Registration Dossier
Registration Dossier
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EC number: 219-553-6 | CAS number: 2461-15-6
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:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
There is no available toxicity data concerning target substance on humans and no significant substance related incidences were reported, although the substance is widely used in industry.
A NOAEL (i.e. 100 mg/kg bw/day) for local effects in a repeated dose toxicity test is used to apply the diction “low hazard – no threshold derived” of local long-term exposure by dermal application as well as local acute exposure. At higher doses the skin barrier had been affected, although no systemic toxicity was seen. Thus, no DNELs for systemic long-term or acute toxicity were derived. As the existing data show the test substance is not an eye irritant, no hazard for eye effect is derived.
As the most likely route of worker exposure is considered to be via dermal exposure, a qualitative hazard assessment for local long-term and acute exposure is made but no hazard for the inhalation route is derived in lack of systemic toxicity.
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:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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
Based on the existing animal studies, it is indicated that the target substance is a skin irritant and a skin sensitizer, but non-irritating to eyes. Therefore, anyone that uses such chemical should avoid a direct contact to prevent irritation to human's skin, eyes and respiration system from test substance.
In addition, as the most likely route is considered to be via dermal, a qualitative assessment for medium hazards is to be made, but no threshold can be derived. However, as consumers only get exposed to formulations typically containing less than 5% by weight of the substance, risk is considered very low. Furthermore, no systemic hazards were seen in all available studies by oral or dermal route of exposure.
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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