Reaction mass of 3-(octanoyloxy)propyl decanoate and propane-1,3-diyl didecanoate and propane-1,3-diyl dioctanoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

Updated Guideline adopted February 1987

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

C8-10-1,3-Butandiolester

Molecular formula:

Not available, UVCB

IUPAC Name:

C8-10-1,3-Butandiolester

Test animals

Species:

rat

Strain:

other: Bor: WISW (SPF Cpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, D-W-4799 Borchen
- Weight at study initiation: 200 - 300 g
- Fasting period before study: no
- Housing: Singly in type III Makrolon cages
- Diet: ad libitum, Ssniff R 10 complete feed for rats, supplied by Ssniff Spezialfutter GmbH, D-W-4770 Soest
- Water: Drinking water ad libitum, supplied by Gelsenwasser, waterworks, D-W-4358 Haltern
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30 - 70%
- Photoperiod: Artificial light, 12-hour light/dark rhythm

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal skin
- Type of wrap: mull patch

REMOVAL OF TEST SUBSTANCE
- Washing: no

TEST MATERIAL
- Amount applied: 2.2 cm3/kg bodyweigh

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: after 1/2, 1, 2, 3, 4, 5 and 6 hours and once a day for the next two weeks
- Frequency of weighting: day 0, 7 and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured.

Clinical signs:

other: No signs of toxicity related to the test substance were found during the 14-day observation period. The animals showed no dermal reactions 24 hours after administration and up to the end of the observation period.

Gross pathology:

The necropsies at the end of the study revealed no macroscopic changes to organs, nor were there any abnormalities in the skin and subcutaneous tissue in the application area.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal toxicity test according to OECD 402 with male and female rats determined a LD50 > 2000 mg/kg bw.

Executive summary:

The test of the acute dermal toxicity of the test item for male and female rats with undiluted test substance in a limit test with a dose of 2000 mg/kg bodyweight according to OECD 402 was conducted. The volume administered was 2.2 cm3/kg bodyweight. Five male and five female animals showed normal bodyweight change during the 14-day observation period. No signs of toxicity related to the substance occurred either in the males or in the females. Necropsy at the end of the test showed no evidence of macroscopic changes to organs of any of the animals. The median lethal dose (LD5O) found in the limit test for acute dermal toxicity in rats was 2000 mg/kg bw.