Registration Dossier

Diss Factsheets

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

Referenceopen allclose all

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

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

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

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.

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.