Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-074-6 | CAS number: 50-98-6
Endpoint summary
Administrative data
Description of key information
In several skin and eye irritation studies with the test substance or read-across substances only mild irritating effects were seen, which were fully reversible at the end of the observation period (8 days).
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:
In a dermal irritation study (BASF AG, 1981_80/198) six Vienna White Rabbits were dermally exposed to an aqueous solution (50 %) of the test item. The test site (intact dorsal skin) was covered with an occlusive dressing for 24 hours. Rabbits then were observed for 8 days. Irritations regarding erythema, edema and necrosis were scored by a method of Draize. Ephedrine-Hydrochloride exhibited a slightly irritating potential in this study (erythema score 0.7 -2.0, edema score 0 -1.7, all findings fully reversible within 8 days), without meeting the criteria for classifcation and labelling.
Three further skin irritation studies (BASF AG, 1986, 86/12 ; BASF AG, 1986, 86/11 ; BASF AG, 1986, 86/10) with the read-across substances DL-Ephedrin-HCl (CAS 134 -71 -4), (-)-Ephedrine-Sulfate (CAS 134 -72 -5) and (+)-Ephedrin-HCl (CAS 24221 -86 -1) are in line with this result and revealed no skin irritating properties.
Eye:
In an eye irritation study (BASF AG, 1981_80/198) six Vienna White Rabbits were exposed to 0.1 mL of the test item. Rabbits then were observed for 8 days. Findings were scored by a method of Draize. Ephedrine-Hydrochloride exhibited a slightly irritating potential in this study, but all findings were fully reversible within 8 days.
In three further eye irritation studies (BASF AG, 1986, 86/12 ; BASF AG, 1986, 86/11 ; BASF AG, 1986, 86/10) with the read-across substances DL-Ephedrin-HCl (CAS 134 -71 -4), (-)-Ephedrine-Sulfate (CAS 134 -72 -5) and (+)-Ephedrin-HCl (CAS 24221 -86 -1) also only mild irritation was observed.
Justification for selection of skin irritation / corrosion endpoint:
The key study was selected.
Justification for selection of eye irritation endpoint:
The key study was selected.
Justification for classification or non-classification
Based on the results of the eye and skin irritation studies, the test substance (-)-Ephedrin Hydrochlorid does not need to be classified according to Regulation (EC) No 1272/2008 or Directive 67/548/EC.
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.
