Ethyl 4-hydroxybenzoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3.8. - 6.9.1982

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:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Necropsy was not performed in all surviving animals; no data on analytical purity was given.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl 4-hydroxybenzoate

EC Number:

204-399-4

EC Name:

Ethyl 4-hydroxybenzoate

Cas Number:

120-47-8

Molecular formula:

C9H10O3

IUPAC Name:

ethyl 4-hydroxybenzoate

Details on test material:

- Name of test material (as cited in study report): Solbrol A
- 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: 162 g (males), 170 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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Lutrol

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

1000, 3100 and 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

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 100 mg/kg bw

Based on:

test mat.

Remarks on result:

other: based on the death of 4/10 animals each in the 3100 and 5000 mg/kg bw group

Mortality:

No mortality occurred in the 1000 mg/kg bw group. In the 3100 mg/kg bw group, 1/5 males and 3/5 females died during the first 8 h after application of the test substance. In the 5000 mg/kg bw group, 1/5 males and 3/5 females were found dead during the first hour after application of the test substance.

Clinical signs:

other: No clinical signs were observed in the 1000 mg/kg bw group. In the 3100 and 5000 mg/kg bw groups, the general condition of all animals was decreased and they layed down in side or prone position and showed signs of sedation and anaesthesia. These symptoms

Gross pathology:

Necropsy of surviving animals on a radom basis revealed no substance-related findings. No necropsy or histopahological examination was done in the animals that died during the observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified