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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Remarks:
Internal company data
Type of information:
other: Internal company data
Remarks:
Internal company data
Adequacy of study:
supporting study
Study period:
2018
Reliability:
4 (not assignable)
Species:
other: Not specified
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
Not specified
Route of administration:
other: oral
Vehicle:
not specified
Details on oral exposure:
Not specified
Doses:
Not specified
No. of animals per sex per dose:
Not specified
Details on study design:
Not specified
Statistics:
Not specified
Preliminary study:
Not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Not specified
Clinical signs:
Not specified
Body weight:
Not specified
Gross pathology:
Not specified
Other findings:
Not specified
Interpretation of results:
GHS criteria not met
Conclusions:
Lethal dose oral is > 2000 mg/kg bw
Executive summary:

Lethal dose oral is > 2000 mg/kg bw

Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Data are being assessed for the use in a category approach. Available information are being judged as reliable with restrictions since it was conducted by a modeled and measured data.
Remarks:
Data are being assessed for the use in a category approach. Available information are being judged as reliable with restrictions since it was conducted by a modeled and measured data.
Justification for type of information:
Modeled and measured data

Important considerations for the read-across were:

Sodium Olivoyl Glutamate (the target chemical) has similar physico-chemical properties as the others members:
- "Aliphatic acid category" (the source chemicals);
- "Amino acid alkyl amides category" (the source chemicals);
- Sodium oleoyl glutamate (the source chemicals);

Key points are that the members share:
- the same structural features
- similar metabolic pathways
- common levels and mode of human health related effects
- function.


Important considerations for the read-across were:

sodium Olivoyl Glutamate (the target chemical) has similar physico-chemical properties as the others members of the followings Categories:
- "Aliphatic acid category" (the source chemicals);
- "Amino acid alkyl amides category" (the source chemicals);

Key points are that the members share:
- the same structural features
- similar metabolic pathways
- common levels and mode of human health related effects
Principles of method if other than guideline:
Data available is referred to aliphatic acids category.
GLP compliance:
not specified
Test type:
acute toxic class method
Specific details on test material used for the study:
not specified
Species:
other: Category data
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
not specified
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
not specified
Doses:
not specified
No. of animals per sex per dose:
not specified
Control animals:
not specified
Details on study design:
not specified
Statistics:
not specified
Preliminary study:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 values in rats for aliphatic acids category were greater than >2000 mg/kg bw (similar to OECD 401). Clinical signs were generally associated with poor condition following administration of high doses (salivation, diarrhea, staining, piloerection and lethargy). There were no adverse effects on body weight. In some studies, excess test substance and/or irritation in the gastrointestinal tract was observed at necropsy.
Executive summary:

The acute oral LD50 is greater than >2000 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Justification for type of information:
Important considerations for the read-across were:

Sodium Olivoyl Glutamate (the target chemical) has similar physico-chemical properties as the others members:
- "Aliphatic acid category" (the source chemicals);
- "Amino acid alkyl amides category" (the source chemicals);
- Sodium oleoyl glutamate (the source chemicals);

Key points are that the members share:
- the same structural features
- similar metabolic pathways
- common levels and mode of human health related effects
- function.
Key result
Remarks on result:
not measured/tested
Interpretation of results:
GHS criteria not met
Conclusions:
Overall, considering available data on (i) the substance and (ii) on the category members the substance have a lethal dose oral > 2000 mg/kg bw.
Executive summary:

Lethal dose oral > 2000 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Modeled and measured data

Important considerations for the read-across were:

Sodium Olivoyl Glutamate (the target chemical) has similar physico-chemical properties as the others members:
- "Aliphatic acid category" (the source chemicals);
- "Amino acid alkyl amides category" (the source chemicals);
- Sodium oleoyl glutamate (the source chemicals);

Key points are that the members share:
- the same structural features
- similar metabolic pathways
- common levels and mode of human health related effects
- function.
Qualifier:
according to guideline
Guideline:
other: Not specified
GLP compliance:
yes
Test type:
acute toxic class method
Specific details on test material used for the study:
not specified
Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
not specified
Doses:
not specified
No. of animals per sex per dose:
not specified
Control animals:
not specified
Details on study design:
not specified
Statistics:
not specified
Preliminary study:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 8 300 mg/kg bw
Mortality:
not specified
Clinical signs:
not specified
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified

not specified

Interpretation of results:
GHS criteria not met
Conclusions:
For the substance, mouse oral LD50 is 8300 mg/kg.
Executive summary:

Mouse oral LD50 is 8300 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Overall, considering available data on (i) the substance and (ii) on the category members the substance have a lethal dose oral > 2000 mg/kg bw.

Justification for classification or non-classification

According to Regulation (EC) n. 1272/2008, the study results indicate that the substance should not be classified for acute oral toxicity because data are judged as "conclusive but not sufficient for classification".

According to Regulation (EC) n. 1272/2008, the substance should not be classified for acute inhalation toxicity because of data lacking.

According to Regulation (EC) n. 1272/2008, the substance should not be classified for acute dermal toxicity because of data lacking.