Reaction mass of sodium hydrogen N-(1-oxooctadecyl)-L-glutamate and stearic acid

Endpoint summary

Description of key information

The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat, was found to be greater than 2000 mg/kg bodyweight.
The acute dermal median lethal dose (LD50) was determined to be >5000 mg/kg bw LD50 in rats.

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:

1989/10/25 - 1989/11/08

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The registered substance is a UVCB material which contains substances of varying chain length. Read across was performed to an analogous material whose carbon chain length differs by an average of two CH2-groups from the registered substance. Because of the UVCB nature of these substances, the components of the registered substance were also present in the test material, albeit at slightly different concentration levels.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bantin & Kingman Ltd., Grimston, Aldborough, Hull, U.K.
- Age at study initiation: 5-8 weeks
- Weight at study initiation: male: 120-145g; female: 120-137g
- Fasting period before study: overnight immediately before dosing and for approximately two hours after dosing
- Housing: in groups of 5 by sex in polypropylene cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 51-66
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.94 mL/kg bw

Doses:

single dose of 2000 mg/kg bw

No. of animals per sex per dose:

10 (5 males and 5 females)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once a day; bw were recorded on day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights, histopathology

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality occured.

Clinical signs:

other: No evidence of systemic toxicity was noted during the study period.

Gross pathology:

No abnormalities were noted at necropsy of animals killed at the end of the study.

Conclusion

The acute oral median lethal dose (LD50) of the test material, HOE S 3580-2, in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bw.

Executive summary

A study was performed to determine the acute oral median lethal dose (LD50) of the test material, administered undiluted, in the Sprague-Dawley strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 401 "Acute Oral Toxicity" referenced as Method B.1 in Annex V of EEC Commission Directive 84/449/EEC. A group of ten fasted Sprague-Dawley Rats (five males and five females) was given a single oral dose of undiluted test material at a dose level of 2000 mg/kg bodyweight. There were no deaths. No evidence of systemic toxicity was noted during the study period. No toxicologically significant effects on bodyweight were noted during the study period. No abnormalities were noted at necropsy of animals killed at the end of the study. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat, was found to be greater than 2000 mg/kg body-weight.

Interpretation of results:

not classified

Conclusions:

The test substance has not to be labelled with regard to oral toxicity.

Executive summary:

The test substance has been investigated for its oral toxicity in accordance with OECD guideline 401 under GLP conditions in male and female rats. All animals survived the treatment at the limit dose of 2000 mg/kg bw with no signs of toxicosis. The test substance has not to be labelled with regard to oral toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Quality of whole database:

Klimisch 2 study. The registered substance is a UVCB material which contains substances of varying chain length. Read across was performed to an analogous material whose carbon chain length differs by an average of two CH2-groups from the registered substance. Because of the UVCB nature of these substances, the components of the registered substance were also present in the test material, albeit at slightly different concentration levels.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The registered substance is a UVCB material which contains substances of varying chain length. Read across was performed to an analogous material whose carbon chain length differs by an average of two CH2-groups from the registered substance. Because of the UVCB nature of these substances, the components of the registered substance were also present in the test material, albeit at slightly different concentration levels. :

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Crl:WI (Han) SPF

Sex:

male/female

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 h

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

according to guideline

Statistics:

according to guideline

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: none

Gross pathology:

no abnormalities

Other findings:

slight edema (grade 1)

Interpretation of results:

practically nontoxic

Conclusions:

The acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 5000 mg/kg bw

Executive summary:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats(5 males and 5 females)were dermally exposed to a single dose of 5000 mg/kg bw of the undiluted test item L-Glutamic acid, N-coco acylderivs., disodiumsalts to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days.

 

• No mortality occurred
• No signs of systemic toxicity were observed
• The following test item-related local effects were recorded during the course of the study:

o  Very slight erythema (grade 1)

 

 

• The mean body weight of the male animals increased within the normal range throughout the study period.
• The mean body weight of the female animals did not adequately increase during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range.
• No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

 

Accordingly, the acute dermal median lethal dose (LD₅₀) was determined to be LD₅₀, dermal, rat > 5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Klimisch 2 study

Additional information

Oral:

To determine the acute oral median lethal dose (LD50), a study was performed with L-Glutamic acid, N-coco acyl derivs., monosodium salts (CAS 68187-32-6). A group of ten fasted animals (five males and five females) was given a single oral dose of undiluted test material at a dose level of 2000 mg/kg bodyweight. There were no deaths. No evidence of systemic toxicity was noted during the study period. No toxicologically significant effects on bodyweight were noted during the study period. No abnormalities were noted at necropsy of animals killed at the end of the study. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley rat was found to be greater than 2000 mg/kg body-weight.

 

Dermal:

In an acute dermal toxicity study (limit test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 5000 mg/kg bw of the undiluted test item L-Glutamic acid, N-coco acyl derivs., disodium salts(CAS 68187-30-4)to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days. No mortality, clinical signs or macroscopic changes occurred. Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 5000 mg/kg bw.

 

The read across justification is given in an extra rationale document.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No mortality occurred at the limit doses. As a result, the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.