Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: other route
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
study period 4 days
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: pilot study, non-GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Principles of method if other than guideline:
The purpose of the study was to evaluate the effect of 4-HBA to immature female mice when administered by subcutaneous injection for 3 consecutive days. This study is a dose-setting study for a subsequent uterotrophic assay in immature mice.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
preformulated test substance was delivered to the lab.

The details listed below refer to the test substance, not the formulated product:
- Name of test material (as cited in study report): 4-hydroxybenzoic acid
- Source: NIPA Laboratories
- Batch reference number: 4110J082
- Purity: 99.52%
- Colour: white
- Physical state: Powder
- Expiry: 11/07/2001

Test animals

Species:
mouse
Strain:
CD-1
Sex:
female
Details on test animals and environmental conditions:
Alpk:CD-1 mouse (19-20 days old, 12-14g on receipt) supplied by Rodent Breeding Unit, Alderley Park, Macclesfield, Cheshire, U.K.

Administration / exposure

Route of administration:
subcutaneous
Vehicle:
arachis oil
Duration of treatment / exposure:
3 injections on 3 consecutive days
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0.5, 5.0, 50.0, 100.0 mg/kg bw.
No. of animals per sex per dose:
2
Details on study design:
Two female mice in each group were dosed once daily, by subcutaneous injection, for 3 consecutive days, with a dose volume of 5.0 ml/kg bw..

Examinations

Observations and examinations performed and frequency:
Clinical observations and bodyweight were recorded daily.
Sacrifice and pathology:
The animals were killed by an overdose of anaesthetic followed by exsanguination. No further examination.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
not examined
Histopathological findings: non-neoplastic:
not examined
Histopathological findings: neoplastic:
not examined
Details on results:
No effects on body weight and body weight gain (no control group)

Effect levels

Dose descriptor:
NOEL
Effect level:
>= 100 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
female
Basis for effect level:
other: Subcutaneous Doses up to and including 100.0 mg/ kg bw. dissolved in 5.0 ml/kg bw. arachis oil were tolerated without effects on body weight and without clinical signs.

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Subcutaneous Doses up to and including 100.0 mg/ kg bw. dissolved in 5.0 ml/kg bw. arachis oil were tolerated without effects on body weight and without clinical signs.

Applicant's summary and conclusion

Conclusions:
Subcutaneous Doses up to and including 100.0 mg/ kg bw. dissolved in 5.0 ml/kg bw. arachis oil were tolerated without effects on body weight and without clinical signs.
Executive summary:

Groups of 2 immature female Alpk:CD-1 mice (19-20 days old) received a single subcutaneous injection of 0.5, 5.0, 50,0, 100.0 mg/kg bodyweight of 4-HBA once a day for 3 consecutive days.

Subcutaneous Doses up to and including 100.0 mg/ kg bw. dissolved in 5.0 ml/kg bw. arachis oil were tolerated without effects on body weight and without clinical signs after administration to female immature CD-1 mice.