Propyl 4-hydroxybenzoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions. Necropsy was not performed in all surviving animals. Not performed according to GLP. No analytical purity was given in the study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Propyl 4-hydroxybenzoate

EC Number:

202-307-7

EC Name:

Propyl 4-hydroxybenzoate

Cas Number:

94-13-3

Molecular formula:

C10H12O3

IUPAC Name:

propyl 4-hydroxybenzoate

Details on test material:

- Name of test material (as cited in study report): Solbrol P
- Physical state: solid
- Analytical purity: no data

Test animals

Species:

rat

Strain:

other: Wistar (BOR:WISW)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 9 - 14 weeks
- Weight at study initiation: 182 g (males), 175 g (females)
- Fasting period before study: Animals were fasted from 16 h before application until 4 h after application. During this period tap water was available.
- Housing: Groups of five animals were housed in Makrolon cages type III with dustfree wood pellets as bedding material.
- Diet: Altromin R 1324, Altromin GmbH, Germany, ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1.5
- Humidity (%): 60 ± 5
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 23 Nov 1981
To: 7 Dec 1981

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Lutrol

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Animals were periodically observed for clinical signs on the treatment day and twice daily thereafter until the end of the observation period. Body weights were recorded right before application and weekly thereafter.
- Necropsy of survivors performed: yes, on a random basis
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred until the end of observation period.

Clinical signs:

other: No clinical signs were observed until the end of the study period.

Gross pathology:

Necropsy on a random basis revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 is >5000 mg/kg bw for male and female rats

Executive summary:

An acute oral toxicity study on propylparaben was performed similar to OECD 401 (Loeser, 1982). A single propylparaben dose of 5000 mg/kg bw was applied by gavage to groups of 5 male and 5 female rats. During the observation period of 14 days after application, no mortality occurred and no clinical signs were noticed. Necropsy of animals chosen on a random basis revealed no test substance related findings.Therefore, the LD50 is >5000 mg/kg bw for male and female rats.