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Toxicological information

Genetic toxicity: in vivo

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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well-documented journal article.

Data source

Reference
Reference Type:
publication
Title:
The cytogenetic studies and dominant lethal tests of long term administration with butylated hydroxytoluene (BHT) and linear alkylbenzene sulfonate (LAS) in mice and rats.
Author:
Masubuchi, M, Takahashi, A, Takahashi, O and Hiraga, K
Year:
1976
Bibliographic source:
Masubuchi et. al.,1976. The cytogenetic studies and dominant lethal tests of long term administration with butylated hydroxytoluene (BHT) and linear alkylbenzene sulfonate (LAS) in mice and rats. Ann. Rep. Tokyo Metrop. Res. Lab. Public Health, 27, 100-4.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A group of 7 male mice was fed a diet containing 0.6% test substance for 9 months. At the end of this period, the animals were each mated with two untreated females. On day 13 of pregnancy, the females were sacrificed, and the ovaries and uteri were examined.
GLP compliance:
no
Type of assay:
rodent dominant lethal assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): linear alkylbenzene sulfonate

Test animals

Species:
mouse
Strain:
other: JCL-ICR
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CLEA Japan, Inc.
- Age at study initiation: 4 weeks
- Housing: individually, except during breeding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 +/- 1
- Humidity (%): 55 +/- 5
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: feed
Details on exposure:
DIET PREPARATION
- Mixing appropriate amounts with (Type of food): feed powder CE-2
Duration of treatment / exposure:
9 months
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0.6%, 300 mg/kg bw d
Basis: nominal in diet
No. of animals per sex per dose:
7
Control animals:
yes

Examinations

Statistics:
Rohrborn's method.

Results and discussion

Test results
Key result
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Negative controls validity:
valid
Additional information on results:
There were no significant differences in fertility, the mortality of ova and embryos, the number of surviving fetuses, or the index of dominant lethal induction between the experimental groups and the control group.

Any other information on results incl. tables

Dominant Lethal Assay Results

 

0.6% in Diet

Control

Number of mating females

14

18

Number pregnant

11

12

No. with dead embryos

6

10

Dead embryos per pregnant female

54.6%

83.3%

No. of corpora lutea

156

161

Corpora lutea per pregnant female

14.2

13.4

No. of implants

148

156

Implants per pregnant female

13.5

13.0

Implants per corpora lutea

94.9

96.9

No. of live fetuses

142

143

Live fetuses per pregnant female

12.9

11.9

Live fetuses per corpora lutea

91.0

88.8

Live fetuses per total implants

96.0

91.7

No. of early dead fetuses

4

12

No. of late dead fetuses

2

1

% of dominant lethals

-4.67

-

% of dominant lethals

-8.33

-

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative
The test substance did not cause genetic disorders in mice.
Executive summary:

A group of 7 male mice was fed a diet containing 0.6% test substance for 9 months. At the end of this period, the animals were each mated with two untreated females. On day 13 of pregnancy, the females were sacrificed, and the ovaries and uteri were examined. No increase in dominant lethal induction was seen as compared to controls. The test substance does not cause genetic disorders.