1,1',1'',1'''-ethylenedinitrilotetrapropan-2-ol

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and gudeline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)

GLP compliance:

yes (incl. QA statement)

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,1',1'',1'''-ethylenedinitrilotetrapropan-2-ol

EC Number:

203-041-4

EC Name:

1,1',1'',1'''-ethylenedinitrilotetrapropan-2-ol

Cas Number:

102-60-3

Molecular formula:

C14H32N2O4

IUPAC Name:

1-({2-[bis(2-hydroxypropyl)amino]ethyl}(2-hydroxypropyl)amino)propan-2-ol

Details on test material:

- Name of test material (as cited in study report): Quadrol Polyol N,N,N`,N`-Tetrakis (2-Hydroxylpropyl) Ethylenediamine, Tetrahydroxypropylethylenediamine
- Physical state: viscous / colorless, clear liquid
- Analytical purity: 100.1 %
- Lot/batch No.: WPTB612C
- Date of production: 2006-06-22
- Storage condition of test material: ambient (room temperature); under N2

Test animals

Species:

rat

Strain:

Wistar

Details on test animals or test system and environmental conditions:

For details see endpoint record "toxicity to reproduction"

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on exposure:

For details see endpoint record "toxicity to reproduction"

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

For details see endpoint record "toxicity to reproduction"

Details on mating procedure:

For details see endpoint record "toxicity to reproduction"

Duration of treatment / exposure:

For details see endpoint record "toxicity to reproduction"

Frequency of treatment:

For details see endpoint record "toxicity to reproduction"

Duration of test:

For details see endpoint record "toxicity to reproduction"

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 100, 300, 1000 mg/kg bw
Basis:
actual ingested

No. of animals per sex per dose:

10 males/ 10 females

Control animals:

yes, concurrent vehicle

Details on study design:

For details see endpoint record "toxicity to reproduction"

Examinations

Maternal examinations:

For details see endpoint record "toxicity to reproduction"

Ovaries and uterine content:

For details see endpoint record "toxicity to reproduction"

Fetal examinations:

For details see endpoint record "toxicity to reproduction"

Statistics:

For details see endpoint record "toxicity to reproduction"

Indices:

For details see endpoint record "toxicity to reproduction"

Historical control data:

For details see endpoint record "toxicity to reproduction"

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Details on maternal toxic effects:
For details see endpoint record "toxicity to reproduction"

Effect levels (maternal animals)

1

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day (actual dose received)

Basis for effect level:

other: developmental toxicity

2

Dose descriptor:

NOAEL

Effect level:

300 mg/kg bw/day (actual dose received)

Basis for effect level:

other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
For details see endpoint record "toxicity to reproduction"

Effect levels (fetuses)

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: no effects observed

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified