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

Endpoint summary

Description of key information

To assess the acute oral toxicity a valid acute oral toxicity study is available which were performed in accordance to OECD 401.

No study on acute inhalation toxicity is available. Inhalation of registered substance is unlikely due to the following reason: The vapour pressure of the registered substance is 0.00035 Pa. During manufacturing and processing inhalation exposure is unlikely due to efficient control measures in place. There is no spray application.

No study on acute dermal toxicity is available. Absorption via dermal exposure of the test substance is unlikely due to the following reason: The manufacture is performed in closed systems. Due to the size of the molecule (MW is about 700 g/mol) it is likely that the substance will not be readily absorbed through the skin. Even when absorbed through the skin, due to the demonstrated low systemic toxicity of the test item the dermal toxicity should be of no concern. Further, the test substance is not a skin irritant or sensitizer.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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)

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

Specific details on test material used for the study:

Physical state: white waxi paste

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

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

10 000 mg/kg bw

Quality of whole database:

The study is a GLP conform scientific study in rats according to OECD 401.

Additional information

In order to evaluate the acute oral toxicity potential of the test substance registered, a valid study for testing acute oral toxicity isavailable. The rats received a single dose of 10000 mg/kg body weight via gavage. No mortality occurred, the bodyweight over the observation period of 14 days was not impaired, no signs of toxicity were observed. After the observation period of 14 days all rats were sacrificed. The animals killed at the end of the observation period showed no macroscopically visible changes. The LD50 (oral) was determined greater than 10000 mg/kg body weight.

No study on acute inhalation toxicity is available. Inhalation of registered substance is unlikely due to the following reason: The vapour pressure of the registered substance is 0.00035 Pa (at 20°C). During manufacturing and processing inhalation exposure is unlikely due to efficient control measures in place. There is no spray application.

No study on acute dermal toxicity is available. Absorption via dermal exposure of the test substance is unlikely due to the following reason: The manufacture is performed in closed systems. Due to the size of the molecule (MW is about 700 g/mol) it is unlikely that the substance will be absorbed through the skin. Even when absorbed through the skin, due to the demonstrated low systemic toxicity of the test item it would be of no concern. Further, the test substance is not a skin irritant or sensitizer.

Justification for classification or non-classification

According to Regulation (EC) No 1272/2008 of the European Parliament and of the council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, the test substance Hostacerin DGSB has not to be classified.