Registration Dossier
Registration Dossier
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EC number: 414-420-0 | CAS number: - SPE 93279
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10.6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 264.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Step 1) Relevant dose-descriptor: NOAEL, rat = 150 mg/kg bw per day
Step 2) Modification of starting point
- Conversion into inhalation NOAEC (in mg/m³) by using an 8-hour respiratory volume for the rat: 0.38 m³/kg bw
- Correction for activity driven differences of respiratory volumes in workers compared to workers in rest: 6.7 m³/10 m³
- Correction for inhalation to oral absorption: no factor is added. Justification: the test substance has a low volatility (vapour pressure of less than 0.00005 Pa).
- No difference in oral and inhalation absorption is expected between rats and human. NOAEC corrected = (150 x 1 / 0.38) x (6.7 / 10) = 264.5 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Exposure duration: subchronic (90 days) to chronic = 2
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
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:
- DNEL (Derived No Effect Level)
- Value:
- 1.5 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Step 1) Relevant dose-descriptor: NOAEL, rat = 150 mg/kg bw per day
Step 2) Modification of starting point
Correcting for dermal to oral absorption: factor of 1 is used. The value of Log Kow is moderately low (1.1), suggesting that this value will favour dermal penetration from the stratum corneum into the epidermis. Its known surfactant properties may also exert an unknown influence on its uptake and adsorption. Furthermore, the test substance is very soluble in water (> 10000 mg/l). As no dermal penetration study is available, 100% absorption will be considered as a worst case. No difference in oral and dermal absorption is expected between rats and human.
Corrected dermal NOAEL: 150 mg/kg-day x 100%/100% = 150 mg/kg-day.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic (90 days) to chronic = 2
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
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:
- low hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 130.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Step 1) Relevant dose-descriptor: NOAEL, rat = 150 mg/kg bw per day
Step 2) Modification of starting point
- Conversion into inhalation NOAEC (in mg/m³) by using an 24-hour respiratory volume for the rat: 1.15 m³/kg bw
- Correction for inhalation to oral absorption: no factor is added. Justification: the test substance has a low volatility (boiling point above 150°C, vapour pressure of less than 0.00005 Pa).
- No difference in oral and inhalation absorption is expected between rats and human.
NOAEC corrected = 150 x 1 / 1.15 = 130.4 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic (90 days) to chronic = 2
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.75 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):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Step 1) Relevant dose-descriptor: NOAEL, rat = 150 mg/kg bw per day
Step 2) Modification of starting point
Correction for absorption difference between rat and human, and between dermal and oral absorption: no difference in dermal and oral absorption is expected between rats and humans. A default oral and dermal absorption of 100% in rats and humans is used for DNEL derivation.
Corrected dermal NOAEL: 150 mg/kg-day x 100%/100% = 150 mg/kg-day.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic (90 days) to chronic = 2
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- Justification:
- genera population
- AF for the quality of the whole database:
- 1
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.75 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):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No need to extrapolate since the key study was performed by oral route
- AF for dose response relationship:
- 1
- Justification:
- NOAEL
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
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