Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Acute Toxicity: dermal
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- 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
Test material
- 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).
Constituent 1
Test animals
- 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
Administration / exposure
- 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
Results and discussion
Effect levels
- 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
Applicant's summary and conclusion
- 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.
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