Rape oil, reaction products with diethanolamine

Endpoint summary

Description of key information

The available data suggests that HE Rape Oil, reaction product with diethanolamine has a low potential for acute oral toxicity (i.e., LD50 >10,000 mg/kg bw) based on a study conducted with the read across substance C18-unsatd. DEA and dermal toxicity (i.e., LD50 >2,000 mg/kg bw) based on read across study conducted with C8-18 and C18-unsatd. DEA.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted on the structural analogue amides, C18(unsatd.), N,N-bis(hydroxyethyl) according to standard scientific principles.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline followed

Principles of method if other than guideline:

In the acute oral toxicity study, groups of adult SD rats were given the single calculated dose by stomach intubation and placed in screen bottom cages for a two week observation period and determination of lethal dose.

GLP compliance:

not specified

Test type:

other: No data provided

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: male: 150-250 g
- Fasting period before study: 24 h
- Housing: Screen bottom cages
- Diet (e.g. ad libitum): Laboratory chow (ad libitum)
- Water (e.g. ad libitum): ad libitum

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

Six adult SD rats per dose group were given the test substance by stomach intubation.

Doses:

5,000, 10,000 and 20,000 mg/kg.

No. of animals per sex per dose:

Males: 6/dose/group

Control animals:

not specified

Details on study design:

Male SD rats were fasted for 24 h and then administered single doses of the test substance by stomach intubation followed by 14 d of observation period.

Statistics:

No data

Sex:

male

Dose descriptor:

LD50

Effect level:

10 000 mg/kg bw

Based on:

test mat.

Mortality:

Number of dead/number dosed:
- No mortality occured at lowest dose of 5,000 mg/kg, i.e., 0/6
- 50% mortality was observed In the mid dose group of 10,000 mg/kg, i.e., 3/6
- Almost all animals died in the highest dose group of 20,000 mg/kg, i.e., 5/6.

None

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 of the test substance in SD rats was found to be 10,000 mg/kg bw. Hence, it can be considered to be not classified as per EU CLP classification system.

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance amides, C18 -unsatd., N,N-bis(hydroxyethyl) in SD rats. Under the study conditions, the oral LD50 was determined to be 10,000 mg/kg bw and does not meet the requirement for classification according to according to EC criteria (67/548/EEC) and according to CLP criteria (EC 1272/2008).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

10 000 mg/kg bw

Quality of whole database:

The information requirement for this tonnage band is sufficiently met with the available data.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Read across study conducted on the structural analogue amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl) hence maximum reliability rating of 2 assigned according to ECHA guidance, although study is acceptable, well-documented and meets basic scientific principles.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

other: A modification of the techniques described in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, compiled by the staff of the Division of Pharmacology, Food and Drug Administration.

Deviations:

not specified

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Test type:

other: LD50 limit test

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.9 to 2.7 kg

No further information available.

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Type of wrap if used: The trunk of each animal was encased in a sleeve of plasticized material after application of test material

Duration of exposure:

24 h

Doses:

2,000 mg/kg bw

No. of animals per sex per dose:

Three animals with abraded skin and three animals with intact skin

Control animals:

yes, concurrent no treatment

Details on study design:

- Duration of observation period following administration: Animals were observed immediately after dosing, and at 1, 6 and 24 h post-dosing. Following the 24 h exposure period, animals were observed for mortality, skin response and general behavior for 14 d

Statistics:

Not reported

Preliminary study:

Not applicable

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortalities observed

Clinical signs:

other: All animals appeared normal throughout the 24 h exposure period and the 14 d post-exposure observation period.

Gross pathology:

Not applicable

Other findings:

None

None

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the acute dermal LD50 of structurally similar amides, C8-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) was found to be > 2,000 mg/kg bw in albino rabbits.

Executive summary:

A study was conducted to determine the acute dermal toxicity of structurally similar amides, C8-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) in male/female albino rabbit.

The procedure was the modification of the techniques described in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, compiled by the staff of the Division of Pharmacology, Food and Drug Administration.

 

2 g/kg bw of test substance was applied (single application) to the abraded and intact skin of the test animals. The trunk of each animal was then encased in a sleeve of plasticized material to ensure contact of the test material for a 24 h period. Animals were observed immediately after dosing, and at 1, 6 and 24 h post-dosing. Following the 24 h exposure period, animals were observed for mortality, skin response and general behavior for 14 d.

 

No mortality was observed in this study. All animals appeared normal throughout the 24 h exposure period and the 14 d post-exposure observation period.

 

Under the test conditions, the acute dermal LD50 was found to be >2,000 mg/kg bw in albino rabbits and does not meet the requirement for classification according to according to EC criteria (67/548/EEC) and according to CLP criteria (EC 1272/2008).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The information requirement for this tonnage band is sufficiently met with the available data.

Additional information

Oral

The key study was conducted to determine the acute oral toxicity of the read across substance amides, C18(unsatd.), N,N-bis(hydroxyethyl) in SD rats. Under the test conditions, the oral LD50 was determined to be 10,000 mg/kg bw. Therefore, the test substance is considered to be of low acute oral toxicity (Casey LM, 1976).

 

A supporting study was performed to assess the acute oral toxicity of the read across substance amides, C18(unsatd.), N,N-bis(hydroxyethyl) in SD rat. Groups of 20 fasted animals (10 males and 10 females) were administered the test substance via oral gavage at 0, 10.0, 12.6, 16.0 and 20.0 mL/kg bw. The animals were observed for 14 d and were then sacrificed and subjected to gross pathological examination. Mortality occurred as of 12.6 mL/kg bw. Signs of toxicity included rough fur, pale extremities, diarrhea, increased lacrimation and slight to middle-strong lethargy and ataxia. Animals dying during the study showed slight to medium effects in the lung, liver, glands, stomach and duodenum. In animals sacrificed at the end of the study, light to medium effects were observed in the lungs, liver and stomach. Under the study conditions, the LD50 of the test substance in rat was found to be equivalent to 14.21 mL/kg bw (according to Kärber) or 13.82 mL/kg bw (according to Weil) (Sandhowe-Grote D, 1979). These LD50 values are equivalent to 14,210 and 13,820 mg/kg bw; assuming the density to be approx. 1 g/cm3. Based on read-across HE Rape Oil, reaction product with diethanolamine is expected to have low acute oral toxicity.

 

Dermal

A single application of 2,000 mg/kg bw of structurally similar amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl) applied to the abraded and intact skin of the test animals resulted in no mortality and all animals appeared normal throughout the 24 hour exposure period and during the 14 day post-exposure observation period. The dermal LD50 was determined to be >2,000 mg/kg bw which indicates a low acute dermal toxicity (Palanker AL, 1976) and therefore, based on read-across HE Rape Oil, reaction product with diethanolamine is also expected to have low acute dermal toxicity.

 

Inhalation

This endpoint is considered to be adequately addressed from the data available on acute oral and dermal toxicity in accordance with the REACH regulation and to avoid unnecessary animal testing. Furthermore, since the test substance has a very low vapour pressure, the normal processing and use conditions will not generate inhalation exposure. In case aerosols or vapours are created under particular conditions (e.g. spraying, elevated temperature/pressure), appropriate risk management measures such as closed systems, exhaust ventilation or wearing of respirators are implemented to control exposure. Under such conditions, the risk to humans following inhalation exposure can be considered minimal and further testing involving vertebrate animals may be omitted, in accordance with Annex XI (1.2) of the REACH regulation.

Justification for selection of acute toxicity – oral endpoint
The key study was well conducted according to standard scientific principles on the structural analogue amides, C18(unsatd.), N,N-bis(hydroxyethyl).

Justification for selection of acute toxicity – inhalation endpoint
This endpoint is considered to be adequately addressed from the data available on acute oral and dermal toxicity in accordance with the REACH regulation and to avoid unnecessary animal testing. Furthermore, since the test substance has a very low vapour pressure, the normal processing and use conditions will not generate inhalation exposure. In case aerosols or vapours are created under particular conditions (e.g. spraying, elevated temperature/pressure), appropriate risk management measures such as closed systems, exhaust ventilation or wearing of respirators are implemented to control exposure. Under such conditions, the risk to humans following inhalation exposure can be considered minimal and further testing involving vertebrate animals may be omitted, in accordance with Annex XI (1.2) of the REACH regulation.

Justification for selection of acute toxicity – dermal endpoint
The key study was well conducted according to standard scientific principles on the structural analogue amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl).

Justification for classification or non-classification

The available data indicates a low potential for acute toxicity (oral and dermal LD₅₀of 10,000 and >2,000 mg/kg bw respectively) of the structural analogue amides, C18 -unsatd., N,N-bis(hydroxyethyl) and does not meet the requirement for classification according to according to EC criteria (67/548/EEC) and according to CLP criteria (EC 1272/2008).