Registration Dossier
Registration Dossier
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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 480-340-8 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.162 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:
- 2.309 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 4.041 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No long-term exposure data are available for the inhalation route therefore the NOAEL resulted from an animal study were ammonium perchlorate was given in drinking water for 90 days is used. The NOAEL resulted (1.0 mg/kg bw/day) corresponds to ammonium perchlorate doses. Readjusting the NOAEL to the substance dose, the NOAEL results as 2.309 mg/kg bw/day.
Route-to-route extrapolation is therefore needed from the oral to the inhalation route.
The NOAEL rat is converted to NOAEL human by dividing with the allometric scalling factor 4 for interspecies differences. By multiplying the NOAEL human with the default human body weight (70 kg) and dividing the default human breathing volume referring to workers (10 m3 in 8h and light activity), this dose is then translated into an air concentration. The absorption rate for human via inhalation is not known for perchlorate. It is assumed that absorption rate via inhalation route is similar to absorption rate via oral route.
NOAELoral= 2.309 mg/kg b.w
Standard human body weight = 70 kg
Default human breathing volume for workers in 8 hours = 10 m3
Therefore, NOAECinh= (2.309/4)* (70/10) = 4.041 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- The starting point for the DNEL derivation is a NOAEL; default factor AF=1 is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The duration of the animal study is 90 days. Extrapolation needed from subchronic to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scalling is already taken into consideration during the route-to-route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences).
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers is applied.
- AF for the quality of the whole database:
- 1
- Justification:
- Good/standard quality of database.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.55 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 455.12 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL obtained by a repeated dose toxicity via the dermal route on trtriethanolamine is used.
The NOAEL for systemic effects resulted (250.0 mg/kg bw/day) corresponds to triethanolamine doses. Readjusting the NOAEL to the substance dose, the NOAELmodified results as 455.12 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used; default AF is 1.
- AF for differences in duration of exposure:
- 2
- Justification:
- Adjustment from sub-chronic to chronic duration
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Extrapolation from rats to humans
- AF for other interspecies differences:
- 2.5
- Justification:
- No substance-specific data are available; the additional factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate - small part- and toxicodynamic differences - larger part).
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers is applied.
- AF for the quality of the whole database:
- 1
- Justification:
- Good/standard quality of database.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.26 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- other: NOAELmodified
- Value:
- 1.278 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- The starting point for the DNEL derivation is a NOEL; default factor AF=1 is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- For local dermal effects, increasing the exposure duration does not increase the severity of incidence of effects.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No adjustment for direct chemical reactivity with membrane
- AF for other interspecies differences:
- 1
- Justification:
- No adjustment for direct chemical reactivity with membrane
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Good/standard quality of database.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium 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:
- 0.041 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:
- 2.309 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2.02 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No long-term exposure data are available for the inhalation route therefore the NOAEL resulted from an animals study were ammonium perchlorate was given in drinking water for 90 days is used. The NOAEL resulted (1.0 mg/kg bw/day) corresponds to ammonium perchlorate doses. Readjusting the NOAEL to the substance dose, the NOAEL results as 2.309 mg/kg bw/day.
Route-to-route extrapolation is therefore needed from the oral to the inhalation route. The NOAEL rat is converted to NOAEL human by dividing with the allometric scalling factor 4 for interspecies differences. By multiplying the NOAEL human with the default human body weight (70 kg) and dividing by the default human breathing volume referring to general public (20 m3 in 24 hours and basal caloric demand), this dose is then translated into an air concentration. The absorption rate for human via inhalation is not known for perchlorate. It is assumed that absorption rate via inhalation route is similar to absorption rate via oral route.
NOAELoral = 2.309 mg/kg b.w
Standard human body weight = 70 kg
Default human breathing volume for general pobulation in 24 hours = 20 m3
Allometric scalling factor for rats as compared to humans = 4
Therefore, NOAECinh= (2.309/4)* (70/20) = 2.020 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- The starting point for the DNEL derivation is a NOAEL; default factor AF=1 is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The duration of the animal study is 90 days. Extrapolation needed from subchronic to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scalling is already taken into consideration during the route-to-route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences).
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population is applied.
- AF for the quality of the whole database:
- 1
- Justification:
- Good/standard quality of database.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.28 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 455.12 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL obtained by a repeated dose toxicity via the dermal route on trtriethanolamine is used.
The NOAEL for systemic effects resulted (250.0 mg/kg bw/day) corresponds to triethanolamnie doses. Readjusting the NOAEL to the substance dose, the NOAELmodified results as 455.12 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used; default AF is 1.
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation for sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- No adjustment for direct chemical reactivity with membrane
- AF for other interspecies differences:
- 2.5
- Justification:
- No adjustment for direct chemical reactivity with membrane
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Good/standard quality of database
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.13 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor:
- other: NOAELmodified
- Value:
- 1.278 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used; default AF is 1.
- AF for differences in duration of exposure:
- 1
- Justification:
- For local dermal effects, increasing the exposure duration does not increase the severity of incidence
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No adjustment for direct chemical reactivity with membrane
- AF for other interspecies differences:
- 1
- Justification:
- No adjustment for direct chemical reactivity with membrane
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Good/standard quality of database
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.011 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2.309 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL resulted from an animal study where rats were given ammonium perchlorate in drinking water. The NOAEL resulted (1.0 mg/kg bw/day) therefore corresponds to ammonium perchlorate doses. Readjusting the NOAEL to the substance dose, the NOAELmodified results as 2.309 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- The starting point for the DNEL derivation is a NOAEL; default factor AF=1 is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation for sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scalling fromm rat to humans
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences).
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population is applied.
- AF for the quality of the whole database:
- 1
- Justification:
- Good/standard quality of database.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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.
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.
