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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
fertility, other
Remarks:
based on test type (migrated information)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
1953
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable published study, basic data given.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Toxicity of butyl stearate, dibutyl sebacate, dibutyl phthalate, and methoxyethyl oleate
Author:
Smith, C.C.
Year:
1953
Bibliographic source:
Archives of Industrial Hygiene and Occupational Medicine, 1953
Reference Type:
secondary source
Title:
Final report on the safety assessment of Butyl stearate, Cetyl stearate, Isobutyl stearate, Isocetyl stearate, Isopropyl stearate, Myristyl stearate, and Octyl stearate
Author:
Busch J.T.
Year:
1985
Bibliographic source:
J Am College of Toxicol 4: 107-146
Reference Type:
secondary source
Title:
Palmitic Acid 2-ethylhexyl Esters Category of the Aliphatic Esters Chemicals (Test Plan and Robust Summaries for Substances in the HPV Test Plan)
Author:
US-EPA (American Chemistry Council’s Aliphatic Esters Panel)
Year:
2010
Bibliographic source:
High Production Volume (HPV) Chemical Challenge Program (201-16834B and 201-14977E)

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Groups of 20 male and female rats were treated during 10 weeks with the test item at a concentration of 6.25% in diet and were then mated. F1 animals were also treated post weaning and sacrificed at day 21 post weaning.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: (P) 5-6 weeks
- Weight at study initiation: Control group: (F1) Males: 44 ± 8 g; Females: 43 ± 9 g; Treatment group: (F1) Males: 39 ± 6 g; Females: 37 ± 6 g

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Details on mating procedure:
- After successful mating each pregnant female was caged: Pregnant females were transferred to individual breeding cages.
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
(P) Males and Females: 10 weeks before mating
(F1) 24 males and 24 females were chosen at random and 21 days post partum fed the same diet
Frequency of treatment:
Parental animals:
Daily for 10 weeks

F1 animals:
Daily for 21 days post partum
Details on study schedule:
- Parental animals were fed diets containing 6.25% test substance for 10 weeks and mated. A control group of 12 male and 12 female animals of the same age were fed the basal ratio for 10 weeks and mated.
- Litters were weaned 21 days post partum.
- 24 male and 24 female litters were chosen at random and 21 days post partum fed the same diet as had been ingested by their parents.
Doses / concentrations
Remarks:
Doses / Concentrations:
6.25%
Basis:
nominal in diet
corresponding to about 6000 mg/kg bw/day
No. of animals per sex per dose:
Parental animals:
Control group: 12 males and 12 females
Treatment group: 20 males and 20 females

F1 animals:
Treatment group: 24 males and 24 females
Control animals:
yes, plain diet

Examinations

Parental animals: Observations and examinations:
Examination of parental animals was focused on fertility.
Litter observations:
The following parameters were examined in [F1] offspring: number and sex of pups, litter size, survival of offspring, body weight (daily), weight gain.

Postmortem examinations (parental animals):
Not specified.
Postmortem examinations (offspring):
The F1 offspring were sacrificed 21 days after weaning and and were subjected to postmortem examinations.


Results and discussion

Results: P0 (first parental animals)

Reproductive function / performance (P0)

Reproductive performance:
no effects observed

Details on results (P0)

No adverse effects were noted between control and treatment groups.
No adverse effects were noted with respect to fertility.

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
ca. 6 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No adverse effects were noted with respect to fertility.

Results: F1 generation

General toxicity (F1)

Mortality / viability:
no mortality observed
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
non-adverse
Sexual maturation:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
no effects observed
Histopathological findings:
not specified

Details on results (F1)

No adverse effects were noted between control and treatment groups.
No adverse effects were found with respect to litter size of offspring. Only the growth was significantly retarded during the preweaning and postweaning periods.
No gross lesions were found among the animals at sacrifice at the end of the 21-day postweaning period.

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
ca. 6 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: see 'Remark'

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

Table 1: Summary of effects of butyl stearate on reproduction and growth of offspring in the rat

Substance in diet, %

No. of females

No. of rats per litter

Mean weight at weaning ± deviation [g]

Mean weight gain 21 days after weaning ± deviation [g]

In group

Bearing young

At birth

At weaning (21 days)

mean

range

mean

range

male

female

male

female

None

12

12

9.6

6-12

8.8

6-11

44±8

43±9

110±15

96±10

6.25

20

20

10.5

3-11

9.3

3-11

39±6*

37±6 t

101±10*

86±7 **

* P = > 0.01 < 0.05

** P = < 0.01

Applicant's summary and conclusion