Registration Dossier
Registration Dossier
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EC number: 203-041-4 | CAS number: 102-60-3
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:
- 2 009
- 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
- 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
Constituent 1
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)
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
