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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:
supporting study
Study period:
1970
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: no GLP study; no guideline was followed

Data source

Reference
Reference Type:
publication
Title:
The subacute inhalation toxicity of 109 industrial chemicals
Author:
J.C. Gage
Year:
1970
Bibliographic source:
Brit. J. industr. Med., 1970, 27, 1-18

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Repeated dose inhalation toxicity study in rats using a fixed dose of the test item.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Analytical purity: 33% (w/w) in white spirit

Test animals

Species:
other: specific-pathogen-free rats
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Alderley Park, Macclesfield, Cheshire
- Weight at study initiation: 200 g
- Fasting period before study: no
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
air
Remarks on MMAD:
MMAD / GSD: no data
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: glass desiccator
- Method of holding animals in test chamber: wire mesh partitions to separate animals
- Source and rate of air: The air was filtered, dried to a relative humidity of less than 10%, and supplied at a line pressure of 1 atm
- Method of conditioning air: dynamic atmosphere
- System of generating particulates/aerosols: A vapour concentration by injecting a liquid at a known rate into a metered stream of air by means of a controlled fluid-feed atomizer

TEST ATMOSPHERE
- Brief description of analytical method used: no
- Samples taken from breathing zone: no

VEHICLE
- Composition of vehicle: air
Analytical verification of doses or concentrations:
no
Details on analytical verification of doses or concentrations:
no data
Duration of treatment / exposure:
28 days
Frequency of treatment:
20 x 6 hours
Doses / concentrations
Remarks:
Doses / Concentrations:
50 ppm
Basis:
nominal conc.
No. of animals per sex per dose:
2
Control animals:
yes, historical
Details on study design:
no data

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: throughout the study

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: at the end of the study

BODY WEIGHT: Yes
- Time schedule for examinations: each morning

URINALYSIS: Yes
- Time schedule for collection of urine: overnight after the last exposure day
- Metabolism cages used for collection of urine: Yes
- Animals fasted: No
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
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:
no effects observed
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

Effect levels

Dose descriptor:
NOEC
Effect level:
50 ppm
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: = 0.36 mg/L

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Rats exposed to a test item concentration of 50 ppm for 5 days a week for 28 days showed no mortality and no clinical signs or adverse effects on gross pathology and histopathology.