12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Ames-Test (Mutation Research 31, 347 - 364 (1975))

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Amides, coco, N-(hydroxyethyl)

EC Number:

268-770-2

EC Name:

Amides, coco, N-(hydroxyethyl)

Cas Number:

68140-00-1

IUPAC Name:

Amides, coco, N-(hydroxyethyl)

Test material form:

solid

Details on test material:

- Name as cited in the report: Comperlan 100
- Chemical name: Amides, coco, N-(hydroxyethyl)
No further details stated in the report.

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:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

postmitochondrial supernatant fluids from the liver of male rats treated with Aroclor 1254 (S-9 mix)

Test concentrations with justification for top dose:

4, 20, 100, 500 and 2500 µg/plate

Vehicle / solvent:

Water / Tween 80

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

not specified

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

other: 4-Nitro-o-phenylendiamine

Remarks:

without S9 mix

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

not specified

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

with S9 mix

Details on test system and experimental conditions:

Aqueous suspensions of the test compound ware freshly made up with Tween 80 before use.

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537, TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The test item did not show any mutagenic activity in this bacterial reverse mutation assay.

Executive summary:

Comperlan 100 was tested for mutagenic activity in the bacterial tester strains Salmonella typhimurium TA 100, TA 1535, TA 1537, TA 1538, and TA 98.

The test was conducted on agar plates in the absence or presence of postmitochondrial supernatant fluids from the liver of male rats treated with Aroclor 1254 (S-9 mix). Aqueous suspensions of the test compound ware freshly made up with Tween 80 before use.

The following concentrations were tested: 4, 20, 100, 500 and 2500 µg Comperlan 100 per plate.

Comperlan 100 did not induce reverse mutations in the absence or presence of S-9 mix in the tester strains TA 100, TA 1535, TA 1537, TA 1538, and TA 98.

Comperlan 100 did not show mutagenic activity in vitro.