Registration Dossier
Registration Dossier
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EC number: 700-945-5 | 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:
- 24.7 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):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 616.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Figure R.8-3 of ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (Version 2.1; November 2012)
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor applied because starting point for DNEL calculation is a NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on administration of test material to the rat for 90 days (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not required because differences in breathing between rat and human already accounted for during modification of starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- Default correction for other interspecies differences to allow for variation in toxicokinetics and toxicodynamics
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- The starting point NOAEL was obtained from a GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- No other assessment factor is considered necessary
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:
- 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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The substance is not acutely toxic via the oral or dermal routes (LD50 > 2000 mg/kg) and no systemic effects were found at the highest dose level of 1000 mg/kg bw/day in 28-day studies via the oral or dermal routes. Dermal irritation/corrosion leading to classification was not apparent and no evidence of sensitisation has been reported. Oral administration of the test item to rats for a minimum of 90 consecutive days resulted in effects that may be relevant to humans (NOAEL 500 mg/kg bw/day for males with no effect at the highest dose of 750 mg/kg bw/day in females). However, these data did not lead to classification because the effect level was outside the guideline band of 10 to 100 mg/kg bw/day given in ECHA Guidance on the Application of the CLP Criteria (Version 4.1; June 2015). Calculation of systemic DNELs is therefore based on the worst case NOAEL of 500 mg/kg bw/day from the 90-day repeated dose oral toxicity study.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.3 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 215 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Figure R.8-3 of ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (Version 2.1; November 2012)
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor applied because starting point for DNEL calculation is a NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on administration of test material to the rat for 90 days (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not required because differences in breathing between rat and human already accounted for during modification of starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- Default correction for other interspecies differences to allow for variation in toxicokinetics and toxicodynamics
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- The starting point NOAEL was obtained from a GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- No other assessment factor is considered necessary
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:
- 2.5 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Route to route extrapolation not required
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor applied because starting point for DNEL calculation is a NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on administration of test material to the rat for 90 days (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling to correct for differences in metabolic rate (rat to human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default correction for other interspecies differences to allow for variation in toxicokinetics and toxicodynamics
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- The starting point NOAEL was obtained from a GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- No other assessment factor is considered necessary
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
The substance is not acutely toxic via the oral or dermal routes (LD50 > 2000 mg/kg) and no systemic effects were found at the highest dose level of 1000 mg/kg bw/day in 28-day studies via the oral or dermal routes. Dermal irritation/corrosion leading to classification was not apparent and no evidence of sensitisation has been reported. Oral administration of the test item to rats for a minimum of 90 consecutive days resulted in effects that may be relevant to humans (NOAEL 500 mg/kg bw/day for males with no effect at the highest dose of 750 mg/kg bw/day in females). However, these data did not lead to classification because the effect level was outside the guideline band of 10 to 100 mg/kg bw/day given in ECHA Guidance on the Application of the CLP Criteria (Version 4.1; June 2015). Calculation of systemic DNELs is therefore based on the worst case NOAEL of 500 mg/kg bw/day from the 90-day repeated dose oral toxicity study.
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