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Toxicological information

Acute Toxicity: oral

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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

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:
- 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).