Registration Dossier
Registration Dossier
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EC number: 201-854-9 | CAS number: 88-73-3
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Highest dose was too high; only summary available
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Reference Type:
- other: OECD SIDS
- Title:
- Unnamed
- Year:
- 2 001
- Reference Type:
- other: US EPA Status Report
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 25 females/group, due to severe maternal toxicity and mortality the 150 mg/kg bw/day level was terminated prior to scheduled sacrifice.
- GLP compliance:
- yes
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Purity: commercial
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- days 6-15 of gestation
- Duration of test:
- 21 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 25, 75, 150 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 25 females/dose
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Details on maternal toxic effects:
Mortality:
At 150 mg/kg all dams were terminated prior to scheduled sacrifice because of severe toxicity and high mortality
At 75 mg/kg 1 dam died.
General toxicity:
At 75 mg/kg: between gestation days 6-10 reduced body weight gain (slight but not significant) and reduced food consumption; recovery later in gestation; urinary staining, alopecia; maternal reproductive parameters comparable to controls, mean number of early resorptions and post implantation loss slightly increased (post implantation loss in the respective control very low compared to historical control; values range: 0-0.9).
At 25 mg/kg: no evidence of maternal toxicity.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 25 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
Fetal body weight comparable to control.
Variations: cervical #7 ribs at 25 mg/kg bw/day (1.1%) and significant at 75 mg/kg (2%); 13 full pairs of ribs with lumbar #1 rudimentary ribs in controls, at 25 mg/kg, 75 mg/kg increased, but not significant; 12 full pair of ribs with #13 unilateral full rib and/or rudimentary rib(s) in controls and in 25 mg/kg increased, but not significant
A NOAEL for developmental toxicity could not be conclusively derived.
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.
