1,1,4,4-tetramethylbutane-1,4-diyl bis(2-ethylperoxyhexanoate)

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was performed pre-GLP and no guideline is mentioned. Very limited data is provided on the methods and results, only a 2 page summary. No data on test substance composition or purity. Full evaluation of the validity of this study is not possible.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

no guideline followed

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,5-Dimethyl-2,5-bis (2-ethylhexanoyl peroxy)-hexane

IUPAC Name:

2,5-Dimethyl-2,5-bis (2-ethylhexanoyl peroxy)-hexane

Details on test material:

No further information.

Test animals

Species:

rat

Strain:

other: Charles River CD strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River
- Age at study initiation: no data
- Weight at study initiation: 218 to 264 grams
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

whole body

Vehicle:

not specified

Details on inhalation exposure:

No data

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Concentrations:

100, 200, 400, 800 mg/L

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were made during exposure and daily afterwards, the bodyweight of the animals was determined pre-exposure and at the termination of the study.
- Necropsy of survivors performed: no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

>= 800 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

1 females died at 800 mg/L

Clinical signs:

other: See table

Body weight:

A decrease in bodyweight gain was noted during the study.

Gross pathology:

The female rat which died at the 800 mg/L exposure level had moderately congested lungs and focal congestion of the glandular mucosa of the stomach.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

The acute inhalation (LC50) value in male and female albino rats would be greater than 800 mg/L

Executive summary:

Twenty male and 20 female albino rats of the Charles River CD strain, weighing 218 to 264 grams, were divided equally into 4 dosage groups. Each group of rats was placed in a sealed 59.1 litre glass chamber and exposed to the appropriate level, 100, 200, 400 or 800 mg/L, of test material for 4 hours.

Observations for pharmacodynamic signs and mortality were made during the exposure and daily for 14 days. 1 female died at 800 mg/L. The acute inhalation (LC50) value in male and female albino rats would be greater than 800 mg/L