Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test).
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD TG 422
GLP compliance:
yes (incl. certificate)
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
cf. Chapter 7.8.1: DocRefPK IUC5-993621ca-b18c-47ca-983e-788754484e1f/0

Test animals

Species:
rat
Strain:
other: Crl.WI (Han)
Details on test animals and environmental conditions:
cf. Chapter 7.8.1: DocRefPK IUC5-993621ca-b18c-47ca-983e-788754484e1f/0

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.25% aqueous hydroxypropyl methylcellulose (Methocel® K4M Premium)
Details on exposure:
cf. Chapter 7.8.1: DocRefPK IUC5-993621ca-b18c-47ca-983e-788754484e1f/0
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
cf. Chapter 7.8.1: DocRefPK IUC5-993621ca-b18c-47ca-983e-788754484e1f/0
Details on mating procedure:
cf. Chapter 7.8.1: DocRefPK IUC5-993621ca-b18c-47ca-983e-788754484e1f/0
Duration of treatment / exposure:
cf. Chapter 7.8.1: DocRefPK IUC5-993621ca-b18c-47ca-983e-788754484e1f/0
Frequency of treatment:
cf. Chapter 7.8.1: DocRefPK IUC5-993621ca-b18c-47ca-983e-788754484e1f/0
Duration of test:
cf. Chapter 7.8.1: DocRefPK IUC5-993621ca-b18c-47ca-983e-788754484e1f/0
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 15, 45, 135 mg/kg bw
Basis:
actual ingested
No. of animals per sex per dose:
cf. Chapter 7.8.1: DocRefPK IUC5-993621ca-b18c-47ca-983e-788754484e1f/0
Control animals:
yes, concurrent vehicle
Details on study design:
cf. Chapter 7.8.1: DocRefPK IUC5-993621ca-b18c-47ca-983e-788754484e1f/0

Examinations

Maternal examinations:
cf. Chapter 7.8.1: DocRefPK IUC5-993621ca-b18c-47ca-983e-788754484e1f/0
Ovaries and uterine content:
cf. Chapter 7.8.1: DocRefPK IUC5-993621ca-b18c-47ca-983e-788754484e1f/0
Fetal examinations:
cf. Chapter 7.8.1: DocRefPK IUC5-993621ca-b18c-47ca-983e-788754484e1f/0
Statistics:
cf. Chapter 7.8.1: DocRefPK IUC5-993621ca-b18c-47ca-983e-788754484e1f/0
Indices:
cf. Chapter 7.8.1: DocRefPK IUC5-993621ca-b18c-47ca-983e-788754484e1f/0
Historical control data:
cf. Chapter 7.8.1: DocRefPK IUC5-993621ca-b18c-47ca-983e-788754484e1f/0

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:yes. Remark: cf. Chapter 7.8.1: DocRefPK IUC5-993621ca-b18c-47ca-983e-788754484e1f/0

Details on maternal toxic effects:
cf. Chapter 7.8.1: DocRefPK IUC5-993621ca-b18c-47ca-983e-788754484e1f/0

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
15 mg/kg bw/day (actual dose received)
Based on:
test mat.
Basis for effect level:
other: other:

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Details on embryotoxic / teratogenic effects:
cf. Chapter 7.8.1: DocRefPK IUC5-993621ca-b18c-47ca-983e-788754484e1f/0

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
cf. Chapter 7.8.1: DocRefPK IUC5-993621ca-b18c-47ca-983e-788754484e1f/0
Executive summary:

cf. Chapter 7.8.1: DocRefPK IUC5-993621ca-b18c-47ca-983e-788754484e1f/0