L-Glutamic acid, N-coco acyl derivs., monosodium salts

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

Data is from study report. Test was performed according to Flex Wash Test

GLP compliance:

no

Species:

human

Details on test animals or test system and environmental conditions:

20 subjects, both males and females, aged between 18 and 65 years had to put known quantities of product on anticubital fold of the arm, massage gentle for 30 seconds and wash.

Type of coverage:

open

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

10% active matter

Duration of treatment / exposure:

30 seconds

Observation period:

The test was repeated three times a day for ten consecutive days.

Number of animals:

20 subjects, both males and females

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 30 seconds

Score:

0.5

Max. score:

1

Reversibility:

no data

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Skin irritation of Protelan AGL 95 was evaluated through a Flex Wash Test (10% active matter). 20 subjects, both males and females, aged between 18 and 65 years had to put known quantities of product on anticubital fold of the arm, massage gentle for 30 seconds and wash.

Executive summary:

Skin irritation of Protelan AGL 95 was evaluated through a Flex Wash Test (10% active matter). 20 subjects, both males and females, aged between 18 and 65 years had to put known quantities of product on anticubital fold of the arm, massage gentle for 30 seconds and wash. The test was repeated three times a day for ten consecutive days. The index of average irritation according to the amended Draize classification was 0.5. Also, it has been observed that below this (0.5) value, products are not irritating. Thus, it can be concluded that the test substance is mildly irritant to skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

(Q)SAR

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Justification for type of information:

QSAR prediction: migrated from IUCLID 5.6

Qualifier:

according to guideline

Guideline:

other: estimated data

Principles of method if other than guideline:

Data is predicted by QSAR toolbox version 3.1

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Age-12 weeks
Acclimation period: at least 5 days

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eyes of same animals

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

single application

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

3

Irritation parameter:

overall irritation score

Basis:

mean

Score:

17.4

Reversibility:

other: no effects noted

Remarks on result:

other: Not irritating

The prediction was based on dataset comprised from the following descriptors: MMAS
Estimation method: Takes average value from the 5 nearest neighbours
Domain  logical expression:Result: In Domain

(((("a" and ("b" and ( not "c") )  )  and "d" )  and "e" )  and ("f" and "g" )  )

Domain logical expression index: "a"

Similarity boundary:Target: C(=O)(O)C(CCC(=O)O{-}.[Na]{+})NCCCCCCCCCCCC
Threshold=50%,
Dice(Atom pairs)

Domain logical expression index: "b"

Referential boundary: The target chemical should be classified as Alkali Earth AND Non-Metals by Groups of elements

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as Halogens by Groups of elements

Domain logical expression index: "d"

Similarity boundary:Target: C(=O)(O)C(CCC(=O)O{-}.[Na]{+})NCCCCCCCCCCCC
Threshold=50%,
Dice(Atom pairs)

Domain logical expression index: "e"

Similarity boundary:Target: C(=O)(O)C(CCC(=O)O{-}.[Na]{+})NCCCCCCCCCCCC
Threshold=80%,
Dice(Atom pairs)

Domain logical expression index: "f"

Parametric boundary:The target chemical should have a value of logP Multicase which is >= 3.86

Domain logical expression index: "g"

Parametric boundary:The target chemical should have a value of logP Multicase which is <= 5.37

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The modified maximum average score (MMAS) from QSAR ,eye irritation score of l-Glutamic acid, N-coco acyl derivs., monosodium salts was estimated as 17.4.

Executive summary:

The modified maximum average score (MMAS) from QSAR ,eye irritation score of l-Glutamic acid, N-coco acyl derivs., monosodium salts was estimated as 17.4. This score indicates that l-Glutamic acid, N-coco acyl derivs., monosodium salts is not irritating to the eye of rabbit.(as the criteria MMAS <25 is not irritating) which is also supported by the study report for the same chemical. Thus based on the weight of evidences of the study and prediction it can be concluded that the target is non irritant to eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation :

It is well-known that the irritating properties of surfactants play a major role in the skin compatibility of surfactant-based formulations. As the irritation potential is dependent on the amount of the irritant interacting with the skin, a decrease in this interaction should increase the compatibility of the composition. The addition of a co-surfactant can reduce the amounts of the irritant. This has been shown by the study conducted by Sugar & Schmucker in which the addition of sodium cocoyl glutamate reduced the adsorption of SLES to the skin in a dose-dependent manner. Thus based on the weight of evidences mentioned in the end point suudies of skin irritation, it can be concluded that the target chemical is not a skin irritant but can be considered a suitable option for reducing the effect.

Eye Irritation :

The modified maximum average score (MMAS) from QSAR ,eye irritation score of l-Glutamic acid, N-coco acyl derivs., monosodium salts was estimated as 17.4. This score indicates that l-Glutamic acid, N-coco acyl derivs., monosodium salts is not irritating to the eye of rabbit.(as the criteria MMAS <25 is not irritating) which is also supported by the study report for the same chemical. Thus based on the weight of evidences of the study and prediction it can be concluded that the target is non irritant to eyes.

Justification for selection of skin irritation / corrosion endpoint:

Skin irritation of Protelan AGL 95 was evaluated through a Flex Wash Test (10% active matter). 20 subjects, both males and females, aged between 18 and 65 years had to put known quantities of product on anticubital fold of the arm, massage gentle for 30 seconds and wash. The test was repeated three times a day for ten consecutive days. The index of average irritation according to the amended Draize classification was 0.5. Also, it has been observed that below this (0.5) value, products are not irritating. Thus, it can be concluded that the test substance is mildly irritant to skin.

Justification for selection of eye irritation endpoint:

The modified maximum average score (MMAS) from QSAR ,eye irritation score of l-Glutamic acid, N-coco acyl derivs., monosodium salts was estimated as 17.4. This score indicates that l-Glutamic acid, N-coco acyl derivs., monosodium salts is not irritating to the eye of rabbit.(as the criteria MMAS <25 is not irritating) which is also supported by the study report for the same chemical. Thus based on the weight of evidences of the study and prediction it can be concluded that the target is non irritant to eyes.

Justification for classification or non-classification

Based on the weight of evidences for skin and eye irritation, it can be concluded that the target chemical is not an irritant and the substance can be considered a suitable option for reducing the irritation effect on skin.