Registration Dossier
Registration Dossier
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EC number: 285-089-6 | CAS number: 85029-63-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 29.4 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):
- 30
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 881.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The original study is reliable without restrictions.
The route to route extrapolation was performed by applying the equation as cited in Guidance on information requirements and chemical safety assessment, Chapter R.8 (by ECHA) with all recommended assessment factors.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is the starting point for DNEL derivation. According to Guidance on information Chapter R.8, p. 30, the assessment factor is 1.
- AF for differences in duration of exposure:
- 6
- Justification:
- according to Guidance on information Chapter R.8, Table 8-6, p. 32 (males were exposed for 37 days)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Interspecies difference is included in the calculation by correcting the respiratory volumes of rat and
man (for details refer to "explanation for hazard conclusion") - AF for other interspecies differences:
- 1
- Justification:
- Interspecies difference is included in the calculation by correcting the respiratory volumes of rat and
man (for details refer to "explanation for hazard conclusion") - AF for intraspecies differences:
- 5
- Justification:
- According to Guidance on information Chapter R.8, Table 8-6, p. 32
- AF for the quality of the whole database:
- 1
- Justification:
- Default according to Guidance on information Chapter R.8, Table 8-6, p. 32
- AF for remaining uncertainties:
- 1
- Justification:
- Default according to Guidance on information Chapter R.8, Table 8-6, p. 32
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
There is no information on lethality after acute inhalation exposure, however, no mortality was observed in an oral acute toxicity study up to 2000 mg/kg bw, the highest concentration tested; i. e.
consideration in a qualitative risk assessment is not necessary. Based on these information no hazard for systemic effects after acute inhalation exposure could be identified.
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:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
please refer to "explanation for hazard conclusion" of each hazard point
The substance is classified for human health as skin sensitiser Cat. 1B (H317: May cause an allergic skin reaction.). No DNEL for systemic effects is derived since the skin sensitising properties of the substance determine the hazard and risk profile.
Otherwise, dermal systemic exposure would have to be calculated, which would then assume (even if gloves are worn) some dermal exposure to the substance. This cannot reflect the real situation since the skin would suffer from the sensitising effects. Rather than calculating some dermal exposure potentially leading to systemic effects and discounting these results afterwards on the basis of the sensitising effects, it is more appropriate to base the dermal assessment entirely on the qualitative risk characterisation for a sensitizing substance. Based on the classification (Skin Sensitising Cat. 1B) and the hazard statement a medium hazard band for the qualitative assessment is assumed.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.2 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):
- 60
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 434.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The original study is reliable without restrictions.
The route to route extrapolation was performed by applying the equation as cited in Guidance on information requirements and chemical safety assessment, Chapter R.8 (by ECHA) with all recommended assessment factors.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is the starting point for DNEL derivation. According to Guidance on information Chapter R.8, p. 30, the assessment factor is 1.
- AF for differences in duration of exposure:
- 6
- Justification:
- according to Guidance on information Chapter R.8, Table 8-6, p. 32
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Interspecies difference is included in the calculation by correcting the respiratory volumes of rat and man (for details refer to "explanation for hazard conclusion")
- AF for other interspecies differences:
- 1
- Justification:
- interspecies difference is included in the calculation by correcting the respiratory volumes of rat and man (for details refer to "explanation for hazard conclusion")
- AF for intraspecies differences:
- 10
- Justification:
- according to Guidance on information Chapter R.8, Table 8-6, p. 32
- AF for the quality of the whole database:
- 1
- Justification:
- Default according to Guidance on information Chapter R.8, Table 8-6, p. 32
- AF for remaining uncertainties:
- 1
- Justification:
- Default according to Guidance on information Chapter R.8, Table 8-6, p. 32
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:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.2 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):
- 240
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The original study is reliable without restrictions. No modification of dose descriptor starting point needed since original study used oral route.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is the starting point for DNEL derivation. According to Guidance on information Chapter R.8, p. 30, the assessment factor is 1.
- AF for differences in duration of exposure:
- 6
- Justification:
- according to Guidance on information Chapter R.8, Table 8-6, p. 32
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- according to Guidance on information Chapter R.8, Table 8-6, p. 32
- AF for other interspecies differences:
- 1
- Justification:
- no additional AF for interspecies differences assumed
- AF for intraspecies differences:
- 10
- Justification:
- according to Guidance on information Chapter R.8, Table 8-6, p. 32
- AF for the quality of the whole database:
- 1
- Justification:
- Default according to Guidance on information Chapter R.8, Table 8-6, p. 32
- AF for remaining uncertainties:
- 1
- Justification:
- Default according to Guidance on information Chapter R.8, Table 8-6, p. 32
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
please refer to "explanation for hazard conclusion" of each hazard point
The substance is classified for human health as skin sensitiser Cat. 1B (H317: May cause an allergic skin reaction.). No DNEL for systemic effects is derived since the skin sensitising properties of the substance determine the hazard and risk profile.
Otherwise, dermal systemic exposure would have to be calculated, which would then assume (even if gloves are worn) some dermal exposure to the substance. This cannot reflect the real situation since the skin would suffer from the sensitising effects. Rather than calculating some dermal exposure potentially leading to systemic effects and discounting these results afterwards on the basis of the sensitising effects, it is more appropriate to base the dermal assessment entirely on the qualitative risk characterisation for a sensitizing substance. Based on the classification (Skin Sensitising Cat. 1B) and the hazard statement a medium hazard band for the qualitative assessment is assumed.
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