Registration Dossier
Registration Dossier
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EC number: 217-496-1 | CAS number: 1873-88-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.7 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 353 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The DNEL for repeated dose effects via the inhalation route is determined on the basis of route-to-route extrapolation from the oral OECD 422 study. In this study a NOAEL of 200 mg/kg bw was derived based on effects relevant for humans. The following corrections were made to the NOAEL (oral): Correction for respiratory volume rat (8 hour): 1/0.38 m³/kg bw/d (default).
Correction for respiratory rate and volume (human worker): 6.7 m ³/d/10 m ³/d (default). Therefore, the corrected NOAEC for toxicity via the inhalation route is: 200*(1/0.38)*(6.7 m ³/d /10 m ³/d) = 353 mg/m ³.
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL was established
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (inhalation route)
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- The available study was conducted according to relevant OECD test guideline, and in accordance with GLP
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- 66.7 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 20 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The DNEL for developmental effects via the dermal route is determined on the basis of route-to-route extrapolation from the oral OECD Test Guideline 422 study. In this study a NOAEL of 200 mg/kg bw/day was derived based on effects relevant for humans. In practice, dermal absorption of this substance is very limited. A further correction for the known dermal absorption of 1% has been made, with the additional factor of 100: 200 mg/kg bw/day x 100 = 20000 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL was established
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (rat to human)
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- The available study was conducted according to a relevant OECD test guideline, and in accordance with GLP
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.16 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 173.91 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The DNEL for repeated dose effects via the inhalation route is determined on the basis of route-to-route extrapolation from the oral OECD Test Guideline 422 study. In this study a NOAEL of 200 mg/kg bw was derived based on effects relevant for humans. The following correction was made to the NOAEL (oral): Correction respiratory volume rat (24 hour) = 1/1.15 m³/kg bw. Therefore, the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 200*(1/1.15) = 173.91 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (subacute to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (oral rat to inhaled human)
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- The available study was conducted in accordance with an appropriate OECD test guideline and in compliance with GLP.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
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:
- 0.3 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic effects via the oral route is determined using the key oral OECD Test Guideline 422 study. In this study a NOAEL of 200 mg/kg bw/day was derived. No correction was made to the NOAEL.
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL was established
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (rat to human)
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- The available study was conducted in accordance with an appropriate OECD test guideline and in compliance with GLP.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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
There are no consumer uses of HL3 therefore DNELs for the dermal route is not required for the general population. A DNEL for the oral and inhalation route is calculated for the purposes of assessing exposure of man via the environment.
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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