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

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

some minor deviations (no impact)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/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: no information
- Weight at study initiation: 200 - 300 g
- Fasting period before study: no
- 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

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: One day after the application coordination was impacted during a period of one day. Skin from almost all animals was affected: desquamation, small wounds, and skin irritation

Body weight:

other body weight observations

Remarks:

reduced female body weight gain due to reduced food consumption

Interpretation of results:

other: EU GHS criteria not met

Conclusions:

In a GLP-study according to OECD Test Guideline 402 conducted as a limit test, the acute dermal LD50 of the registered substance was determined to be > 2000 mg/kg bw.

Executive summary:

The results of a limit test according to OECD Test Guideline 402 indicate that a single dermal application of CARDOLITE NC-513 at 2000 mg/kg on female and male rats did not result in major behavior changes. One day after the application coordination was impacted during a period of one day but no other clinical signs were detected during the study. Some reversible effects on skin such as desquamation, small wounds, and skin irritation were observed. Kidney abnormalities (such as hemorrhagic stain) for male and female were recorded during the macroscopic examination after necropsy. CARDOLITE NC-513 had an influence on food consumption and on weight gain for

female In conclusion dermal application 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 for female.

In conclusion the LD₅₀ of the test item CARDOLITE NC-513 is higher than 2000 mg/kg body weight by dermal route in the rat.

Results and discussion

Clinical signs:

other: