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Toxicological information

Genetic toxicity: in vitro

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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 guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
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

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 / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
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
Controlsopen allclose all
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
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.