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Toxicological information

Developmental toxicity / teratogenicity

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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:
other: OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
GLP compliance:
yes (incl. certificate)
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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)

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (actual dose received)
Basis for effect level:
other: developmental toxicity
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

Applicant's summary and conclusion