Pidolic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 December 2016 - 17 January 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

2001

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

Pidolic acid

EC Number:

202-700-3

EC Name:

Pidolic acid

Cas Number:

98-79-3

Molecular formula:

C5H7NO3

IUPAC Name:

5-oxo-L-proline

Test material form:

solid: particulate/powder

Details on test material:

white solid crystalline powder

Specific details on test material used for the study:

Batch number: 20140124
Physical state/Appearance: white crystalline solid
Storage Conditions: room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Remarks:

RccHan™:WIST

Sex:

female

Details on test animals or test system and environmental conditions:

The females were nulliparous and non-pregnant. After an acclimatization period of at least 5 days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card. At the start of the study the animals were 8 to 12 weeks of age. With the exception of an overnight fast immediately before dosing and for approximately 3 to 4 hours after dosing, free access to mains drinking water and food. The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The volume administered to each animal was calculated according to the fasted body weight at the time of dosing.

Doses:

2000 mg/kg bw.

No. of animals per sex per dose:

Five.

Control animals:

no

Details on study design:

A single animal was treated with 2000 mg/kg bw dose. In the absence of toxicity at a dose level of 2000 mg/kg, an additional four animals were treated with the same dose.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systemic toxicity were noted during the observation period.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw.

Executive summary:

A study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat. Following a sighting test at a dose level of 2000 mg/kg bw, an additional four fasted female animals were given a single oral dose of the substance, as a solution in distilled water, at a dose level of 2000 mg/kg bw. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths. There were no signs of systemic toxicity. All animals showed expected gains in body weight. No abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw.