Registration Dossier
Registration Dossier
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EC number: 916-331-7 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
As no classification and labelling is necessary for acute systemic effects, no acute DNEL is derived, in accordance with ECHA guidance R.8 (2012): Characterisation of dose [concentration]-response for human health. Furthermore, no DNELs for local effects have been derived, as no acute or long-term local effects were observed. In accordance with ECHA Practical Guide 14 (How to prepare toxicological summaries in IUCLID and how to derive DNELs, 2012) no DNELs for systemic effects were derived based on the absence of effects up to the limit dose in the oral 90-day study of structural similar substance Cyclacet, in which a NOAEL of >=1500 mg/kg bw/day was established (highest dose tested). This is supported by the reproscreening study also with Cyclacet, in which a NOAEL of >=1000 mg/kg bw/day was found. Also Cyclobutanate also showed a NOAEL >=1000 mg/kg bw in a 28 -day repeated dose toxicity study.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
As no classification and labelling is necessary for acute effects, no acute DNEL is derived, in accordance with the Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health (2012). Furthermore, no DNELs for local effects have been derived, as no local effects were observed. In accordance with ECHA Practical Guide 14 (How to prepare toxicological summaries in IUCLID and how to derive DNELs), no DNELs for systemic effects were derived based on the absence of effects in the oral 90-day study of structural similar substance Cyclacet, in which a NOAEL of >=1500 mg/kg bw/day was established, supported by the reproscreening study with the same substance, in which a NOAEL of >=1000 mg/kg bw/day was also found. Also in a 28 -day repeated dose toxicity study with Cyclobutanate, which contains a butanoic instead of a isobutanoic ester a NOAEL of >= 1000 mg/kg bw was found.
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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