Registration Dossier
Registration Dossier
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EC number: 275-735-5 | CAS number: 71630-92-7 Substance obtained by burning the husk removed from the rice paddy. Contains silica as well as the elements aluminum, calcium, carbon, chromium, copper, indium, iron, lead, magnesium, manganese, molybdenum, phosphorus, silver, sodium, tin, and zinc.
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitising potential of rice husk ashes was tested in guinea pigs using a closed patch test according to Buehler, following OECD guideline 406 and conducted under GLP conditions. The test substance was prepared at 25% (w/w) in Vaseline and used at this concentration throughout the study. In the induction phase, 0.5 mL of the test substance preparation was applied onto the clipped skin of the left flank of 20 animals for 6 h using an occlusive dressing. The control group (10 animals) was treated similarly with the vehicle only. This procedure was repeated at weekly intervals for 3 weeks. Fourteen days after the last induction application, the test substance preparation was applied to the clipped skin of the right flank of all animals for 6 h. The left flank of all animals was treated simultaneously with vehicle only (intraspecific control). Skin reactions were evaluated 24 and 48 h after the challenge application. No signs of irritation were observed in any of the animals after the induction applications. After the challenge application, 4 out of 20 test animals and 3 out of 10 control animals showed scratches at the application site after treatment with the test item. 8 out of 20 test animals showed scratches at the application site after treatment with the vehicle. 1 out of 20 test animals showed scratches and eschar at the application site after treatment with the vehicle. No other treatment related effects were observed. The maximum percentage of animals sensitised was 0 %. Animals of both groups survived throughout the test period. No signs of toxicity were recorded (Ahuja, 2010).
Migrated from Short description of key information:
Rice husk ashes are not sensitising to the skin.
Justification for classification or non-classification
The available data on the skin sensitising potential of rice husk ashes is conclusive but not sufficient for classification according to DSD and CLP criteria for classification and labelling..
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