Registration Dossier
Registration Dossier
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EC number: 231-511-9 | CAS number: 7601-89-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.28 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):
- 5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- 0,2 mg/kg/day x (70 kg /10 m3) - No correction for inhalatory and oral absorption rates. The vapour pressure is small (0.00287 Pa at 20°C), therefore MOTE has a low volatility
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- NOAEL from human study
- AF for other interspecies differences:
- 1
- Justification:
- NOAEL from human study
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality of the whole database
- AF for remaining uncertainties:
- 1
- Justification:
- NOAEL from human study
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.16 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):
- 5
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10.8
- Explanation for the modification of the dose descriptor starting point:
- NOAEL corrected = 0.20 x 100 / 1.85 = 10.8 mg/kg bw;: A dermal absorption is 1.85% (study on chlorate) and the oral absorption is estimated to 100%.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- Chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- NOAEL from human study
- AF for other interspecies differences:
- 1
- Justification:
- NOAEL from human study
- AF for intraspecies differences:
- 5
- Justification:
- workers safety factors by default
- AF for the quality of the whole database:
- 1
- Justification:
- comprehensive database
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
WORKERS
1. Acute / short term exposure - systemic effects
Dermal route : Based on the available data, the substance is not classified for this endpoint (LD50>2000 mg/kg).
Inhalation route : Due to the lack of information for the inhalation route, no DNEL is derived.
2. Acute / short term exposure - local effects
No information on local effects (dermal and inhalation routes) are available.
3. Long-term exposure - systemic effects
3.1 Dermal DNEL
In the cross sectional study of Bravermann (2005), 29 male workers exposed chronically to perchlorate, mainly by respiratory route, were investigated for perchlorate exposure level (based on serum and urine perchlorate concentrations) and a whole range of thyroid and hematological and biochemical endpoints. When comparing with normal limits, it could be concluded that no effect on T3, T4 and TSH, thyroid volume, thyroglobulin and urinary iodine excretion occurred at a median absorbed dose of 0.167 mg perchlorate ion/kg/day, over 5.9 years (median: chronic exposure) for 42h/week. Free T4 index was above normal limits in all groups but this is the opposite to the expected effect of perchlorate. Exposure of exposed workers was demonstrated by decreased radioiodine uptake and the detectable serum and urinary perchlorate levels (non-adverse effects).In workers, the equivalent AP exposure level, calculated as 0.20 mg AP/kg/day, was a NOAEL.
Step 1) Relevant dose-descriptor:NOAEL, human = 0.20 mg/kg bw/d
Step 2) Modification of starting point:
* Correction for absorption difference between dermal and oral absorption in human:A dermal absorption is 1.85% (study on chlorate) and the oral absorption is estimated to 100%.
NOAEL corrected = 0.20 x 100 / 1.85 = 10.8 mg/kg bw
Step 3) Assessment factors:
* Interspecies: no factor (human)
* Intraspecies: 5(workers)
* Exposure duration: 1 (chronic study)
* Dose response: 1(NOAEL)
* Quality of database: 1
AF total = 5x1x1x1 = 5
Step 4) DNEL derivation:
DNEL value = 10.8 / 5 = 2.16 mg/kg bw
DNEL Long-term – Dermal value based on human study is 2.16 mg/kg bw.
3.2 Inhalation DNEL
In the cross sectional study of Bravermann (2005), 29 male workers exposed chronically to perchlorate, mainly by respiratory route, were investigated for perchlorate exposure level (based on serum and urine perchlorate concentrations) and a whole range of thyroid and hematological and biochemical endpoints. When comparing with normal limits, it could be concluded that no effect on T3, T4 and TSH, thyroid volume, thyroglobulin and urinary iodine excretion occurred at a median absorbed dose of 0.167 mg perchlorate ion/kg/day, over 5.9 years (median: chronic exposure) for 42h/week. Free T4 index was above normal limits in all groups but this is the opposite to the expected effect of perchlorate. Exposure of exposed workers was demonstrated by decreased radioiodine uptake and the detectable serum and urinary perchlorate levels (non-adverse effects).In workers, the equivalent AP exposure level, calculated as 0.20 mg AP/kg/day, was a NOAEL.
Step 1) Relevant dose-descriptor:NOAEL, human = 0.20 mg/kg bw/d
Step 2) Modification of starting point:
Correction of respiratory volume for relevant duration:The respiratory volume light activity for worker (8h exposure) is 10 m3/person. And the weight of a human is 70 kg per default.
* Correction for absorption difference between oral and inhalation in human:A default oral and inhalation absorption of 100% in humans are used for DNEL derivation.
NOAEC corrected = 0.20 x 70 / 10 = 1.4 mg/m3
Step 3) Assessment factors:
* Interspecies : no factor (human)
* Intraspecies : 5(workers)
* Exposure duration: 1 (chronic study)
* Dose response : 1(NOAEL)
* Quality of database : 1
AF total = 5 x1x 1x1= 5
Step 4) DNEL derivation:
DNEL value = 1.4 / 5 = 0.28 mg/m3
DNEL Long-term Inhalation value on human study = 0.28 mg/m3
4. Long-term exposure - local effects
No information on local effects (dermal and inhalation routes) are available.
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 0.02 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 0.2 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- n workers, the equivalent AP exposure level, calculated as 0.20 mg AP/kg/day, was a NOAEL
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 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
GENERAL POPULATION
1. Acute / short term exposure - systemic effects
Dermal route: Based on the available data, the substance is not classified for this endpoint (LD50>2000 mg/kg).
Inhalation route: Due to the lack of information for the inhalation route, no DNEL is derived.
Oral route: This substance is classified for this endpoint, but this route of exposure is not relevant for general population.
2. Acute / short term exposure - local effects
No information on local effects (dermal and inhalation routes) are available.
3. Long-term exposure - systemic effects
3.1 Dermal DNEL
The registered substance will not be made available to the general public and so derivation of the DNEL values for this population group was considered to be inappropriate.
3.2 Inhalation DNEL
The registered substance will not be made available to the general public and so derivation of the DNEL values for this population group was considered to be inappropriate.
3.3 Oral DNEL
In the cross sectional study of Bravermann (2005), 29 male workers exposed chronically to perchlorate, mainly by respiratory route, were investigated for perchlorate exposure level (based on serum and urine perchlorate concentrations) and a whole range of thyroid and hematological and biochemical endpoints. When comparing with normal limits, it could be concluded that no effect on T3, T4 and TSH, thyroid volume, thyroglobulin and urinary iodine excretion occurred at a median absorbed dose of 0.167 mg perchlorate ion/kg/day, over 5.9 years (median: chronic exposure) for 42h/week. Free T4 index was above normal limits in all groups but this is the opposite to the expected effect of perchlorate. Exposure of exposed workers was demonstrated by decreased radioiodine uptake and the detectable serum and urinary perchlorate levels (non-adverse effects).In workers, the equivalent AP exposure level, calculated as 0.20 mg AP/kg/day, was a NOAEL.
Step 1) Relevant dose-descriptor:NOAEL, human = 0.20 mg/kg bw/d
Step 2) Modification of starting point:No
Step 3) Assessment factors:
* Interspecies : no factor (human)
* Intraspecies : 10 (general population)
* Exposure duration : 1 (chronic study)
* Dose response: 1(NOAEL)
* Quality of database: 1
AF total = 10x1x1x1= 10
Step 4) DNEL derivation:
DNEL value = 0.20 / 10 = 0.02 mg/kg/d
DNEL Long-term Oral value based on human study = 0.02 mg/kg/d
4. Long-term exposure - local effects
No information on local effects (dermal and inhalation routes) are available.
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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