Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-11-09 to 1999-12-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study; well-performed and well documented.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
sodium/triethanolamine 4-((2-hydroxyethyl)amino)-3-pentaproenyl-4-oxobutanoate
EC Number:
800-765-8
Cas Number:
1424149-03-0
Molecular formula:
C21H40NO4.1/2Na.1/2C6H15NO3
IUPAC Name:
sodium/triethanolamine 4-((2-hydroxyethyl)amino)-3-pentaproenyl-4-oxobutanoate

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
Deionized water
Details on exposure:
The test substance was administered twice at an interval of 24 hours orally by gavage to the test animals at a dose of 2000 mg per kg body weight. The vehicle, deionized water, was administered in the same way to the negative control groups.
Duration of treatment / exposure:
2 days
Frequency of treatment:
once per day
Post exposure period:
24 hours after second application the animals were killed.
Doses / concentrations
Remarks:
Doses / Concentrations:
2000 mg/kg bw/day
Basis:
actual ingested
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Positive control(s):
Clyclophosphamide

Examinations

Tissues and cell types examined:
bone marrow

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid

Any other information on results incl. tables

Mice were treated with Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts at dose of 2000 mg/kg bw for two consecutive days.

All animals survived and no signs of toxicity were observed.

The dissection of the animals revealed no test substance related macroscopic findings. The bone marrow smears were examined for the occurrence of micronuclei in red blood cells.

The incidence of micronucleated polychromatic erythrocytes was within the normal range of the negative control groups. No statisticallysignificant increase of micronucleated polychromatic erythrocytes was observed.

The ratio of polychromatic erythrocytes to total erythrocytes remained essentiallyunaffected by the test compound and was not less than 20% of the control values.

Cyclophosphamide induced a marked and statistically significant increase in the number of polychromatic erythrocytes with micronuclei, thus indicating the sensitivity of the test system.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts did not induce clastogenic effect on the bone marrow cells in mice.
Executive summary:

Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts was investigated for its clastogenic potential according to the OECD Guideline 474. Mice were treated at dose of 2000 mg/kg bw for two consecutive days. No clastogenic effect was found in bone marrow cells and no effect on the ratio of polychromatic erythrocytes to total erythrocytes.

Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts is considered to be a non-clastogenic compound.