Registration Dossier
Registration Dossier
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EC number: 603-562-0 | CAS number: 13223-43-3
Endpoint summary
Administrative data
Description of key information
Oral:
An acute oral toxicity test (Up and Down Procedure) was conducted in accordance with EPA OPPTS 870.1100 (Acute Oral Toxicity) with F344 rats to determine the potential for ADTP to produce toxicity from a single dose via the oral route, Under the conditions of this study, the acute oral LD50 of the test substance was estimated to be 1,030 mg/kg of body weight in female rats with an approximate 95% confidence interval of 550 mg/kg (lower) to 1,750 mg/kg (upper).
Dermal:
An acute dermal toxicity test was conducted in accordance with EPA OPPTS 870.1200 (Acute Dermal Toxicity) with F344 rats to determine the potential for ADTP to produce toxicity from a single topical application. Under the conditions of this study, the single dose acute dermal LD50 of the test substance was greater than 5,000 mg/kg of body weight in male and female rats.
Acute inhalation toxicity has not been determined.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 1 030 mg/kg bw
Additional information
Oral:
The key study for acute oral toxicity was conducted in accordance with U.S. EPA. Health Effects Test Guidelines, OPPTS 870.1100 (2002). The study was conducted in line with GLP. A reliability rating of 1 according to the criteria of Klimisch, 1997.
The acute oral LD50 was found to be 1030 mg/kg
The key study for acute dermal toxicity was conducted in accordance with U.S. EPA. Health Effects Test Guidelines, OPPTS 870.1200 (Acute Dermal Toxicity). The study was conducted in line with GLP. A reliability rating of 1 according to the criteria of Klimisch, 1997. The acute dermal LD50 was found to be >5000 mg/kg.
Justification for classification or non-classification
Oral:
The acute oral LD50 of 1030 mg/kg falls within the range requiring classification under both DSD and CLP. According to Regulation EC No. 1272/2008 (CLP), the substance should be classified as Category 4 H302 (Harmful if swallowed) with the signal word "Warning". According to Directive 67/458/EEC (DSD), the substance should be classified as Xn with the risk phrase R22 (Harmful if swallowed).
Dermal:
The dermal LD50 of > 5000 mg/kg is greater than the cut off values specified in Regulation (EC) No. 1272/2008 and
Directive 67/548/EEC. Classification for acute dermal toxicity is therefore not required.
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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