Registration Dossier
Registration Dossier
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EC number: 264-980-3 | CAS number: 64628-44-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.16 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.82 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:
The calculation of the DNEL is based on an oral NOAEL observed in a chronic repeated dose oral toxicity study in rats (NOAEL = 0.82 mg/kg bw/day).
To correct the interspecies difference between rat and human the no observed effect level has to be corrected as follows:
Corrected starting point for the inhalative route for workers:
= NOAEL(oral) * (1/0.38 m³/kg bw/day) * (ABSoral-rat/ABSinh-human) * 6.7 m³ (8h) /10 m³ (8h)* (7 days exposure rat/5 days exposure worker)
= 0.82 mg/kg bw/day * (1/0.38 m³/kg bw/day) * (1/1) * 0.67 m³ * 1.4= 2.02 mg/m³.
Oral absorption rate was measured to be > 80%. Therefore, no correction for oral absorption is needed and it can be assumed that oral and inhalation absorption are both around 100%.
(ABSoral-rat = oral absorption in rats, ABSinh-human = inhalation absorption rate in humans)
Thus, the corrected starting point for workers was 2.02 mg/m³ for inhalation.- Justification:
- The dose descriptor starting point is based on a NOAEL.
- Justification:
- The DNEL is based on a chronic study.
- Justification:
- An AF is not required as allometric factors are accounted for in modification of the starting point.
- Justification:
- Default value according to ECHA REACH Guidance.
- Justification:
- Default value for workers according to ECHA REACH Guidance.
- Justification:
- The DNEL is based on high-quality data set.
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
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:
- 0.56 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification of the dose descriptor starting point necessary because a dermal repeated dose toxicity study is available.
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- Justification:
- The DNEL is based on a sub-acute study.
- Justification:
- The experimental animal was a rabbit.
- Justification:
- Default value according to ECHA REACH Guidance.
- Justification:
- Default value for workers according to ECHA REACH Guidance.
- Justification:
- The DNEL is based on a high quality study.
- 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
- Most sensitive endpoint:
- repeated dose toxicity
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:
- 0.029 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.82 ng/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.71 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The calculation of the DNEL is based on an oral NOAEL observed in a chronic repeated dose oral toxicity study in rats (NOAEL = 0.82 mg/kg bw/day).
To correct the interspecies difference between rat and human the no observed effect level has to be corrected as follows:
Corrected starting point for the inhalative route for workers:
= NOAEL(oral) * (1/1.15 m³/kg bw/day (24h)) * (ABSoral-rat/ABSinh-human)
= 0.82 mg/kg bw/day * (1/1.15 m³/kg bw/day) * (1/1) = 0.71 mg/m³.
Oral absorption rate was measured to be > 80%. Therefore, no correction for oral absorption is needed and it can be assumed that oral and inhalation absorption are both around 100%.
(ABSoral-rat = oral absorption in rats, ABSinh-human = inhalation absorption rate in humans)
Thus, the corrected starting point for workers was 0.71 mg/m³ for inhalation.- Justification:
- The dose descriptor stating point is based on a NOAEL.
- Justification:
- The DNEL is based on a chronic study.
- Justification:
- An AF is not required as allometric factors are accounted for in modification of the starting point.
- Justification:
- Default value according to ECHA REACH Guidance.
- Justification:
- Default value for general population according to ECHA REACH Guidance.
- Justification:
- The DNEL is based on a high-quality data set.
- 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
- 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:
- 0.28 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification of the dose descriptor starting point necessary because a dermal repeated dose toxicity study is available.
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- Justification:
- The DNEL is based on a subacute study.
- Justification:
- The experimental animal was rabbit.
- Justification:
- Default value according to ECHA REACH Guidance.
- Justification:
- Default value for general population according to ECHA REACH Guidance.
- Justification:
- The DNEL is based on a high-quality study.
- 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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.082 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.82 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification of the dose descriptor starting point necessary because an oral repeated dose toxicity study is available.
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- Justification:
- The DNEL is based on a chronic study.
- Justification:
- The experimental animal was rat.
- Justification:
- Default value according to ECHA REACH Guidance.
- Justification:
- Default value for general population according to ECHA REACH Guidance.
- Justification:
- The DNEL is based on a set of high-quality studies.
- 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
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