4-hydroxybenzoic acid

Repeated dose toxicity: other routes

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

Test material information

Constituent 1

Reference substance name:

4-hydroxybenzoic acid

EC Number:

202-804-9

EC Name:

4-hydroxybenzoic acid

Cas Number:

99-96-7

Molecular formula:

C7H6O3

IUPAC Name:

4-hydroxybenzoic acid

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 or test system 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.