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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
3-hydroxy-1,1-dimethylbutyl 2-ethyl-2-methylheptaneperoxoate
EC Number:
EC Name:
3-hydroxy-1,1-dimethylbutyl 2-ethyl-2-methylheptaneperoxoate
Cas Number:
Molecular formula:
4-hydroxy-2-methylpentan-2-yl 2-ethyl-2-methylheptaneperoxoate
Details on test material:
- Batch number: sample no.1
- Purity: 90.5 %
- Before the treatment, the test substance was stored at -20°C and protected from light and was stored at +4 °C during the treatment

Test animals

Details on test animals or test system and environmental conditions:
- Source: Iffa Credo (69210 L'Arbresle, France)
- Age: 8 weeks
- Weight at study initiation: 271 ± 7 g (males) and 230 ± 4 g (females)
- Upon their arrival at C.I.T., the animals were acclimatized to the experimental environment for at least 5 days during which they were observed daily.
On the first day of treatment, the adult animals were approximately 8 weeks old, and had a mean weight of 271 ± 7 g for the males and 230 ± 4 g for the females.
- They were individually identified by earmarks or earnotches.

- Temperature : 22 ± 3°C
- Humidity : 50 ± 20% relative humidity
- Light/dark cycle: 12 hours of light/12 hours of dark
- The air was non-recycled and filtered by absolute filters.
- Food and water: ad libidum

Administration / exposure

Type of coverage:
other: none
Details on dermal exposure:
- Area covered: approximately 10%
- Exposure: semi-occlusive
- Concentration in vehicle: undiluted
- Total volume applied: according to the body weight determined on the day of treatment and test substance specific gravity (0.96)
- Removal of test substance: no
- Exposure duration: 24 hours
- Post-dose observation period: 14 days
- The day before treatment, the dorsal area of each animal was clipped with an electric clipper on an area of 6 x 8 cm. Only animals with healthy intact skin were used for the study.
- A hydrophilic gauze patch was applied to the skin
- The test substance and the gauze patch were held in contact with the skin for 24 hours by means of an adhesive hypoallergic aerated semi-occlusive dressing attached to a restraining bandage. This dressing prevented the ingestion of the test substance by the animal. No residual test substance was observed at removal of the dressing.
Duration of exposure:
24 hours
2000 mg/kg
No. of animals per sex per dose:
- Number of animals: 5 males + 5 females
Control animals:
Details on study design:
- Clinical signs: examined at least once a day
- Mortality: recorded at least twice a day
- Body weight: measured just before administration then on days 5, 8 and 15.
- Necropsy: . macroscopic examination of the main organs: digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities.
- Microscopic examination: no, due to the absence of macroscopic lesions

Results and discussion

Effect levels
Dose descriptor:
Effect level:
>= 2 000 mg/kg bw
No deaths occurred during the observation period.
Clinical signs:
other: No clinical signs were observed during the study.
Other findings:
NECROPSY FINDINGS: No apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Migrated information
The LD0 of the test substance administered by dermal route in rats was higher than 2000 mg/kg. No signs of toxicity were observed at this dose level.
Executive summary:

In an acute toxicity test by dermal route (OECD 402, GLP), the test substance was applied in its original form directly to the skin of 10 Sprague-Dawley rats (5 males and 5 females) at a dose level of 2000 mg/kg, taking into consideration that the specific gravity (SG) of the test substance was 0.96. After 24 hours under a semi-occlusive dressing, no residual test substance was observed.

The mortality, general behaviour and body weight gain of the animals were observed for a period of 14 days after the single application of the test substance. A necropsy was performed on each animal sacrificed at the end of the study.

The general behaviour and body weight gain of the animals were not influenced by the treatment. No deaths occurred at the dose level of 2000 mg/kg.

The macroscopic examination revealed no abnormalities in the animals sacrificed at the end of the study.