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Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Not standard methodology and inadequate documentation

Data source

Reference
Reference Type:
publication
Title:
Vapor toxicity of 1,1,1-trichloroethane (methyl-chloroform) determined by experiments on laboratory animals
Author:
ADAMS-EM; SPENCER-HC; ROWE-VK; IRISH-DD
Year:
1950
Bibliographic source:
ARCH-IND-HYG-OCCUP-MED 1 225-236

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
basic measurements only following 7 hour daily exposures for 5 days a week
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Redistilled commercial product, source not given.
Purity > 99 % (impurity was 1,2-dichloroethane)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Not specified

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Remarks on MMAD:
MMAD / GSD: not specified
Details on inhalation exposure:
Metal 300-litre box.
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
sample flasks analysed by combustion and titration of inorganic chloride by the Volhard method. All concentrations within 10 % of nominal
Duration of treatment / exposure:
7 hours
Frequency of treatment:
3000 ppm:7 hour daily exposures for 5 days a week (47/48 exposures in 66/67 days)
5000 ppm: 7 hour daily exposures for 5 days a week (31 exposures in 44 days)
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
5000 ppm
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
3000 ppm
Basis:
nominal conc.
No. of animals per sex per dose:
5000 ppm 5 males and 5 females
3000 ppm 6 males and 7 females
Control animals:
yes, concurrent no treatment

Examinations

Observations and examinations performed and frequency:
Body wieght
Sacrifice and pathology:
Blood concentrations of urea nitrogen. Gross necropsy and histopathology of major organs only

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
not specified
Details on results:
Clinical obsercations at 5000 ppm only - slight unsteadines and lethargy.
Slight reduction in body wieght gain in femails exposed to 5000 ppm in first week only (no data - start and terminal weights only)- no overall effect
No effect on final body weight, organ weight, blood cocentrations of urea nitrogen and histopathology

Effect levels

Dose descriptor:
LOEL
Effect level:
ca. 5 000 ppm
Sex:
male/female
Basis for effect level:
other: Reversible clinical signs after 7 hours exposure. No other notable effects. No effects at 3000 ppm

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Following repeated daily exposure of the male and female rat to the vapour (7 hours a day for 31 days over a 44 day period), only reversible clinical signs were observed at 5000 ppm; there were no effects on body weight, necropsy or pathology of major organs. There were no effects at 3000 ppm. 5000 ppm is therefore considered to be the LOEL. This was a none standard experiment, but the results are in a similar region as that reported by other investigators.
Executive summary:

Following repeated daily exposure of the male and female rat to the vapour (7 hours a day for 31 days over a 44 day period), only reversible clinical signs were observed at 5000 ppm; there were no effects on body weight, necropsy or pathology of major organs. There were no effects at 3000 ppm.  5000 ppm is therefore considered to be the LOEL. This was a none standard experiment, but the results are in a similar region as that reported by other investigators.