Registration Dossier
Registration Dossier
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EC number: 205-355-7 | CAS number: 139-13-9
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1971
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Title:
- No information
- Author:
- Anonymous
- Year:
- 2 000
- Bibliographic source:
- IUCLID4 data set for trisodiumnitrilotriacetate, 18 February 2000, page 244-245 and 247-248
Materials and methods
Test guideline
- Guideline:
- other: Procter & Gamble (USA)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Nitrilotriacetic acid
- EC Number:
- 205-355-7
- EC Name:
- Nitrilotriacetic acid
- Cas Number:
- 139-13-9
- Molecular formula:
- C6H9NO6
- IUPAC Name:
- 2-[bis(carboxymethyl)amino]acetic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles River CD
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- pre-mating exposure period: 8 weeks for male and female
exposure period during pregnancy: from day 6 through day 15 - Frequency of treatment:
- continuous
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.1% and 0.5% (50 and 250 mg/kg bw per day as Na3NTA.H2O
Basis:
nominal in diet
- No. of animals per sex per dose:
- 20 animals per dose per sex
20 animals per sex for control - Control animals:
- yes, concurrent no treatment
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
F1+F2: There were no effects on number of corpora lutea, resorptions and implantations (on day 13); conception, live and dead foetuses, weight of
foetuses, gross and microscopic inspection of organs for abnormalities (day 21).
Conception varied from 86% (F2) to 97% (F1), with control 92-95%.
See for further details the in section 13 attached IUCLID4 data set.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- > 175 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Effect level expressed as the acid
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- > 175 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Effect level expressed as the acid
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- > 175 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Effect level expressed as the acid
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
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