tert-butyl peroxypivalate

Repeated dose toxicity: inhalation

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:

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

Test material information

Constituent 1

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

additive 1

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

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.