Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled, oligomerisation products with 1-chloro-2,3-epoxypropane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled, oligomerisation products with 1-chloro-2,3-epoxypropane

Cas Number:

68413-24-1

Molecular formula:

C24H36O2

IUPAC Name:

Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled, oligomerisation products with 1-chloro-2,3-epoxypropane

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): CARDOLITE NC-513
- Lot/batch No.: GH-0129
- Expiration date of the lot/batch: 13.07.2014
- Storage condition of test material: room temperature
- Other: the test item was previously considered as 'Cashew, nutshell liq., oligomeric reaction products with 1-chloro-2,3-epoxypropane' (EC number 500-210-7).

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories France, Boîte postale 0109, 69592 L’ARBRESLE , France
- Age at study initiation: 8 and 12 weeks
- Weight at study initiation: 150 and 250 g
- Fasting period before study: yes (approx. 12h)
- Housing: transparent polycarbonate (macrolone type III) cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 50 % ± 20 %
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 1000 mg per mL

MAXIMUM DOSE VOLUME APPLIED: 2 mL per kg of body weight per animal

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no toxicity expected

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily/ 3 times per week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: Behaviour, impact on RS or CNS

Body weight:

other body weight observations

Remarks:

The body weight gain per day was calculated for each animal, as well as the average of the body weight gain per day for each study group. Averages of body weight gain per day are: for group 1 (2000 mg/kg CARDOLITE NC-513): 3.2 g/day for group 2 (2000 mg/kg CARDOLITE NC-513): 0.6 g/day The comparison to published results in literature as well as to the results obtained in other studies performed by the laboratory revealed that growth of all animals of the study group 1 is in the same range than growth of normally untreated SD (Sprague Dawley) rats, in contrary of the growth of the animals for the group 2. Weight gain for the group 1 is about five times higher than in group 2. Furthermore, a weight loss peak was recorded for each group approximately at the same time: from day 8 to day 11 for both groups. Nevertheless, this weight loss is more remarkable in group 2 than in group 1

Gross pathology:

No abnormalities were recorded during the macroscopic examination.

Other findings:

Oral gavage at dose level of 2000 mg per kg body weight of the test item, CARDOLITE NC-513, may influence the food consumption and may have an impact on the appetite.

Applicant's summary and conclusion

Interpretation of results:

other:

Remarks:

EU GHS criteria not met

Conclusions:

In a GLP-study according to OECD Test Guideline 423, the acute oral LD50 of the registered substance was determined to be > 2000 mg/kg bw.

Executive summary:

The results obtained in a GLP-study according to OECD Test Guideline 423 indicate that a single administration of CARDOLITE NC-513 at 2000 mg/kg on female rats did not result in behavior changes. No clinical signs were detected during the study.

However CARDOLITE NC-513 had an influence on food consumption and on weight gain especially in group 2.

Due to the low number of animals no statistical analysis was performed.

In consequence no statistical difference could be highlighted.

Some differences were observed between both groups despite the fact that both groups were injected with the same dose of CARDOLITE NC-513 (2000 mg/kg) using the same conditions of injection,

In conclusion oral gavage at dose level of 2000 mg per kg body weightof the test item, CARDOLITE NC-513, may influence the food consumption and may have an impact on the appetite, but has no lethal effect on animals.

The LD₅₀ cut off of the test item CARDOLITE NC-513 is higher than 2000 mg/kg body weight.