Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study. According to OECD TG 403 no full study with three dose levels required because there were no mortalities in the Limit Test at a 5.2 mg/l.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl formate
EC Number:
203-481-7
EC Name:
Methyl formate
Cas Number:
107-31-3
Molecular formula:
C₂H₄O₂
IUPAC Name:
methyl formate
Details on test material:
- Test substance: Methylformiat
- Analytical purity: 98 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:  MUS RATTUS, Brunnthal.
- Weight at study initiation:  males: 187 g, females: 188 g.
- Fasting period before study:
- Housing:  in groups of 5 animals in wire mesh cages
- Diet: ad libitum, Herilan MRH, H. Eggersmann KG, Rinteln, Germany
- Water: ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Details on inhalation exposure:
- Exposure System: whole-body exposure. 
- Inhalation exposure chamber: glass-steel construction, volume 200 litres.
- Exposure: cages with 5 animals each were placed into the inhalation chamber.
- Duration of exposure period: 4 h. 
- Atmosphere generation: continuous delivery of test substance using an infusion pump to an all-glass evaporator heated to 75°C.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Analytical method: gas chromatography, following sampling in 2-propanol.
Duration of exposure:
4 h
Concentrations:
5.19 mg/l
No. of animals per sex per dose:
20
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on days 0, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Statistics:
Statistical evaluation: using the binominal test described by Wittig (1974).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.2 mg/L air
Exp. duration:
4 h
Mortality:
No mortalities in the male (0/10) or female (0/10) group within the 14-d observation period.
Clinical signs:
other: Discharge of the conjunctivae during exposure, unkempt fur thereafter, forced breathing. No symptoms were seen the second day following exposure.
Body weight:
There was no difference between male and female treated and control groups regarding body weight and body weight gain at 7 and 14 days post treatment.
Gross pathology:
No findings in sacrificed animals.

Any other information on results incl. tables

Mean analytical concentration of TS: 5.19 mg/l.

Applicant's summary and conclusion