Soybean meal, protein extn. residue

Endpoint summary

Description of key information

Acute Oral Toxicity

Under the conditions of this study, the oral LD50 value in female Wistar rats was > 2 000 mg/kg body weight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 September 2017 to 18 October 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

RccHan™:WIST

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 8 to 12 weeks of age.
- Weight at study initiation: 155 to 180 g. The body weight variation did not exceed ± 20 % of the mean body weight at the start of treatment.
- Fasting period before study: An overnight fast immediately before dosing and for approximately 3 to 4 hours after dosing.
- Housing: The animals were housed in groups of up to four in suspended solid floor polypropylene cages furnished with wood flakes.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25 °C
- Humidity: 30 to 70 %
- Air changes: At least fifteen changes per hour.
- Photoperiod: Lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- For the purpose of the study the test material was freshly prepared, as required, as a suspension in distilled water.
- Formulation method: Vortex mixer for one minute.
- The test material was formulated within 2 hours of being applied to the test system. It is assumed that the formulation was stable for this duration. No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation.

DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD
- Rationale for the selection of the starting dose: Using available information on the toxicity of the test material, 2 000 mg/kg was chosen as the starting dose.

Doses:

2 000 mg/kg

No. of animals per sex per dose:

5 females

Control animals:

no

Details on study design:

- A single animal was treated at 2 000 mg/kg and in the absence of toxicity at that dose level, an additional group of 4 animals were also treated at 2 000 mg/kg. A total of five animals were therefore treated at a dose level of 2 000 mg/kg in the study.
All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each dose group to confirm the survival of the previously dosed animals.

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for up to 14 days. Morbidity and mortality checks were made twice daily, early and late during normal working days, and once daily at weekends and public holidays. Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: Yes. At the end of the observation period the surviving animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Statistics:

Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test material was made.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

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.

Interpretation of results:

other: Not classified in accordance with EU criteria.

Conclusions:

Under the conditions of this study, the oral LD50 value in female Wistar rats was > 2 000 mg/kg body weight.

Executive summary:

The acute oral toxicity of the test material was investigated in accordance with the standardised guidelines OECD 420 and EU Method B1 bis, under GLP conditions.

The study was performed to assess the acute oral toxicity of the test material in female Wistar strain rats. Following a sighting test at a dose level of 2 000 mg/kg, an additional four fasted female animals were given a single oral dose of test material, as a suspension in distilled water, at a dose level of 2 000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths and there were no signs of systemic toxicity. All animals showed expected gains in body weight and no abnormalities were noted at necropsy.

Under the conditions of this study, the oral LD50 value in female Wistar rats was established to exceed 2 000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute Oral Toxicity

The acute oral toxicity of the test material was investigated in accordance with the standardised guidelines OECD 420 and EU Method B1 bis, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

The study was performed to assess the acute oral toxicity of the test material in female Wistar strain rats. Following a sighting test at a dose level of 2 000 mg/kg, an additional four fasted female animals were given a single oral dose of test material, as a suspension in distilled water, at a dose level of 2 000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths and there were no signs of systemic toxicity. All animals showed expected gains in body weight and no abnormalities were noted at necropsy.

Under the conditions of this study, the oral LD50 value in female Wistar rats was established to exceed 2 000 mg/kg body weight.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to acute oral toxicity.