C18 (branched) fatty acids, esters with mono-, di-, and tri-glycerol

Endpoint summary

Description of key information

To assess the acute oral toxicity two valid studies are 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 0.000418 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, neither in rats nor in human (patch tests).

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:

1980-07-31 to 1980-08-14

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study result presented as summary but includes all relevant information. Study was performed prior to implementation of GLP but carried out according to the principles of GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

Study was performed prior to implementation of GLP

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Route of administration:

oral: gavage

Vehicle:

water

Doses:

5000 mg/kg body weight

No. of animals per sex per dose:

10 females

Control animals:

no

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortallity occurred during the subsequent observation of 14 days.

Clinical signs:

other: Minor clinical symptoms, i.e. squatting posture, hair-raising, have been observed, but were reversible within 24 hours post application of test item.

Gross pathology:

The animals killed at the end of the observation period showed no macroscopcally visible changes.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the study results, the acute oral toxicity (LD50) of the test substance registered is greater than 5000 mg/kg body weight.

Executive summary:

Based on the study results, the acute oral toxicity (LD50) of Hoe S 2721 in the rat is greater than 5000 mg/kg body weight. Accordingly Hoe S 2721 is not subject for labelling requirements with regard to acute oral toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Reliability of 2.

Additional information

In order to evaluate the acute oral toxicity potential of the test substance registered, two valid studies for testing acute oral toxicity are available. In both studies the rats received a single dose of 5000 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 5000 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 0.000418 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, neither in rats nor in human (patch tests).

Justification for selection of acute toxicity – oral endpoint
To assess the acute oral toxicity a valid study is available which was performed in accordance to OECD 401.

Justification for classification or non-classification

Based on the available data no classification is warranted according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).