Registration Dossier

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Remarks:
based on test type (migrated information)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Japanese study, tables and results are available in english, narrative part not translated

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
Deviations:
not specified
GLP compliance:
not specified
Remarks:
GLP compliance expected

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: gum arabicum
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
up to 28 consecutive days
Frequency of treatment:
once daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 2.2, 25, 250 mg/kg/day
Basis:
nominal conc.
No. of animals per sex per dose:
15 (control and high dose groups)
10 (low and mid dose groups)
Control animals:
yes, concurrent vehicle

Examinations

Parental animals: Observations and examinations:
clinical observations, body weight, food consumption, clinical pathology
Oestrous cyclicity (parental animals):
no
Sperm parameters (parental animals):
general histopathologic testes investigation
Litter observations:
basic analysis
Postmortem examinations (parental animals):
organ weights, histopathologic examinations
Postmortem examinations (offspring):
none
Reproductive indices:
implantation and gestation indices, live birth index
Offspring viability indices:
numbers, sex ratio, viability index

Results and discussion

Results: P0 (first parental animals)

Details on results (P0)

The following effects occurred in males only: Increase in album, in A/G ratio, decrease in alpha-2-globuline, beta-globuline as well as increase in absolute and relative liver weight. The liver weight increase showed a clear trend towards reversibility but was not completely reversible after the 14-day recovery period.

Effect levels (P0)

open allclose all
Dose descriptor:
NOEL
Effect level:
2.5 mg/kg bw/day
Based on:
test mat.
Sex:
male
Basis for effect level:
other: liver weight increase and imbalance of protein pattern
Dose descriptor:
NOAEL
Effect level:
250 mg/kg bw/day
Based on:
test mat.
Sex:
female
Basis for effect level:
other: reproductive parameters

Results: F1 generation

Details on results (F1)

No adverse findings detected.

Effect levels (F1)

Dose descriptor:
NOEL
Generation:
F1
Effect level:
250 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: developmental parameters

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion