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Toxicological information

Toxicity to reproduction: other studies

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Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data meet generally accepted scientific principles with the following restriction: only basic data available from short information on the study, no information on test protocol available

Data source

Reference
Reference Type:
other: short information
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Principles of method if other than guideline:
Uterotrophic assay: uterus weights as indicator of estrogen-like activity
GLP compliance:
not specified
Type of method:
in vivo

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Citral
- Lot/batch No.: 80-0087

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: unspecified
Duration of treatment / exposure:
3 d
Frequency of treatment:
daily
Duration of test:
3d
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 300, 1000 mg/kg bw/d
Basis:

No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
Positive control: DES-DP (5 µg/kg bw/day)
Statistics:
Dunnett's test

Results and discussion

Observed effects

Clinical findings: nothing abnormal detected
Uterus weight: The significant reduction of uterus weights in case of 1000 mg citral/kg bw treatment was judged as not biologically relevant. The sensitivity of the rats was demonstrated by the induced estrogen-like effect with the positive control substance DES-DP.

Any other information on results incl. tables

Table 1: Test results from uterotrophic assay

Group

Negative control

Positive control (DES-DP) µg/kg

Citral mg/kg bw/day

Dose

0

5

300

1000

Animal numbers

10

10

10

10

Clinical findings

NAD

NAD

NAD

NAD

Body weight gain (g)

14.5

14.1

14.3

13.3

Uterus weight

   absolute (g)

0.039

0.120**

0.036

0.033*

   relative (%)

0.069

0.219

0.065

0.061

* p≤0.05; ** p≤0.01 (Dunnett-test)

NAD: nothing abnormal detected

Applicant's summary and conclusion