Registration Dossier
Registration Dossier
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EC number: 221-361-2 | CAS number: 3077-27-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.47 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:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 123.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
inhalation NOAEC = NOAELoral*(1/0.38 m³/kg bw/day)*(ABSoral-rat/ABSinh-human)*(6.7 m³ (8h)/10 m³ (8h))*(fexpo,rat/fexpo,worker) = 100 mg/kg bw/day*(1/0.38 m³/kg bw/day)*(0.5/1)*0.67*(7/5) = 123.4 mg/m³
ABSoral-rat = oral absorption rate in rats
ABSinh-human = inhalation absorption rate in humans
fexpo,rat = exposure frequency rats = 7 days/week
fexpo,worker = exposure frequency worker = 5 days/week
In a worst case approach the default oral absorption rate of 50% for the rat was used in the calculations (default 0.5/1 according to ECHA Guidance on Information Requirements and Chemical Safety Assessment - Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is starting point
- AF for differences in duration of exposure:
- 4
- Justification:
- An assessment factor of 4 is used. According to the ECHA Guidance on Information Requirements and Chemical Safety Assessment - Chapter R.8: Characterisation of dose [concentration]-response for human health), the default value for subacute (28-day) to chronic conversion is 6 and the default assessment factor for subchronic (90-day) to chronic conversion is 2. Since the oral NOAEL used to derive the inhalation NOAEC was determined in an oral combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (according to OECD TG 422) based on effects observed in female rats which have been dosed for 50 - 60 days, an assessment factor of 6 (reflecting 28-day exposure) is considered too conservative. Due to the fact that the real exposure time of the rats is approx. 61% of that of a subchronic (90-day) study, an assessment factor of 4 is considered to reflect the exposure situation in the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (according to OECD TG 422) in a more realistic way.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF for allometric scaling already included in starting point derivation method; no further factor required.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 5
- Justification:
- Default value (worker)
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.7 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 140 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal NOAEL=NOAELoral*(ABSoral-rat/ABSdermal-human)*(fexpo,rat/fexpo,worker) = 100 mg/kg bw/day*(1/1)*(7/5) = 140 mg/kg bw/day
ABSoral-rat = oral absorption rate in rats,
ABSdermal-human = dermal absorption rate in humans
fexpo,rat = exposure frequency rats = 7 days/week
fexpo,worker = exposure frequency worker = 5 days/week
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is starting point
- AF for differences in duration of exposure:
- 4
- Justification:
- An assessment factor of 4 is used. According to the ECHA Guidance on Information Requirements and Chemical Safety Assessment - Chapter R.8: Characterisation of dose [concentration]-response for human health), the default value for subacute (28-day) to chronic conversion is 6 and the default assessment factor for subchronic (90-day) to chronic conversion is 2. Since the oral NOAEL used to derive the inhalation NOAEC was determined in an oral combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (according to OECD TG 422) based on effects observed in female rats which have been dosed for 50 - 60 days, an assessment factor of 6 (reflecting 28-day exposure) is considered too conservative. Due to the fact that the real exposure time of the rats is approx. 61% of that of a subchronic (90-day) study, an assessment factor of 4 is considered to reflect the exposure situation in the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (according to OECD TG 422) in a more realistic way.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value (rat -> human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 5
- Justification:
- Default value (worker)
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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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