Registration Dossier
Registration Dossier
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EC number: 216-643-7 | CAS number: 1633-05-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 12.4 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 125 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The starting point is the NOAEL of 22.5 mg/kg/day determined in the 90-day toxicity study performed in rats with Strontium chloride hexahydrate. It corresponds to 12.4 mg SrCO3/kg/day.
Route to route extrapolation - from oral to inhalation:
NOAEC worker (8h) = oral NOAEL * (70 kg / 10 m3) * (ABS oral-rat / ABS inh-human) = 12.4*(70/10)*(20/13.9) = 125 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- The point of departure is a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- The point of departure was determined in a subchronic toxicity study (90-days).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- The point of departure was determined in a rat study. However, any metabolism of inorganic strontium substances can be excluded. Therefore, it is considered justified to deviate from default assessment factors accounting for a correction for differences in metabolic rate by assigning a factor of “1” instead of using the default factor of 4.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA R8 guidance default assessment factor for systemic effects.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA R8 guidance default assessment factor for worker population.
- AF for the quality of the whole database:
- 1
- Justification:
- The point of departure was determined in well-documented study. Although the study was not performed under GLP requirements, it fulfills the requirements of the current test guideline for oral sub-chronic exposure to a great extent.
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:
- 9.92 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 12.4 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 248 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The starting point is the NOAEL of 22.5 mg/kg/day determined in the 90-day toxicity study performed in rats with Strontium chloride hexahydrate. It corresponds to 12.4 mg SrCO3/kg/day.
Route to route extrapolation - from oral to dermal :
NOAELworker = oral NOAEL * ABSoral-rat / ABSdermal-human = 12.4 * 20 / 1 = 248 mg/kg/day
- AF for dose response relationship:
- 1
- Justification:
- The point of departure is a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- The point of departure was determined in a subchronic toxicity study (90-days).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- The point of departure was determined in a rat study. However, any metabolism of inorganic strontium substances can be excluded. Therefore, it is considered justified to deviate from default assessment factors accounting for a correction for differences in metabolic rate by assigning a factor of “1” instead of using the default factor of 4.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA R8 guidance default assessment factor for systemic effects.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA R8 guidance default assessment factor for worker population.
- AF for the quality of the whole database:
- 1
- Justification:
- The point of departure was determined in well-documented study. Although the study was not performed under GLP requirements, it fulfills the requirements of the current test guideline for oral sub-chronic exposure to a great extent.
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
For information on derivation of DNELs please refer to the CSR.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 12.4 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 62.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The starting point is the NOAEL of 22.5 mg/kg/day determined in the 90-day toxicity study performed in rats with Strontium chloride hexahydrate. It corresponds to 12.4 mg SrCO3/kg/day.
Route to route extrapolation - from oral to inhalation:
NOAEC worker (8h) = oral NOAEL * (70 kg / 20 m3) * (ABS oral-rat / ABS inh-human) = 12.4*(70/20)*(20/13.9) = 62.4 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- The point of departure is a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- The point of departure was determined in a subchronic toxicity study (90-days).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- The point of departure was determined in a rat study. However, any metabolism of inorganic strontium substances can be excluded. Therefore, it is considered justified to deviate from default assessment factors accounting for a correction for differences in metabolic rate by assigning a factor of “1” instead of using the default factor of 4.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA R8 guidance default assessment factor for systemic effects.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA R8 guidance default assessment factor for general population.
- AF for the quality of the whole database:
- 1
- Justification:
- The point of departure was determined in well-documented study. Although the study was not performed under GLP requirements, it fulfills the requirements of the current test guideline for oral sub-chronic exposure to a great extent.
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 12.4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The starting point is the NOAEL of 22.5 mg/kg/day determined in the 90-day toxicity study performed in rats with Strontium chloride hexahydrate. It corresponds to 12.4 mg SrCO3/kg/day.
- AF for dose response relationship:
- 1
- Justification:
- The point of departure is a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- The point of departure was determined in a subchronic toxicity study (90-days).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- The point of departure was determined in a rat study. However, any metabolism of inorganic strontium substances can be excluded. Therefore, it is considered justified to deviate from default assessment factors accounting for a correction for differences in metabolic rate by assigning a factor of “1” instead of using the default factor of 4.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA R8 guidance default assessment factor for systemic effects.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA R8 guidance default assessment factor for general population.
- AF for the quality of the whole database:
- 1
- Justification:
- The point of departure was determined in well-documented study. Although the study was not performed under GLP requirements, it fulfills the requirements of the current test guideline for oral sub-chronic exposure to a great extent.
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
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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