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EC number: 213-147-2 | CAS number: 927-07-1
Toxicological information
Repeated dose toxicity: inhalation
Currently viewing:
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:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- The subacute inhalation toxicity of 109 industrial chemicals
- Author:
- J.C. Gage
- Year:
- 1 970
- 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 substance name:
- tert-butyl peroxypivalate
- EC Number:
- 213-147-2
- EC Name:
- tert-butyl peroxypivalate
- Cas Number:
- 927-07-1
- Molecular formula:
- C9H18O3
- IUPAC Name:
- tert-butyl 2,2-dimethylpropaneperoxoate
- Reference substance name:
- 2,2,4,6,6-pentamethylheptane
- EC Number:
- 236-757-0
- EC Name:
- 2,2,4,6,6-pentamethylheptane
- Cas Number:
- 13475-82-6
- Molecular formula:
- C12H26
- IUPAC Name:
- isododecane
- Test material form:
- liquid
Constituent 1
additive 1
Test animals
- Species:
- other: specific-pathogen-free rats
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system 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
- Dose / conc.:
- 50 ppm
- Remarks:
- 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
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
Effect levels
- Key result
- 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
- Key result
- 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.
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