Registration Dossier
Registration Dossier
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EC number: 215-385-2 | CAS number: 1324-76-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Route of original study:
- Oral
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
As the most likely route is considered to be via oral, a DNEL for inhalation/dermal route is also unnecessary to be derived.
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no route to route extrapolation
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as a starting point.
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is based on dermal 28-day study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rats are used in the animal study.
- AF for other interspecies differences:
- 2.5
- Justification:
- No substance-specific data is available.
- AF for intraspecies differences:
- 10
- Justification:
- For general population, a default AF of 10 is to be used.
- AF for the quality of the whole database:
- 1
- Justification:
- A guideline test with GLP principle is used for assessment.
- AF for remaining uncertainties:
- 1
- Justification:
- No other uncertainties needed to be considered.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 mg/kg bw/day
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
There is no available toxicity data concerning testsubstance on human.
As the most likely route is considered to be via oral, a DNEL for inhalation/dermal route is also unnecessary to be derived. Detailed data of test article through oral route is available. A subacute study (NOTOX project 488231, 2008) following OECD Guideline 422 with GLP showed thatnotreatment-related toxicoiogically significant changes were noted in any of the parameters (i.e. mortality, clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, microscopic examination, reproduction, breeding and pup development) investigated in this study.Based upon the current animal data, NOAEL value of 1000mg/kg/day far exceed consumer exposure levels is used to derive the DNEL of test substance on oral toxicity for general population.
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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