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EC number: 232-355-4 | CAS number: 8007-24-7 Extractives and their physically modified derivatives. Anacardium occidentale, Anacardiaceae.
Skin irritation/corrosion: Test method 16 CFR 1500.41. GLP study. The substance was determined to be a dermal irritant.
Eye irritation: Test method according to an in-house validated in-vitro Enucleated Eye Test. The substance was determined to be a severe eye irritant.
In a primary dermal irritation study, 3 young adult New Zealand white rabbits were dermally exposed to CNSL Distilled for 24 hours. Animals then were observed for 72 hours. Irritation was scored by the method of Draize. In this study, CNSL, Distilled is a dermal irritant.
Moderate loss of transparency was noted in all test eyes during the study.
Corneal swelling of the test eyes was considerably greater than that observed in the control eyes over the same period.
Pitting and sloughing of the corneal epithelium was noted in all test eyes during the study.
Moderate fluorescein uptake was noted in the test eyes 240 minutes following test material applicaiton. No fluorescein uptake was noted in the control eyes 240 minutes following treatment.
In a rabbit enucleated eye study 0.1 ml of CNSL, Distilled was instilled into three eyes of New Zealand White rabbits. The eyes were observed for 240 minutes. Irritation was scored by the method of McDonald-Shadduck.
Severe eye irritation was observed. In this study, CNSL, Distilled is a severe eye irritant.
Key study: A primary dermal irritation study was performed according to FHS Standard 16 CFR 1500.41 (GLP study). Three young adult New Zealand white rabbits were dermally exposed to test item for 24 hours. Animals were observed for 72 hours. Irritation was scored by the method of Draize. Two of the analysed samples were irritating to the skin (erythema and oedema scores > 2.3) and another two were determined to be not irritating to the skin. Based on these results, the substance was determined to a dermal irritant.
Key study: An in-house validated in-vitro Enucleated Eye Test study was performed to assess the potential to produce severe effects in eyes. 0.1 ml of test item was instilled into three eyes of New Zealand White rabbits. The eyes were observed for 240 minutes. Irritation was scored by the method of McDonald-Shadduck. Severe eye irritation was observed. The substance was determined to be a severe eye irritant.
Due to data sharing obligation and following ECHA’s indications, the registrant Wave S.L. has been forced to acquire robust study summaries for acute dermal, skin and eye irritation from CNSL Consortium. This consortium didn’t allow the registrant to get access to full study reports for quality evaluation and/or proper substance identification. Consequently the present REACH registration dossier contains the available information owned by CNSL Consortium.
Wave S.L. performed an acute oral toxicity study according to OECD Guideline 423 (GLP study) with its own substance. No mortalities were observed. The substance did not cause any clinical signs during the 14 days observation period. Body weight gains during the study showed no indication of a test item-related effect, and no macroscopic observations were seen at necropsy.
On the other hand, an acute dermal toxicity study was performed by CNSL Consortium according to OECD Guideline 402 (GLP study). No deaths occurred during the study and no systemic toxicity was observed. Nevertheless, changes in the body weight were noticed alongside with local effects. Thickening of the skin, haemorrhage of dermal capillaries, hardened light brown or dark brown/black coloured scab, small superficial scattered scabs, scab undulating, scab cracking and scab lifting at edges to reveal bleeding, dried blood, glossy skin or further deep scabbing were noted. Adverse reactions prevented accurate evaluation of erythema and oedema at all test sites during the study. Although no mortality was seen, the CNSL Consortium classified the substance as Acute Toxicity Category 4, H312, based in these local effects.
The effects observed in both acute toxicity studies are inconsistent. In the acute test performed by oral route no toxicity was observed, even at necropsy. Instead, dermal local effects were observed in rats exposed by dermal route. Therefore, it can be concluded that the test item from CNSL Consortium is toxicologically different from the one of Wave S.L.
Furthermore the studies performed by CNSL Consortium are not coherent among them as well. The local dermal effects seen in the acute dermal toxicity test are however not detected in the skin irritation test. Four different CNSL samples were tested for skin irritation according to FHSA standard 16 CFR 1500.41 (GLP study). Two of the analysed samples were irritating to the skin (mean 24-72h erythema and oedema scores > 2.3) and another two were determined to be not irritating. A difference on test sample composition is a very plausible explanation.
This registrant is not allowed to perform any of these studies in vertebrates without Authorities’ permission under risk to breaching Directive 2010/63/EU of The European Parliament and of The Council of 22nd of September 2010 regarding the protection of animals used for scientific purposes which prohibit duplicate testing. However under the light of acute oral toxicity test, no acute dermal effects can be anticipated for the substance object of the present REACH Registration dossier.
Justification for selection of skin irritation / corrosion endpoint:
Only one study available.
Justification for selection of eye irritation endpoint:
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: corrosive
Taking into account the available experimental data, the substance was determined to be classified for Skin Irritation Category 2, H315 (based on erythema and edema scores > 2.3) and for Severe Eye Damage Category 1, H318 (based on an in-vitro Enucleated Eye Test), in accordance with CLP Regulation (EU) no. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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