Acacia mearnsi, ext., reaction products with ammonium chloride and formaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 14 july 2006 to 08 August 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the OECD internationally recognised guideline and according to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acquapol C1

IUPAC Name:

Acquapol C1

Test material form:

other: Liquid

Details on test material:

- Name of test material: Acacia mearnsi extract
- Purity: 100%
- Substance type: UVCB
- Other: aqueous solution of quaternary ammonium tannate
- Physical state: liquide

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: between 8 and 12 weeks
- Weight at study initiation: between 171 and 229g
- Fasting period before study: 12 hours
- Housing: polypropylene boxes covered by metal grid and lined with wooden shavings, with a maximum number of 5 animals per box
- Diet (e.g. ad libitum): commercial feed ad libitum
- Water (e.g. ad libitum): filtered water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

- 1000 mg/mL, dose of 2000 mg/kg

Doses:

- Pre-test : 2000 mg/kg of live weight
- Final test : 2000 mg/kg of live weight

No. of animals per sex per dose:

- Pre-test : one animal (female) per doses
- Final test : 5 animals (female) per doses

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: at the beginning and at the end of the study
- Necropsy of survivors performed: yes (heart, lung, liver, stomach, intestines, kidneys, adrenal glands and spleen)
- Other examinations performed: clinical signs (skin, hair, eyes, mucosae, circulatory, respiratory, nervous systems, somatomotor) and behavioral activity

Results and discussion

Preliminary study:

- Pre-test, one female rat oraly exposed at the dose of 2000 mg/kg of live weight: no death, the animal did not show clinical signs of toxicity

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Number of deaths: 0

Clinical signs:

other: - The animals did not show clinical signs of toxicity

Other findings:

- Other observations: respiratory system, cadiovasculatory system, digestive system, genitourinary system: not noteworthy up to the dose of 2000 mg/kg of live weight

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

- By oral route in the condition of the test, the substance is not toxic. According to the criteria given in Annex I of Regulation EC/1272/2008, the substance Acacia mearnsi extract should not be classified as hazadous for acute oral toxicity.

Executive summary:

The Acute Oral Toxicity Test-Fixed Dose for rats was conducted to study the potential toxic effects of ACQUAPOL C1. The product was used in pure form (liquid) and administrated orally to rats that were 8 - 12 weeks old, at the dose of 2000 mg/kg of live weight in the pre-test, and at the dose of 2000 mg/kg of live weight for the final test. The animals were observed for time to death, behavioral changes, clinical signs and macroscopic anatomopathological findings. The final test was conducted with a dose of 2000 mg/kg of live weight, in which the animals do not present clinical signs of toxicity, which allows the product ACQUAPOL C1 to be classified in toxicological class V (Non-toxic) according to the classification table for acute toxicological risk according to GHS-OECD by oral route. Moreover, according to the criteria given in Annex I of Regulation EC/1272/2008, the substance Acacia mearnsi extract should not be classified as hazadous for acute oral toxicity in the testing conditions (LD50 > 2000 mg/kg of live weight).