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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-butyl 3,5,5-trimethylperoxyhexanoate
EC Number:
236-050-7
EC Name:
tert-butyl 3,5,5-trimethylperoxyhexanoate
Cas Number:
13122-18-4
Molecular formula:
C13H26O3
IUPAC Name:
tert-butyl 3,5,5-trimethylhexaneperoxoate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Central Institute for the Breeding of Laboratory Animals TNO, Zeist, The Netherlands
- Age at study initiation: Young adult
- Weight at study initiation: Males: about 235 g, females: about 160 g
- Housing: stainless steel/ glass exposure chamber; five male and five female rats in separate wire screen cages

Administration / exposure

Route of administration:
inhalation: mist
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: stainless steel/ glass aerodynamic nozzle nebulizer
- Exposure chamber volume: 1.5 m3
- Airflow rate: 3 m3/ h

TEST ATMOSPHERE
- Brief description of analytical method used: Samples of the atmosphere were drawn through a Bergshoeff air-sampler filled with xylene and subsequently analysed by gas-liquid chromatography with the aid of an Intersmat gaschromatograph with a QF-1 (4.8% diglycerol on a chromosorb G-AW-DMCS) stainless-steel column.
- Samples taken from breathing zone: yes
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
4 h
Concentrations:
No data
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: no
Statistics:
not performed

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.8 mg/L air
Exp. duration:
4 h
Mortality:
No mortality occurred
Other findings:
During the first half hour of the exposure period the rats were somewhat restless. This symptom gradually disappeared and after one hour all rats were asleep. This situation continued throughout the remainder of the exposure period.
Since no mortality occurred during the 4 hours of the exposure and the subsequent observation period, the 4 hour LC 50 could not be determined.

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
The results of the present acute inhalation study lead to the conclusion that the 4-hour LC 50 of tert-Butylperoxy-3,5,5-trimethylhexanoat is higher than 0.8 mg/L of air.
Executive summary:

The acute inhalation toxicity of tert-Butylperoxy-3,5,5-trimethylhexanoat was studied by exposing rats for 4 hours to an aerosol of the undiluted substance at a concentration of 0.8 mg/L of air.

No mortality occurred and no signs of intoxication were observed.

It was concluded that the 4 -hour LC 50 of tert-butyl 3,5,5-trimethylperoxyhexanoate was higher than 0.8 mg/L of air.