Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: - | CAS number: -
Toxicological information
Endpoint summary
Administrative data
Description of key information
Overall, considering available data on (i) the substance and (ii) on the category members:
- the substance is not skin irritant
- the substance is an eye irritant
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vitro and in vivo studies
- 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. - Irritation / corrosion parameter:
- other: in vitro and in vivo studies
- Remarks:
- in vitro and in vivo studies
- Remarks on result:
- not measured/tested
- Irritation parameter:
- other: in vitro and in vivo studies
- Remarks:
- in vitro and in vivo studies
- Remarks on result:
- not measured/tested
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Overall, considering available data on (i) the substance and (ii) on the category members the substance is not considered skin irritant.
- Executive summary:
According to Regulation (EC) n. 1272/2008, the study results indicate that the substance should not be classified for skin irritation because data are judged as "conclusive but not sufficient for classification".
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vitro and in vivo studies
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- 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:
- 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:
- no guideline available
- Principles of method if other than guideline:
- Data available is referred to aliphatic acids category.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- not specified
- Test system:
- other: not specified
- Source species:
- other: not specified
- Cell type:
- other: not specified
- Cell source:
- other: not specified
- Source strain:
- not specified
- Details on animal used as source of test system:
- not specified
- Justification for test system used:
- not specified
- Vehicle:
- not specified
- Details on test system:
- not specified
- Amount/concentration applied:
- not specified
- Duration of treatment / exposure:
- not specified
- Duration of post-treatment incubation (if applicable):
- not specified
- Number of replicates:
- not specified
- Species:
- other: not specified
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- not specified
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Amount / concentration applied:
- not specified
- Duration of treatment / exposure:
- not specified
- Observation period:
- not specified
- Number of animals:
- not specified
- Details on study design:
- not specified
- Irritation / corrosion parameter:
- other: See conclusion
- Run / experiment:
- See conclusion
- Vehicle controls validity:
- other: not specified
- Negative controls validity:
- other: not specified
- Positive controls validity:
- other: not specified
- Remarks on result:
- other: See conclusion
- Remarks:
- See conclusion
- Other effects / acceptance of results:
- See conclusion
- Irritation parameter:
- other: See conclusion
- Remarks:
- See conclusion
- Basis:
- other: See conclusion
- Remarks:
- See conclusion
- Time point:
- other: See conclusion
- Reversibility:
- not specified
- Remarks:
- See conclusion
- Remarks on result:
- other: See conclusion
- Remarks:
- See conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Skin and eye irritation potential is chain length dependent and decreases with increasing chain length. The animal skin irritation studies (generally similar to OECD 404) indicate that the C6-10 aliphatic acids are severely irritating or corrosive, while the C12 aliphatic acid has lower irritation potential, and the C14-22 aliphatic acids generally are not irritating or are slightly or mildly irritating. Studies in human volunteers, using up to ten sequential 24-hour occluded exposure periods, demonstrate that the C8-12 aliphatic acids are the most irritating, with the C14-18 aliphatic acids having lower irritation potential. Human skin irritation studies using more realistic exposures (30-minute, 1-hour or 24- hours) indicate that the aliphatic acids have sufficient, good or very good skin compatibility.
- Executive summary:
C14-18 aliphatic acids having lower irritation potential. Human skin irritation studies using more realistic exposures (30-minute, 1-hour or 24- hours) indicate that the aliphatic acids have sufficient, good or very good skin compatibility.
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vitro and in vivo studies
- 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:
- secondary literature
- 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. - Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Data available is referred to Amino Acid Alkyl Amides.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- not specified
- Test system:
- other: not specified
- Source species:
- other: not specified
- Cell type:
- other: not specified
- Cell source:
- other: not specified
- Source strain:
- not specified
- Details on animal used as source of test system:
- not specified
- Justification for test system used:
- not specified
- Vehicle:
- not specified
- Details on test system:
- not specified
- Amount/concentration applied:
- not specified
- Duration of treatment / exposure:
- not specified
- Duration of post-treatment incubation (if applicable):
- not specified
- Number of replicates:
- not specified
- Species:
- other: not specified
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- not specified
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Amount / concentration applied:
- not specified
- Duration of treatment / exposure:
- not specified
- Observation period:
- not specified
- Number of animals:
- not specified
- Details on study design:
- not specified
- Irritation / corrosion parameter:
- other: See conclusion
- Run / experiment:
- See conclusion
- Vehicle controls validity:
- other: not specified
- Negative controls validity:
- other: not specified
- Positive controls validity:
- other: not specified
- Remarks on result:
- other: See conclusion
- Other effects / acceptance of results:
- See conclusion
- Irritation parameter:
- other: See conclusion
- Remarks:
- See conclusion
- Basis:
- other: See conclusion
- Remarks:
- See conclusion
- Time point:
- other: See conclusion
- Reversibility:
- not specified
- Remarks:
- See conclusion
- Remarks on result:
- other:
- Remarks:
- See conclusion
- Irritant / corrosive response data:
- See conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No irritation was observed in in vitro studies with disodium capryloyl glutamate when tested at concentrations of 1.85% to 2.05%. A cream containing 8% acetyl proline was a mild irritant in another in vitro study. In rabbits, lauroyl lysine was nonirritating when tested at a concentration of 20%, whereas sodium lauroyl glutamate was a mild irritant at a concentration of 5%. In human studies, acetyl proline (up to 10%), acetyl tyrosine (up to 2%), disodium capryloyl glutamate (up to 7.38%), sodium cocoyl glutamate (up to 10%), sodium lauroyl glutamate (up to 10%), and sodium lauroyl silk amino acids (up to 6%) were not dermal irritants
- Executive summary:
In human studies, acetyl proline (up to 10%), acetyl tyrosine (up to 2%), disodium capryloyl glutamate (up to 7.38%), sodium cocoyl glutamate (up to 10%), sodium lauroyl glutamate (up to 10%), and sodium lauroyl silk amino acids (up to 6%) were not dermal irritants.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- in vitro and in vivo study
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- 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. - Qualifier:
- according to guideline
- Guideline:
- other: Not specified
- Principles of method if other than guideline:
- Data available is referred to Amino Acid Alkyl Amides.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- not specified
- Species:
- other: not specified
- Strain:
- not specified
- Remarks:
- not specified
- Details on test animals or tissues and environmental conditions:
- not specified
- Vehicle:
- not specified
- Amount / concentration applied:
- not specified
- Duration of treatment / exposure:
- not specified
- Observation period (in vivo):
- not specified
- Duration of post- treatment incubation (in vitro):
- not specified
- Number of animals or in vitro replicates:
- not specified
- Details on study design:
- not specified
- Irritation parameter:
- other: See conclusion
- Run / experiment:
- See conclusion
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: See conclusion
- Other effects / acceptance of results:
- See conclusion
- Irritation parameter:
- other: See conclusion
- Basis:
- other: See conclusion
- Time point:
- other: See conclusion
- Reversibility:
- other: See conclusion
- Remarks on result:
- other: See conclusion
- Irritant / corrosive response data:
- See conclusion
- Other effects:
- See conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Animal eye irritation studies (generally similar to OECD 405) indicate that among the sponsored aliphatic acids, the C8-12 aliphatic acids are irritating to the eye while the C14-22 aliphatic acids are not irritating. Conflicting skin and eye irritation data were located for one magnesium salt (not irritating to skin or eye) and one ammonium salt (not irritating to skin; corrosive to eye); these salts are not expected to be irritating to the skin and eyes.
- Executive summary:
- C8-12 aliphatic acids are irritating to the eye
- C14-22 aliphatic acids are not irritating
- Endpoint:
- eye irritation, other
- Remarks:
- in vitro and in vivo studies
- 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:
- secondary literature
- 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. - Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Data available is referred to aliphatic acids category.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- not specified
- Species:
- other: not specified
- Strain:
- not specified
- Remarks:
- not specified
- Details on test animals or tissues and environmental conditions:
- not specified
- Vehicle:
- not specified
- Amount / concentration applied:
- not specified
- Duration of treatment / exposure:
- not specified
- Observation period (in vivo):
- not specified
- Duration of post- treatment incubation (in vitro):
- not specified
- Number of animals or in vitro replicates:
- not specified
- Details on study design:
- not specified
- Irritation parameter:
- other: See conclusion
- Run / experiment:
- See conclusion
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: See conclusion
- Other effects / acceptance of results:
- See conclusion
- Irritation parameter:
- other: See conclusion
- Basis:
- other: See conclusion
- Time point:
- other: See conclusion
- Reversibility:
- other: See conclusion
- Remarks on result:
- other: See conclusion
- Irritant / corrosive response data:
- See conclusion
- Other effects:
- See conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No ocular irritation was observed in in vitro studies of acetyl tyrosine (up to 1.25%), disodium capryloyl glutamate (up to 2%), and sodium lauroyl glutamate (up to 5%). Severe irritation was observed with sodium cocoyl glutamate at 5% using the hen’s egg test chorioallantoic membrane (HET-CAM) method, but it was not irritating in another study with an unknown concentration. Slight irritation was observed with sodium lauroyl silk amino acids at 0.5% using the HETCAM method. Lauroyl arginine in a mixture at 10% was not irritating to rabbit eyes. No adverse effects were observed during in-use studies of eye-area products containing acetyl hydroxyproline (up to 2%) and acetyl tyrosine (up to 2%) in human participants.
- Executive summary:
Slight irritation was observed with sodium lauroyl silk amino acids at 0.5% using the HETCAM method.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Qualifier:
- according to guideline
- Guideline:
- other: Red Blood Cell test
- GLP compliance:
- yes
- Species:
- other: Red Blood Cell
- Strain:
- other: Red Blood Cell
- Details on test animals or tissues and environmental conditions:
- Not relevant
- Vehicle:
- not specified
- Amount / concentration applied:
- not specified
- Duration of treatment / exposure:
- not specified
- Observation period (in vivo):
- not specified
- Duration of post- treatment incubation (in vitro):
- not specified
- Number of animals or in vitro replicates:
- not specified
- Details on study design:
- not specified
- Irritation parameter:
- other: Red Blood Cell test
- Run / experiment:
- Not specified
- Vehicle controls validity:
- other: Not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: non irritating
- Other effects / acceptance of results:
- not specified
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In-vitro safety evaluations (Red Blood Cell test), Sodium Olivoyl Glutamate is judged as non irritating.
- Executive summary:
Sodium Olivoyl Glutamate is non irritating.
- Endpoint:
- eye irritation, other
- 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)
- Rationale for reliability incl. deficiencies:
- other: Internal Company data
- Remarks:
- Internal Company data
- Qualifier:
- no guideline available
- GLP compliance:
- yes
- Species:
- other: Not specified
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Not specified
- Vehicle:
- not specified
- Amount / concentration applied:
- Not specified
- Duration of treatment / exposure:
- Not specified
- Observation period (in vivo):
- Not specified
- Duration of post- treatment incubation (in vitro):
- Not specified
- Number of animals or in vitro replicates:
- Not specified
- Details on study design:
- Not specified
- Irritation parameter:
- other: Irritation
- Remarks:
- Irritation
- Remarks on result:
- other: the subtance is considered Irritant
- Remarks:
- Eye irritant
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The subtance is classified as Eye Irrit. 2; H319.
- Executive summary:
The subtance is classifed as eye irritant.
- Endpoint:
- eye irritation, other
- Remarks:
- Read-across based on grouping of substances (category approach)
- 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. - Irritation parameter:
- other: Read-across based on grouping of substances (category approach)
- Remarks:
- Read-across based on grouping of substances (category approach)
- Remarks on result:
- not measured/tested
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Overall, considering available data on (i) the substance and (ii) on the category members the substance is considered an eye irritant.
- Executive summary:
According to Regulation (EC) n. 1272/2008, the study results indicate that the substance should be classified as Eye Irrit. 2; H319.
Referenceopen allclose all
See conclusion
See conclusion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
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 is considered an eye irritant.
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 skin irritation because data are judged as "conclusive but not sufficient for classification".
According to Regulation (EC) n. 1272/2008, the study results indicate that the substance should be classified as Eye Irrit. 2; H319.
According to Regulation (EC) n. 1272/2008, study results indicate that the substance should not be classified for specific target organ toxicity - single exposure (H335) 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.
