Reaction products of N-lauroyl-L-glutamic acid with octyldodecanol and behenyl alcohol and beta-sitosterol and campesterol and stigmasterol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): Eldew PS-203
- Physical state: pale yellow, oily liquid
- Analytical purity: 100%
- Purity test date: not reported
- Lot/batch No.: 808010
- Expiration date of the lot/batch: 31.03.2000
- Storage condition of test material: test material was stored at room temperature (ca. 20°C), away from direct sunlight

Specific details on test material used for the study:

Identification: ELDEW PS-203
Description: pale yellow liquid
Batch: 808010
Expiry date: 31.03.2000
Purity: 100 %

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

33 - 5000 µg/plate

Vehicle / solvent:

acetone

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

methylmethanesulfonate

other: 4-NOPD, 2-AA

Details on test system and experimental conditions:

Two experiments were performed: plate incorporation test (experiment I) and pre-incubation test (experiment II)

Evaluation criteria:

According to guideline

Results and discussion

Test results

Test results 1

Key result

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

Plate incorporation assay: no cytotoxicity in all tested strains. Pre-incubation assay: -S9 mix: TA 1535 (>= 1000 µg/plate), TA 1537 (>= 33 µg/plate), TA 98 (5000 µg/plate), TA 100 (1000 µg/plate); +S9 mix: TA 1537 (1000 µg/plate)

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The test item was considered to be non-mutagenic in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvr A in study performed according to Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria).

Executive summary:

The test item was considered to be non-mutagenic in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvr A in study performed according to Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria).