duration:
4 h
Mortality:
0/10 females and 0/10 males
Clinical signs:
other: watery or bloody secretion from the nose increased respiration rate ruffled coat prone position all effects reversible within 6 days
Body weight:
clearly reduced body weight gain in males, slight reduction in females
Gross pathology:
no effects
Other findings:
no

Applicant's summary and conclusion

Conclusions:
The LC50 (4 h) in male and female Sprague-Dawley rats is > 4.1 mg/l (1670 ppm).
Executive summary:

omparable to Guideline study with acceptable restrictions (partly limited documentation, e.g. no further details on the test substance or onset of clinical symptoms; max technical feasible concentration used [limit concentration according to OECD 403 is 5 mg/l; minor restriction]).

Ten female and 10 male Sprague-Dawley rats were exposed to an aerosol for 4 h (head only exposure), the analytical concentration was 4.1 mg/l (nominal 24.1 mg/l). Body weight was measured at day 0, 7, and 14. The clinical symptoms were recorded daily. After the post exposure period of 14 days the rats were necropsied.

No mortality was found. Authors reported watery or bloody secretion from the nose, increased respiration rate, ruffled coat, and prone position. All effects were reversible within 6 days. Clearly reduced body weight gain was seen in males, slight reduction in females. No effects were detected at necropsy.

Conclusion: The LC50 (4 h) in male and female Sprague-Dawley rats is > 4.1 mg/l (1670 ppm).

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