Registration Dossier
Registration Dossier
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EC number: 700-155-0 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
DNEL related information
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Workers - Hazard for the eyes
Additional information - workers
The Derived No-Effect Levels (DNEL) were calculated using the recommendations of the ECHA "Guidance on information requirements and chemical safety assessment – Chapter R.8: Characterisation of dose [concentration]-response for human health" (December 2010).
The adverse effects selected for DNEL derivation were considered to bear a threshold mode of action.
- Acute toxicity:
In the absence of any relevant toxic effect and in particular any acute toxicity hazard leading to Classification & Labelling, no specific DNEL was derived.
- Irritation/Corrosion:
In the absence of irritation effects related to the test substance, no specific DNEL was derived.
- Sensitization:
In the absence of skin sensitization effects related to the test substance, no specific DNEL was derived.
- Repeat-dose toxicity:
Dermal exposure:
The study selected for dermal DNEL derivation is the OECD 422-compliant study in rats (Hameln, 2011) where a NOAEL was determined at 300 mg/kg bw/d in females based on fertility effects observed. The NOAEL in males is the highest dose tested (1000 mg/kg bw/d).
- Dose descriptor: NOAEL = 300 mg/kg bw in female rats
- Corrected dose descriptor: No correction was applied (dermal NOAEL = oral NOAEL because both oral and dermal absorptions are considered to be low)
- Assessment factors:
Interspecies differences = 4 (default value for rats)
Other toxicokinetic differences = 2.5 (default value for rats)
Intraspecies differences = 5 (default value for workers)
Differences in exposure duration = 6 (default value for subacute to chronic exposure extrapolation)
Dose-response issues = 1 (use of a NOAEL as a starting point)
Quality of the database = 1 (complete and reliable data)
=> Global assessment factor = 300
- DNEL calculation:
Worker-DNEL long-term for dermal route, systemic effects = 300 / 300 = 1 mg/kg bw
Inhalation exposure:
Exposure of humans via inhalation is unlikely; handling of the registered substance does not produce vapour, aerosols or droplets. Furthermore, the most probable route of exposure is the dermal route since the substance is produced and commercialized as a liquid.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
The Derived No-Effect Levels (DNEL) were calculated using the recommendations of the ECHA "Guidance on information requirements and chemical safety assessment – Chapter R.8: Characterisation of dose [concentration]-response for human health" (December 2010).
The adverse effects selected for DNEL derivation were considered to bear a threshold mode of action.
- Acute toxicity:
In the absence of any relevant toxic effect and in particular any acute toxicity hazard leading to Classification & Labelling, no specific DNEL was derived.
- Irritation/Corrosion:
In the absence of irritation effects related to the test substance, no specific DNEL was derived.
- Sensitization:
In the absence of skin sensitization effects related to the test substance, no specific DNEL was derived.
- Repeat-dose toxicity:
Dermal / Oral exposure:
The study selected for dermal DNEL derivation is the OECD 422-compliant study in rats (Hameln, 2011) where a NOAEL was determined at 300 mg/kg bw/d in females based on fertility effects observed. The NOAEL in males is the highest dose tested (1000 mg/kg bw/d).
- Dose descriptor: NOAEL = 300 mg/kg bw in female rats
- Corrected dose descriptor: No correction was applied (dermal NOAEL = oral NOAEL because both oral and dermal absorptions are considered to be low)
- Assessment factors:
Interspecies differences = 4 (default value for rats)
Other toxicokinetic differences = 2.5 (default value for rats)
Intraspecies differences = 10 (default value for consumers)
Differences in exposure duration = 6 (default value for subacute to chronic exposure extrapolation)
Dose-response issues = 1 (use of a NOAEL as a starting point)
Quality of the database = 1 (complete and reliable data)
=> Global assessment factor = 600
- DNEL calculation:
Consumer-DNEL long-term for dermal / oral route, systemic effects = 300 / 600 = 0.5 mg/kg bw
Inhalation exposure:
Exposure of humans via inhalation is unlikely; handling of the registered substance does not produce vapour, aerosols or droplets. Furthermore, the most probable route of exposure is the dermal route since the substance is produced and commercialized as a liquid.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
