Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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:
- other: 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:
- other: not specified
- Gross pathology:
- not specified
- Other findings:
- 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.
Referenceopen allclose all
not specified
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
