fatty acid chloride, C12, reaction product with sodium glutamate and sodium hydroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Reason / purpose for cross-reference:

assessment report

Reference

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

Justification is provided in the separate statement.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Key result

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity of the registration substance Sodium N-lauroyl glutamate is derived based on the read-across to Sodium N-cocoyl glutamate and Sodium N-cocoyl glycinate. The LD50 > 2000 mg/kg bw can be reliably derived.

Executive summary:

The acute oral toxicity of the registration substance, sodium N-lauroyl glutamate, is derived based on the read-across to sodium N-cocoyl glutamate and sodium N-cocoyl glycinate.

Sodium N-cocoyl glutamate was investigated for its acute oral toxicity according to the OECD 401. Five male and five female rats were treated per gavage at dose 2000 mg/kg bw. No effect was found. LD50 > 2000 mg/kg bw was obtained.

Sodium N-cocoyl glycinate was investigated for its acute oral toxicity according to the OECD 423. Six female rats were treated per gavage at dose 2000 mg/kg bw. No effect was found. LD50 > 2000 mg/kg bw was obtained.

Likewise the LD50 > 2000 mg/kg bw can be reliably derived for the registration substance, sodium N-lauroyl glutamate.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

L-Glutamic acid, N-coco acyl derivs., disodium salts

EC Number:

269-085-1

EC Name:

L-Glutamic acid, N-coco acyl derivs., disodium salts

Cas Number:

68187-30-4

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Disodium (2S)-2-aminopentanedioate

Test material form:

liquid: viscous

Details on test material:

Description: clear, very pale straw-coloured, viscous liquid
Container: plastic screw-top jar
Sponsor's identification: HOE S 3580-2
Batch number: E01-115886
Storage conditions: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Observation period of 14 days

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

no mortality was found

Clinical signs:

other: no clinical signs were found

Gross pathology:

no effect found

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Sodium N-cocoyl glutamate was investigated for its acute oral toxicity according to the OECD 401. The LD50 > 2000 mg/kg bw was obtained.

Executive summary:

Sodium N-cocoyl glutamate was investigated for its acute oral toxicity according to the OECD 401. Five male and five female rats were treated per gavage with 2000 mg/kg bw with the test item. No effect was found. The LD50 > 2000 mg/kg bw was obtained.