Lupine, L. albus, ext.

Endpoint summary

Description of key information

In an OECD guideline 423 study on rats, the LD50 of the test item IN 04 is higher than 2000 mg/kg body weight by oral route.

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:

2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

No data about test item composition

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Janvier (53940 Le genest St Isle FRANCE)
- Females nulliparous and non-pregnant
- Age at study initiation: about 7 weeks
- Weight at study initiation: 210.2g - 220.0g
- Housing: Animals were housed by group of three in solid bottomed clear polycarbonate cages with stain less steel mesh lid.
- Diet (e.g. ad libitum): Foodstuff (A04-10), ad libitum
- Water (e.g. ad libitum): Acidified, tap water (pH 2.5) (wtaer samples analyzed every 6 months for physico-chemical and bacteriological analysis)
- Acclimation period: 5 days at least

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22° C ± 2° C,
- Humidity (%): from 50 ± 20%,
- Air changes (per hr): at least 10 cycles per hour
- Photoperiod : (12 hrs day / 12 hrs darkness).

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

In the first step of the study, the test item was administrated by gavage under a volume of 2 mL/kg body weight (corresponding to 2000 mg/kg bw, according to study report).

Doses:

2 mL/ kg bw

No. of animals per sex per dose:

3 (females only)

Control animals:

no

Details on study design:

The animals were observed regularly on the day of administration (immediately, within 30 minutes after gavage, 1h, 2h, 3h and 4h after administration) and then at least once a day for at least 14 days.
Immediately after administration of the test item, attention was drawn to the signs of choking: in the event of death, the dead animals were immediately autopsied and it was verified that death was due to the toxicity of the test item and not to a track error.
The various parameters observed were: spontaneous activity, Preyer reflex, respiratory effect, convulsions, trembling, temperature, muscle tone, grip strength, palpebral ptosis, mydriasis, salivation, lacrimation, reversal reflex, piloerection, diarrhea, lethargy, Coma, changes in skin, coat, eyes, mucous membranes and mortality.

Animals were weighed on D-1 (day before the administration) and just before administering the test item, then on D4, D8 and D15 (equivalent to 3,7 an 14 days after the test item administration).

On D14, the animals were euthanized by intraperitoneal injection of sodium pentobarbital 6%, at a rate of 1.16 mL/ kg and bleeding at the femoral artery.
They were autopsied and the main organs were observed macroscopically.

Statistics:

None

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed

Clinical signs:

Slight piloerection was observed on treatment day.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was not classifÌed based on a LD50 higher than 2000 mg/kg bw and no significant toxic effects observed at that dose level.

Executive summary:

The test item IN 04 was administered to a group of 6 female Sprague Dawley rats at the dose of 2000 mg/kg body weight. The experimental protocol was established according to the official method as defined in the O.E.C.D. Test Guideline No. 423.

No mortality was noted in the animals treated at the dose of 2000 mg/kg body weight.

The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.

In conclusion, the LD50 of the test item IN 04 is higher than 2000 mg/kg body weight by oral route in the rat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

GLP study according to OECD 423 guideline

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

The test item IN 04 was administered to a group of 6 female Sprague Dawley rats at the dose of 2000 mg/kg body weight. The experimental protocol was established according to the official method as defined in the OECD Test Guideline No. 423.

No mortality was noted in the animals treated at the dose of 2000 mg/kg body weight.

The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.

In conclusion, the LD50 of the test item IN 04 is higher than 2000 mg/kg body weight by oral route in the rat.

Justification for classification or non-classification

In an OECD guideline 423 study performed on IN04 (mixture containing 18-25% Lupinus albus seed extract), the LD50 is higher than 2000 mg/kg body weight by oral route in the rat. In addition, the registered substance is mainly composed of proteins from Lupinus Albus, therefore no or very low acute toxicity, that should lead to classification of the substance for acute oral toxicity is anticipated.Thus no classification is required for the registered substance according to CLP Regulation (1272/2008(CE)).