Registration Dossier
Registration Dossier
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EC number: 204-289-6 | CAS number: 118-96-7
Developmental toxicity / teratogenicity
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- Oral route, rat or rabbit
- Deviations:
- yes
- Remarks:
- In the Study plan, it was assumed female fertilisation by insemination, however in the premilinary stage of the test it was decided to introduce fertilization by method of male mating. The change does not affectthe test results.
Test material
- Test material form:
- solid: flakes
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Administration / exposure
- Route of administration:
- oral: gavage
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 45 mg/kg bw/day
- Basis for effect level:
- food consumption and compound intake
- water consumption and compound intake
- Dose descriptor:
- LOAEL
- Effect level:
- > 160 mg/kg bw/day
- Basis for effect level:
- body weight and weight gain
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 10 mg/kg bw/day
- Basis for effect level:
- food consumption and compound intake
- water consumption and compound intake
Maternal abnormalities
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- uterus
- Description (incidence and severity):
- the weight of the pregnant uterus showed a statistically significant decrease of 39.5% compared to the control group in the case of animals in the 160 mg/kg b.w.
Results (fetuses)
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 160 mg/kg bw/day
- Basis for effect level:
- other: Viable fetuses
- Dose descriptor:
- NOAEL
- Effect level:
- 45 mg/kg bw/day
- Basis for effect level:
- other: Viable fetuses
- Dose descriptor:
- LOAEL
- Effect level:
- > 160 mg/kg bw/day
- Basis for effect level:
- other: Number of corpora lutea
- Dose descriptor:
- LOAEL
- Effect level:
- > 160 mg/kg bw/day
- Basis for effect level:
- other: Average number of embryonic deaths
- Dose descriptor:
- LOAEL
- Effect level:
- 45 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- fetal/pup body weight changes
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 10 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- fetal/pup body weight changes
Fetal abnormalities
open allclose all
- Abnormalities:
- effects observed, non-treatment-related
- Localisation:
- other: Developmental alterations in osteochondral system
- Description (incidence and severity):
- Parcial or no ossification of 5 bones of sternum and xiphoid cartilage
- Abnormalities:
- no effects observed
- Localisation:
- other: Developmental defects in osteochondral system
- Abnormalities:
- no effects observed
- Localisation:
- other: Changes in soft tissue and encephalon
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
As no developmental disorders were found, this may suggest a mechanism related to maternal toxicity of the 2,4,6-trinitrotoluene.
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.
