3,9-bis(2,4-di-tert-butylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

Toxicity to reproduction

Administrative data

Endpoint:

one-generation reproductive toxicity

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]

Deviations:

yes

Remarks:

only two doses used; only 15 animals per dose used, reporting details

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,9-bis(2,4-di-tert-butylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

EC Number:

247-952-5

EC Name:

3,9-bis(2,4-di-tert-butylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

Cas Number:

26741-53-7

Molecular formula:

C33H50O6P2

IUPAC Name:

3,9-bis(2,4-di-tert-butylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

Details on test material:

no further data provided

Specific details on test material used for the study:

- Name of test material (as cited in study report): Weston XP 1452

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: animals weighing about 50 g
- Housing: two animals per cage

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 - 26

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Details on exposure:

PREPARATION OF DOSING SOLUTIONS:
It was preferred to use the product in conditions close to its utilization, i.e. being heated in plastics. For practical mixing reasons and for technical reasons, the product was mixed with the food which was shaped into small biscuits in accordance with the normal preparation technique for rats' diets; the product was therefore heated.

Details on mating procedure:

The animals were mated at the rate of 8 males selected at random from each group for 15 females from each group. After 3 weeks, the females were separated and placed in individual cages. At birth, the number of young per litter was counted and each litter was weighed and days 1, 10 and 20. The young were examined for any possible malformation of limbs or palate or hydrocephalus.

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

12 weeks

Frequency of treatment:

daily

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

100 ppm

Doses / concentrations 2

Dose / conc.:

500 ppm

No. of animals per sex per dose:

15

Control animals:

yes, plain diet

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:

no effects observed

Dermal irritation (if dermal study):

not examined

Mortality:

no mortality observed

Description (incidence):

No mortality in any case of treated or untreated animals was observed.

Body weight and weight changes:

no effects observed

Description (incidence and severity):

Growth was normal.

Food consumption and compound intake (if feeding study):

not examined

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

not examined

Clinical biochemistry findings:

not examined

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Immunological findings:

not examined

Organ weight findings including organ / body weight ratios:

not examined

Histopathological findings: non-neoplastic:

not examined

Histopathological findings: neoplastic:

not examined

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:

not examined

Reproductive function: sperm measures:

not examined

Description (incidence and severity):

The number of gravid females was identical in the control group and the treated group receiving food containing 100 ppm of the test substance. However, we noted a reduction in fertility of 20% in the case of the diet containing 500 ppm of test substance, although the results are bordering on insignificance.

Effect levels (P0)

1

Dose descriptor:

NOAEL

Effect level:

100 ppm

Based on:

test mat.

Sex:

female

Basis for effect level:

other: no adverse findings

2

Dose descriptor:

LOAEL

Effect level:

500 ppm

Based on:

test mat.

Sex:

female

Basis for effect level:

reproductive performance

Results: F1 generation

General toxicity (F1)

Clinical signs:

no effects observed

Dermal irritation (if dermal study):

not examined

Mortality / viability:

not examined

Body weight and weight changes:

effects observed, treatment-related

Description (incidence and severity):

The weight of the young was reduced at 500 ppm.

Food consumption and compound intake (if feeding study):

not examined

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

not examined

Clinical biochemistry findings:

not examined

Urinalysis findings:

not examined

Sexual maturation:

not examined

Organ weight findings including organ / body weight ratios:

not examined

Gross pathological findings:

not examined

Histopathological findings:

not examined

Developmental neurotoxicity (F1)

Behaviour (functional findings):

not examined

Developmental immunotoxicity (F1)

Developmental immunotoxicity:

not examined

Details on results (F1)

Whilst the number of young per litter is the same for the first two groups, it is 10% less in the last group. We did not observe any difference in the average weight of the young on days 1, 10 and 20. The ratio between males and females differs from group to group and is particularly marked between the control group and the group treated with 500 ppm, this last group having a lower number of females. lt is difficult to judge the significance of these results, because in our conditions we often see variations of over 10% in sex distribution among animals not having received any treatment; we have therefore disregarded this result.

Effect levels (F1)

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

500 ppm

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: no adverse finding at this level

Overall reproductive toxicity

Reproductive effects observed:

not specified