Registration Dossier

Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

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

Constituent 1
Chemical structure
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