N,N,N',N'-tetrakis(2-hydroxyethyl)hexanediamide

Toxicity to reproduction

Administrative data

Endpoint:

one-generation reproductive toxicity

Remarks:

based on test type (migrated information)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Tests conducted by a trusted laboratory.

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD 415 (1983)

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

405-370-0

EC Name:

-

Cas Number:

6334-25-4

Molecular formula:

C14H28N2O6

IUPAC Name:

N,N,N',N'-tetrakis(2-hydroxyethyl)hexanediamide

Test material form:

solid: particulate/powder

Test animals

Species:

other: rat Crl: CD BR

Strain:

CD-1

Sex:

male/female

Administration / exposure

Route of administration:

oral: unspecified

Type of inhalation exposure (if applicable):

not specified

Vehicle:

other: diet (P.M.I. Certified Rodent Diet #5002M)

Details on exposure:

Method of administration or exposure: in feed

Frequency of treatment:

Dosing regime (males): 7 days/week
Dosing regime (females): 7 days/week

No. of animals per sex per dose:

Male: 30 animals at 0 mg/kg or mg/l
Male: 30 animals at 63 mg/kg or mg/l
Male: 30 animals at 284 mg/kg or mg/l
Male: 30 animals at 1280 mg/kg or mg/l
Female: 30 animals at 0 mg/kg or mg/l
Female: 30 animals at 86 mg/kg or mg/l
Female: 30 animals at 388 mg/kg or mg/l
Female: 30 animals at 1727 mg/kg or mg/l

Control animals:

not specified

Details on study design:

Number of litters per dose/conc.: 25 at mg/kg or mg/l

Examinations

Parental animals: Observations and examinations:

The only sign of toxicity related to treatment was soft
and/or irregularfaeces observed in 24/30 males during the
post mating period, i.e. after 11 weeks treatment, and in
females only during the premating period beginning after 6-7
dosing. No treatment related effects on fertility were
observed. On the basis of these results the NOAEL for
general toxicity is considered to be 284 mg/kg/day for males
and 388 mg/kg/day for females and that for fertility is 1280
mg/kg/day for males and 1727 mg/kg/day for females .

Postmortem examinations (offspring):

Effects on F1 generation:
No treatment-related effects were seen at any dose level.
The NOAEL for developmental effects is therefore considered
to be 1727 mg/kg/day.

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:

not specified

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:

not specified

Reproductive function: sperm measures:

not specified

Reproductive performance:

not specified

Details on results (P0)

The only sign of toxicity related to treatment was soft
and/or irregularfaeces observed in 24/30 males during the
post mating period, i.e. after 11 weeks treatment, and in
females only during the premating period beginning after 6-7
dosing. No treatment related effects on fertility were
observed. On the basis of these results the NOAEL for
general toxicity is considered to be 284 mg/kg/day for males
and 388 mg/kg/day for females and that for fertility is 1280
mg/kg/day for males and 1727 mg/kg/day for females .

Effect levels (P0)

Key result

Dose descriptor:

NOAEL

Effect level:

ca. 20 000 ppm

Based on:

test mat.

Sex:

male

Basis for effect level:

body weight and weight gain

Results: P1 (second parental generation)

General toxicity (P1)

Dermal irritation (if dermal study):

not specified

Results: F1 generation

General toxicity (F1)

Clinical signs:

not specified

Details on results (F1)

Effects on F1 generation:
No treatment-related effects were seen at any dose level.
The NOAEL for developmental effects is therefore considered
to be 1727 mg/kg/day.

Effect levels (F1)

Key result

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

ca. 20 000 ppm

Based on:

not specified

Sex:

male/female

Basis for effect level:

body weight and weight gain

Overall reproductive toxicity

Reproductive effects observed:

not specified

Any other information on results incl. tables

Details on results (parental animals )

The only sign of toxicityrelated to treatment was soft and/or irregularfaeces observed in 24/30 males during the post mating period, i.e. after 11 weekstreatment,and in females only during the premating period beginning after 6-7 dosing.No treatment related effeds on fertility were observed.On the basis of these results the NOAEL for general toxicity is considered to be 284 mg/kg/day for males
and 388 mg/kg/day for females and that for fertilityis1280 mg/kg/day for males and 1727 mglkg/day for females.

Details of results (offspring)

Effects on F1 generation:

No treatment-related effects were seen at any dose level.
The NOAELfordevelopmental effects is therefore considered
to be 1727 mg/kg/day.

Applicant's summary and conclusion

Executive summary:

The information provided for this end point is based on the SNIF#001 -4.4.20 -01 which was supplied by ECHA together with the letter dated September 04 , 2013. This letter is a reply to our request for additional information. Submission number AM431058 -44 . Communication nbr INQ-C-2114259180 -56 -01/F

Input date: 27.03.2014