Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 226-887-6 | CAS number: 5534-13-4
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 2014
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study based on read-across from old data, but considered reliable in a weight of evidence approach.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Teratology Studies on betamethasone 17,21-dipropionate, prednisolone and betamethasone 21-disodium phosphate in mice and rats
- Author:
- Hasegawa, Y. at al.
- Year:
- 1 974
- Bibliographic source:
- Oyo Yakuri (Pharmacometrics), 1974, 8(6)
Materials and methods
- GLP compliance:
- no
- Type of method:
- in vivo
Test material
- Reference substance name:
- betamethasone 17,21-dipropionate
- IUPAC Name:
- betamethasone 17,21-dipropionate
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- female
Administration / exposure
- Route of administration:
- subcutaneous
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Dosed for six days starting on day 7 of gestation.
- Frequency of treatment:
- Daily injections.
- Duration of test:
- Dams were killed on day 18 and C-sectioned.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0
Basis:
nominal conc.
mg/kg/day
- Remarks:
- Doses / Concentrations:
0.156
Basis:
nominal conc.
mg/kg/day
- Remarks:
- Doses / Concentrations:
0.625
Basis:
nominal conc.
mg/kg/day
- Remarks:
- Doses / Concentrations:
2.5
Basis:
nominal conc.
mg/kg/day
- No. of animals per sex per dose:
- 23 in 156 mg/kg/day group, 22 in 0.625 and 2.5 mg/kg/day dose groups
- Control animals:
- yes
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- other: Body weight of live fetuses
- Effect level:
- >= 0.156 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: Significantly reduced in all treatment groups.
- Dose descriptor:
- other: Number of live fetuses on C-sectioned
- Effect level:
- >= 0.625 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: Significantly reduced in mid and high-dose groups. 90%, 87%, 75%, and 18% at 0, 0.156, 0.625, and 2.5 mg/kg/day, respectively.
- Dose descriptor:
- other: Number of resorbed fetuses
- Effect level:
- >= 0.625 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: Significantly increased in mid and high-dose groups. 10%, 10%, 15%, and 71% at 0, 0.156, 0.625, and 2.5 mg/kg/day, respectively.
- Dose descriptor:
- other: Number of "macerated" fetuses
- Effect level:
- >= 0.625 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: Significantly increased in mid and high-dose groups. 0%, 2%, 6%, and 8% at 0, 0.156, 0.625, and 2.5 mg/kg/day, respectively.
- Dose descriptor:
- other: Number of dead fetuses
- Effect level:
- >= 0.625 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: Significantly increased in mid and high-dose groups. 0%, 1%, 4%, and 4% at 0, 0.156, 0.625, and 2.5 mg/kg/day, respectively.
- Dose descriptor:
- other: cleft palate anomalies
- Effect level:
- >= 0.156 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: Significantly increased in all treatment groups. 2%, 12%, 45%, and 96% at 0, 0.156, 0.625, and 2.5 mg/kg/day, respectively.
- Dose descriptor:
- other: Crooked or short tail
- Effect level:
- >= 2.5 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: Significantly increased in high-dose group. 0%, 1%, 1%, and 20% at 0, 0.156, 0.625, and 2.5 mg/kg/day, respectively.
Any other information on results incl. tables
A NOAEL was not observed as fetal toxicity was observed at the lowest exposure that was evaluated.
Applicant's summary and conclusion
- Conclusions:
- Because betamethasone 17-propionate is structurally related to betamethasone 17,21-dipropionate, as biological main metabolite, should be considered having developmental toxicity.
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.
