Registration Dossier
Registration Dossier
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EC number: 417-040-3 | CAS number: -
Endpoint summary
Administrative data
Description of key information
This study was performed to assess the systemic toxicity of Coagulant 122 (solid) to the rat. The method followed was that outlined in Annex V, Part B, Method 87 in the EEC Directive92/69/EEC and OECD Guideline for Testing of Chemicals No. 407 'Repeated Dose Oral Toxicity - Rodent: 28-day or 14-day study'.
The study shows that there were no differences from control in parameters measured, namely mortality, clinical signs, bodyweight, food consumption, water consumption, haematology, biochemistry, macroscopic and microscopic pathology that were considered to be related to treatment.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Klimish: 1
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Coagulant l22(solid),a water treatment,was administered to groups of rats at dosages of 1000, 150 or 15 mg/kg/day for 29 consecutive days. A group of control rars received the vehicle, distilled water, alone.
There were no differences from control in any of the parameters investigated that were considered attributable to treatment with Coagulant 122 (solid).
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeted dose toxicity study via the inhalation route of exposure.
Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeted dose toxicity study via the inhalation route of exposure.
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeted dose toxicity study via the inhalation route of exposure.
Justification for selection of repeated dose toxicity dermal - local effects endpoint:
A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeted dose toxicity study via the inhalation route of exposure.
Justification for classification or non-classification
It was considered that 1000 mg/kg/day represents a no observed effect level (NOEL) for Coagulant 122 (solid) when administered for at least twenty-eight consecutive days to the rat. According to CLP Regulation (EC) 1272/2008, labelling with the H37348 hazardous phrase is not required for Coagulant 122 (solid).
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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