Fatty acids, C16-18 (even numbered), esters with 1,2,3-propanetriol and oligomers, ethoxylated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980-02-12 to1980-02-26

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Test was performed as limit test in 10 females.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18 (even numbered), esters with 1,2,3-propanetriol and oligomers, ethoxylated

IUPAC Name:

Fatty acids, C16-18 (even numbered), esters with 1,2,3-propanetriol and oligomers, ethoxylated

Test material form:

solid

Specific details on test material used for the study:

Physical state: white waxi paste

Test animals

Species:

rat

Strain:

other: Wistar

Remarks:

Hoe WISKf(SPF71) breading at Hoechst company

Sex:

female

Details on test animals or test system and environmental conditions:

weight: 174 to 191 g
Mean weight: 180.5 +- 4.93g
- Housing:
- Diet (e.g. ad libitum): ALTEOMIN GmbH, Lage /Lippe, Germany)
- Water (e.g. ad libitum): Tap water

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Remarks:

at about 33°C

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25 % solution (i.e. 25g/ ad 100 mL) in sesame oil at 33 ° C.

Doses:

10 000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once weekly weighing
- Necropsy of survivors performed: yes, gross pathology examination

Statistics:

n.a.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

other: limit dose

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: none

Gross pathology:

n.a.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the available results of an acute oral toxiicty study in female Wistar rats a clear LD50 value could not be determined but the LD50 is assumed greater than 10000 mg/kg

Executive summary:

In order to evaluate the acute oral toxicity of Hostacerin DGSB an acute orl toxicity test was performed. The test item was applied to 10 female Wistar rats by oral gavage at a concentration of 10000 mg/kg bw in sesame oil as vehicle (25g of test item was disolved in 100 ml of sesame oile at 33 °C). Food was restricted 16 hours prior and 2 hour after application of test item. Tap water was allowed ad libitum. The animals were observed for any clinical sign of toxicity for a period of 14 days. Body weight was taken weekly during the 14 day observation period.

No clinical signs and no mortality was observed during the 14 day observation period. At the end of the observation period the rats were sacrficed by CO2 and necropsied. There were no gross pathological effect observed. The determination of an LD 50 was not possibel but it is assumed to be greater than 10000 mg/kg.