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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Toxicity to reproduction

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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)

Data source

Reference
Reference Type:
other: Inquiry result from ECHA
Title:
Unnamed
Year:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
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:
Hill formula: C14 H28 N2 O6
IUPAC Name:
N,N,N',N'-tetrakis(2-hydroxyethyl)hexanediamide

Test animals

Species:
rat
Strain:
other: Crl:CD BR

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: diet
Details on exposure:
Method of administration or exposure: incorporation into the diet
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

Results and discussion

Results: P0 (first parental generation)

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.

Results: F1 generation

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.

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

Refer to the overall remarks, attachment section

Applicant's summary and conclusion