Registration Dossier
Registration Dossier
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EC number: 245-152-0 | CAS number: 22673-19-4
Endpoint summary
Administrative data
Description of key information
The following study was submitted to address the acute toxicity: oral endpoint:
Driscoll (1998). NEOSTANN U-220: ACUTE ORAL TOXICITY TEST IN THE RAT. Testing laboratory: Safepharm Laboratories Limited, P. O. Box No. 45, DERBY, DE1 2BT, UK. Report no.: 1194/001. Owner company: Nitto Kasei Co., Ltd., 17-14 Nishiawaji 3-chome, Higashiyodogawa-ku, Osaka, JAPAN. Report date: 1998-07-15.
The test material was reported to have an acute oral median lethal dose (LD50) and 95% confidence limits of 1864 (1039 - 3344) mg/kg bodyweight (Females only)
The following study was submitted to address the acute toxicity: dermal endpoint:
Sanders (2010). ACUTE DERMAL TOXICITY (LIMIT TEST) IN THE RAT. Testing laboratory: Harlan Laboratories.
Report no.: 3109/0061. Sponsor: Organo Tin REACH Consortium, c/o ReachCentrum, Avenue E. Van Nieuwenhuyse 6, B-1160, Brussels, BELGIUM.
The acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
A waiver has been submitted to address the acute toxicity: inhalation endpoint on the basis of lack of exposure.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 1 864 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Oral:
In the key study, Driscoll, 1998, conducted to OECD 401 and in compliance with GLP, the test material was found in rats to have an acute oral median lethal dose (LD50) and 95% confidence limits of 1864 (1039 - 3344) mg/kg bodyweight (Females only). The study was assigned a reliability score of 1 and considered suitable for assessment.
Dermal:
In the key study Sanders (2010), the acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight. The study was conducted to GLP and in line with a recognised guideline (OECD 402)
and has been allocated a Klimisch score of 1. The study is considered to be the key study for the acute dermal toxicity endpoint.
Inhalation:
A waiver has been submitted to address the acute toxicity: inhalation endpoint on the basis of lack of exposure
Justification for classification or non-classification
The substance has to be labelled with Xn; R22 Harmful if swallowed. Under GHS the substance is assigned to category 4 (Signal word: Warning; Hazard statement: H302 Harmful if swallowed).
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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