Sodium 4-propoxycarbonylphenoxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Apr - June 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well reported study, performance equivalent to OECD Guideline 401 with some minor restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Remarks:

Necropsy was not performed in all surviving animals

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 4-propoxycarbonylphenoxide

EC Number:

252-488-1

EC Name:

Sodium 4-propoxycarbonylphenoxide

Cas Number:

35285-69-9

Molecular formula:

C10H12O3.Na

IUPAC Name:

propyl 4-hydroxybenzoate

Test material form:

other: solid

Test animals

Species:

rat

Strain:

Wistar

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: 176 g (males), 176 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:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

1000, 3100 or 5000 mg/kg bw (females)
3100 or 5000 mg/kg bw (males)

No. of animals per sex per dose:

10

Control animals:

no

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

Remarks on result:

other: 7/20 animals died at 5000 mg/kg bw (5 females and 2 males)

Mortality:

No mortality occurred in the 1000 mg/kg bw group. In the 3100 mg/kg bw group, 1/10 females died during the first day after application of the test substance. In the 5000 mg/kg bw group, 2/10 males and 5/10 females were found dead during the first 3 days after application of the test substance.

Clinical signs:

other: Clinical signs were observed at 3100 mg/kg bw (females) and higher or at 5000 mg/kg bw (males). The general condition of all animals was decreased. They showed signs of sedation and anaesthesia. These symptoms were (almost) fully reversible within 7 days

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:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

The median lethal dose of the test substance (LD50) was greater than 5000 mg per kg body weight. Based on the result of this study the substance is not subject for labelling and classification requirements according to regulatory requirements.

Executive summary:

The potential acute oral toxicity of sodium 4-propoxycarbonylphenoxide (CAS 35285-69-9) was assessed in a study performed according to a protocol similar to OECD 401 (Bayer, 1982). 10 rats/sex were administered 1000 (only in females), 3100 and 5000 mg/kg bw of the test substance by gavage. No mortality occurred in the 1000 mg/kg bw group. In the 3100 mg/kg bw group, 1/10 females died during the first day after application of the test substance. In the 5000 mg/kg bw group, 2/10 males and 5/10 females were found dead during the first 3 days after application of the test substance. Clinical signs were observed at 3100 mg/kg bw (females) and higher or at 5000 mg/kg bw (males). The general condition of all animals was decreased. Signs of sedation and anaesthesia were observed. These symptoms were (almost) fully reversible within 7 days (females) or 2 days (males). Necropsy in surviving animals on random basis revealed no substance related findings. Based on the results of the conducted study, the oral LD50 value is considered to be > 5000 mg/kg bw .