Registration Dossier
Registration Dossier
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EC number: 700-233-4 | 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:
- 9.98 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
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:
- 1.17 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
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
1. Relevant Toxicology Data, exposure pattern and route
The calculation of the DNEL is based on the results of a Combined Repeated Oral Dose and reproduction Toxicity study (OECD 422) in rats. A NOAEL for systemic toxicity was established at 350 mg/kg bw.
2. Mode of action
No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic potential.
3. Correction of dose descriptor
NOAEL (oral) is converted into a NOAEL(corrected)in accordance to Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose[concentration]-response for human health, ECHA, May 2008.
Dermal: NOAEL (oral) = 350 mg/kg bw =>NAEC(corrected) = 350mg/kg
Inhalation: NOAEL (oral) = 350 mg/kg bw =>NAEC(corrected) = 299.6 mg/m3
Assumption: Absorption oral = absorption dermal = 1/2 absorption inhalation.
4. Application of assessment factors
The following assessment factors were chosen:
Dermal:
Intraspecies differences account for a factor of 4. Since a subchronic study in the rat was assigned as key study,
a factor of 5 for intraspecies difference
a factor of 6 for exposure duration was used.
a factor of 2.5 for an additional factor for residual interspecies differences
a factor of 1 for the quality of dataset.
Inhalation:
Intraspecies differences account for a factor of 1
a factor of 6 for exposure duration was used.
a factor of 5 for interspecies differences
a factor of 1 for the quality of dataset. .
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.54 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 60
- Modified dose descriptor starting point:
- NOAEC
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.58 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
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:
- 0.58 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
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
1. Relevant Toxicology Data, exposure pattern and route
The calculation of the DNEL is based on the results of a Combined Repeated Oral Dose and reproduction Toxicity study (OECD 422) in rats. A NOAEL for systemic toxicity was established at 350 mg/kg bw.
2. Mode of action
No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic potential.
3. Correction of dose descriptor
NOAEL (oral) is converted into a NOAEL(corrected)in accordance to Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose[concentration]-response for human health, ECHA, May 2008.
Dermal: NOAEL (oral) = 350 mg/kg bw =>NAEC(corrected) = 350mg/kg
Inhalation: NOAEL (oral) = 350 mg/kg bw =>NAEC(corrected) = 299.6 mg/m3
Assumption: Absorption oral = absorption dermal = 1/2 absorption inhalation.
4. Application of assessment factors
The following assessment factors were chosen:
Dermal:
Intraspecies differences account for a factor of 4. Since a subchronic study in the rat was assigned as key study,
a factor of 10 for intraspecies difference
a factor of 6 for exposure duration was used.
a factor of 2.5 for an additional factor for residual interspecies differences
a factor of 1 for the quality of dataset.
Inhalation:
Intraspecies differences account for a factor of 1
a factor of 6 for exposure duration was used.
a factor of 10 for interspecies differences
a factor of 1 for the quality of dataset. .
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