Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Orthoboric acid, potassium salt as manufactured (45% w/w in highly refined base oil) was determined to not be irritating to skin in two studies performed in accordance with OECD 404 and EU Method B.4. Boric acid is used as read-across and is not irritating to skin or eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
Two studies investigating the skin irritation potential of the registered substance as manufactured are available. Both studies were conducted following a methodology equivalent to those outlined in standardised guidelines OECD 404 and EU Method B.4. During the studies, six male rabbits received four hour applications of 0.5 mL test material to two intact sites. All animals were assessed for the following 7 days for any signs of skin irritation. In Dougherty (1989a), no to slight erythema was observed one hour after exposure. Slight to well-defined erythema was observed at 24 hours and no to well-defined erythema was observed at 48 and 72 hours. No edema was observed at any time. All sites were free of irritation seven days after dosing. In Dougherty (1989b), slight to well-defined erythema with no to slight edema was observed one hour after exposure. No to well-defined erythema was observed at 24 hours. No to slight erythema was observed at 48 and 72 hours and all sites were free of irritation 7 days after dosing. The test material did not elicit any reaction in any of the animals during the course of either study that meant the test material required classification as a skin irritant.
Eye
An eye irritation study is not available for the registered substance. Boric acid is used as read across. The key study was performed according to FIFRA (40 CFR 158, 162); TSCA (40 CFR 7998). Minor effects on the iris and effects on the conjunctivae were reversed by Day 7. Not classifiable in the EU under directive 67/548/EEC.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Regulation 1272/2008 and Directive 67/548/EEC, the substance does not require classification for skin or eye irritation.
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.
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