2,2-dimethyl-1,3-propanediyl didecanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

13 - 27 Aug 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The analytical purity of the test substance was not specified. Body weight changes could not be not examined.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dimethyl-1,3-propanediyl didecanoate

EC Number:

248-688-3

EC Name:

2,2-dimethyl-1,3-propanediyl didecanoate

Cas Number:

27841-06-1

Molecular formula:

C25H48O4

IUPAC Name:

3-(decanoyloxy)-2,2-dimethylpropyl decanoate

Test animals

Species:

mouse

Strain:

CD-1

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Wilmington, USA
- Age at study initiation: adult animals
- Fasting period before study: animals were fasted 4 h prior to administration
- Housing: 5 animals of the same sex per cage, in stainless steel wire mesh cages
- Diet: Wayne Lab BloxR, ad libitum
- Water: tap water, ad libitum (analyses performed)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5.5 mL/kg

CLASS METHOD
- Rationale for the selection of the starting dose: upon sponsor's request

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 1 and 4 h after dosing (clinical signs, CNS effects and mortality) and daily for the rest of the observation period. Body weights were recorded at study initiation.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the observation period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Necropsy revealed no substance-related findings.

Other findings:

Poor grooming was observed.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.