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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Justification for type of information:
Justification is provided in the separate statement.
Reason / purpose for cross-reference:
assessment report
Reason / purpose for cross-reference:
assessment report
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

Constituent 1
Chemical structure
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:
no clinical signs were found
Body weight:
the development of body weight within the observation period of 14 days were normal
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.