Hexamethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian germ cell study: cytogenicity / chromosome aberration

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978-07-10 to 1978-09-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Non GLP but guideline compliant study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)

Version / remarks:

1984

Deviations:

no

GLP compliance:

no

Type of assay:

rodent dominant lethal assay

Test material

Test material information

Constituent 1

Reference substance name:

Hexamethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]

EC Number:

252-346-9

EC Name:

Hexamethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]

Cas Number:

35074-77-2

Molecular formula:

C40H62O6

IUPAC Name:

6-{[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}hexyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate

Test animals

Species:

mouse

Strain:

Tif:MAGf

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: closed SPF breeding colony
- Age at study initiation: males: 2 - 6 months; females: 2 months
- Diet ad libitum, standard diet (NAFAG No. 890)
- Water: ad libitum, tap water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±1
- Humidity (%): 60±5
- Photoperiod: Room was illuminated for 10 hours daily.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

- Vehicle used: CMC (carboxymethyl cellulose)
- Amount of vehicle: 0.2 mL/10 g body weight

Duration of treatment / exposure:

Single treatment

Frequency of treatment:

once

Post exposure period:

No

Doses / concentrations

Remarks:

Doses / Concentrations:
1000, 3000 mg/kg bw
Basis:
nominal conc.

No. of animals per sex per dose:

20 males per dosing group
240 females per dosing group

Control animals:

yes, concurrent vehicle

Positive control(s):

none

Examinations

Evaluation criteria:

The experiment was done to evaluate any cytotoxic or mutagenic effects on the male germinal cells as expressed by the loss of pre-implantation zygotes as well as by the rate of deaths of post-implantation stages of embryonic development.

Statistics:

To compare the totals of the number of implantations - indicating possible pre-implantation losses - Student's t test or Mann-Whitney' U-test was used. The totals of the numbers of mated and pregnant dams or embryonic deaths were compared with the aid of the chi-square-test or Fisher's exact test.

Results and discussion

Test results

Sex:

male

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

not examined

Additional information on results:

The females mated to males which had been treated with the compound did not differ significantly from the females mated to control, neither in mating ratio nor in the number of implantations and embryonic deaths (resorptions). No evidence of dominant lethal effect was observed in the progeny of male mice treated with the test article.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative