Registration Dossier
Registration Dossier
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EC number: 477-700-1 | CAS number: 883794-93-2
Endpoint summary
Administrative data
Description of key information
Oral (OECD 423), rat (female): LD50>2000 mg/kg bw
Inhalation: no data available
Dermal (OECD 402), rat (male/female): LD50>5000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate and reliable study (reliability 1). The information is sufficient for hazard assessment leading to an endpoint conclusion in accordance with Annex VIII, 1.2, of Regulation (EC) No 1907/2006. Therefore, the available information is sufficient to fulfil the standard information requirements set out in Annex VII, 8.5. of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate and reliable study (reliability 1). The information is sufficient for hazard assessment leading to an endpoint conclusion in accordance with Annex VIII, 1.2, of Regulation (EC) No 1907/2006. Therefore, the available information is sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5. of Regulation (EC) No 1907/2006.
Additional information
Acute toxicity: via oral route
A reliable key study is available, conducted according to OECD guideline 423 and in compliance with GLP. 6 female Sprague-Dawley rats in two steps were given the test item at a single dose of 2000 mg/kg bw. No mortality occurred throughout the study period and no clinical signs of toxicity were noted. Body weight development was as expected for this strain and age. Thus, the LD50 for the registered substance was set at >2000 mg/kg bw in female rats (Research Toxicology Centre, 2004).
Acute toxicity: via inhalation route
In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the inhalation route (required in Section 8.5. of REACH Annex VIII) does not need to be conducted as reliable data via the oral and dermal routes are available.
The commercial product is a granulated material. The substance is fixed in a matrix by embedding in polymer. The granulate size is approx. 1 cm in length and approx. 0.4 cm in diameter, therefore, exposure via the inhalation route is unlikely.
Acute toxicity: via dermal route
A reliable key study is available, conducted according to OECD guideline 402 and in compliance with GLP. 5 Sprague-Dawley rats per sex were administered the test item at a single dose of 5000 mg/kg bw (limit test) for 24 h under semi-occlusive conditions. Residual test item was washed off with water at the end of the exposure period. No mortality occurred throughout the study period and no clinical signs of toxicity were noted. The animals did not show any signs of dermal irritation throughout the study period. Body weight development was as expected for this strain and age. Thus, the LD50 for the registered substance was set at >5000 mg/kg bw in both male and female rats (Safety Evaluation Center Shenyang Res Inst Chemical Industry Ltd., 2014).
Justification for selection of acute toxicity – oral endpoint
The available key study was selected for assessment. The study was conducted according to OECD test guideline 423 and in compliance with GLP.
Justification for selection of acute toxicity – inhalation endpoint
In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the inhalation route (required in Section 8.5. of REACH Annex VIII) does not need to be conducted as reliable data via the oral and dermal routes are available.
Justification for selection of acute toxicity – dermal endpoint
The available key study was selected for assessment. The study was conducted according to OECD test guideline 402 and in compliance with GLP.
Justification for classification or non-classification
The available information on the registered substance is reliable and suitable for classification. The data do not meet the criteria for classification for acute toxicity according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC.
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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