tert-pentyl 2-ethylperoxyhexanoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 2a Guideline study without detailed documentations (no certificat of analysis for example)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

tert-pentyl 2-ethylperoxyhexanoate

EC Number:

211-687-3

EC Name:

tert-pentyl 2-ethylperoxyhexanoate

Cas Number:

686-31-7

Molecular formula:

C13H26O3

IUPAC Name:

2-methylbutan-2-yl 2-ethylhexaneperoxoate

Test material form:

not specified

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Acllimation periode: 5 days
- Housing: individually- Food and water ad libidum
- Identification:ear tags and cage cards

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

- The back of the animals were clipped free of furw ith electrical clipper on about 30 % of the body surface.
- On the day of the exposure, abrasion of the exposure site was performed for 3 males and 2 females. The abrasions were minor incisions that were not sufficient deep to disturb the derma or induce a bleeding

Duration of exposure:

24 hours, then the exposure site was gently weaped with clean gauze

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Observations for mortality, clinical signs, local reactions, and toxicological findings were recorded for a total of 14 days.
Body weight were recorded on the inital day of dosing, at day 8, and at study termination

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: Diarrhea, digestivetroubles, several days after dosing, for some animals.

Gross pathology:

Not performed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD0 of tert-butyl peroxyoctoate is more than 2000 mg/kg in New Zealand White rabbits.

Executive summary:

 The acute oral toxicity of tert-amyl peroxyoctoate was evaluated in a limit test in rats according to a procedure similar to OECD N°402 guideline (Acute Toxic Standard Method) and in compliance with GLP. 5 male and 5 female New Zealand rabbits were given a single dermal dose (2000 mg/kg) of tert-amyl peroxyoctoate. Following treatment, rabbits were observed daily and weighted at termination. No gross necropsy examination was performed since no mortality occured and since few clinical signs were observed (especially digestive troubles).

  

Under these experimental conditions, the oral LD0 of tert-butyl peroxyoctoate is more than 2000 mg/kg in New Zealand White rabbits.