Reaction mass of 2-hydroxyethyl oleate, oleic acid, and 2-hydroxyethyl palmitate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 December 1991 - 27 December 1991

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:

other: OECD TG 401 (Acute Dermal Toxicity)

Version / remarks:

February 1987

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

EC Number:

927-763-0

Cas Number:

853947-59-8

Specific details on test material used for the study:

Batch number: 12430
General characteristics: Odourless oily liquid
Purity: Butanediol dioctanoate: 36.3 (% by area); Butanediol octanoate decanoate: 46.3 (% by area); Butanediol didecanoate: 15.1 (% by area)
Storage conditions: In a closed container in a laboratory hood
Stable until: 06/1993

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Body weight of animals at start of test: 200-300 g
Room temperature: 20±3°C
Rel humidity: 30-70%
Acclimitisation: At least 5 days

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The volume administered was 2.2 cm3/kg bw

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals/sex

Control animals:

not specified

Details on study design:

The animals were examined for clinical signs 1/2, 1, 2, 3, 4, 5 and 6 hours after administration and once a day for the next two weeks. The relevant area was examined for dermal reactions related to the test substance. The time of occurrence and the nature of the signs were recorded separately for each animal. The animals were weighed on the day of administration (day 0), on day 7 and at the end of the test (day 14). After the observation period of 14 days, all the animals were sacrificed by inhalation of carbon dioxide, necropsied and inspected for macroscopic changes to organs. The necropsy results were recorded separately for each animal.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no mortalities during the study.

Clinical signs:

other: No signs of toxicity related to the substance were found with the dose of 2000 mg/kg bodyweight during the 14-day 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.

Other findings:

The animals showed no dermal reactions 24 hours after administration and up to the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 is greater than 2000 mg/kg bw.

Executive summary:

In an acute toxicity study the substance was administered to Wistar rats (5 animals/sex/dose) by semi occlusive dermal application at a dose level of 2000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was as expected and no abnormalities found at macroscopic post-mortem examination. The dermal LD50 is greater than 2000 mg/kg bw.