Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11 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:
264 mg/m³
Explanation for the modification of the dose descriptor starting point:
300 mg/kg/day x (1/0.38) x (50 oral abs/100 inhalation abs) x (6.7/10)
AF for dose response relationship:
1
Justification:
No adverse effects observed in repeat dose, reproductive toxicity studies, or genetox
AF for differences in duration of exposure:
2
Justification:
Default factor for subchronic to chronic study extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
Already taken into account during the correction of starting point
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining toxicodynamic differences
AF for intraspecies differences:
5
Justification:
Default factor for workers
AF for the quality of the whole database:
1
Justification:
Database appropriate for tonnage. 2 species utilised in repeat dose toxicity.
AF for remaining uncertainties:
1
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
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
15 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):
100
Modified dose descriptor starting point:
NOAEL
Value:
1 500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
300 mg/kg bw/day x (50% oral abs/10% derm abs)
AF for dose response relationship:
1
Justification:
No adverse effects observed in repeat dose, reproductive toxicity studies, or genetox
AF for differences in duration of exposure:
2
Justification:
Default factor for subchronic to chronic study extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor for extrapolating toxicokinetics from Rat to Human
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining toxicodynamic differences
AF for intraspecies differences:
5
Justification:
Default factor for workers
AF for the quality of the whole database:
1
Justification:
Database appropriate for tonnage. 2 species utilised in repeat dose toxicity.
AF for remaining uncertainties:
1
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

In reliable 90 day dietary studies in the rat and the dog the NOEL were the top doses tested (3000 ppm). This dose level was converted to a bodyburden of 300 mg/kg bw/day by using a conversion factor of 0.1. In acute oral, dermal and inhalation toxicity studies no adverse effects were observed at the limit dose in the dermal toxicity study, at 10 g/kg in the oral study or at 2 mg/L in the inhalation study. No local tolerance issues were identified from skin irritation, skin sensitisation, eye irritation or acute inhalation toxicity studies. The NOEL for all effects in the OECD 421 reproduction screen conducted was to top dose tested, 1000 mg/kg bw/day.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.6 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:
130 mg/m³
Explanation for the modification of the dose descriptor starting point:
300 x (1/1.15) x (50% oral abs/100% inhal abs)
AF for dose response relationship:
1
Justification:
No adverse effects observed in repeat dose, reproductive toxicity studies, or genetox
AF for differences in duration of exposure:
2
Justification:
Default factor for subchronic to chronic study extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
Already taken into account during the correction of starting point
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining toxicodynamic differences
AF for intraspecies differences:
10
Justification:
Default factor for the general population
AF for the quality of the whole database:
1
Justification:
Database appropriate for tonnage. 2 species utilised in repeat dose toxicity.
AF for remaining uncertainties:
1
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
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.5 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:
1 500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
300 mg/kg bw/day x (50% oral abs/10% derm abs)
AF for dose response relationship:
1
Justification:
No adverse effects observed in repeat dose, reproductive toxicity studies, or genetox
AF for differences in duration of exposure:
2
Justification:
Default factor for subchronic to chronic study extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor for extrapolating toxicokinetics from Rat to Human
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining toxicodynamic differences
AF for intraspecies differences:
10
Justification:
Default factor for the general population
AF for the quality of the whole database:
1
Justification:
Database appropriate for tonnage. 2 species utilised in repeat dose toxicity
AF for remaining uncertainties:
1
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:
1.5 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:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
None
AF for dose response relationship:
1
Justification:
No adverse effects observed in repeat dose, reproductive toxicity studies, or genetox
AF for differences in duration of exposure:
2
Justification:
Default factor for subchronic to chronic study extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor for extrapolating toxicokinetics from Rat to Human
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining toxicodynamic differences
AF for intraspecies differences:
10
Justification:
Default factor for the general population
AF for the quality of the whole database:
1
Justification:
Database appropriate for tonnage. 2 species utilised in repeat dose toxicity
AF for remaining uncertainties:
1
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

In reliable 90 day dietary studies in the rat and the dog the NOEL were the top doses tested (3000 ppm). This dose level was converted to a bodyburden of 300 mg/kg bw/day by using a conversion factor of 0.1. In acute oral, dermal and inhalation toxicity studies no adverse effects were observed at the limit dose in the dermal toxicity study, at 10 g/kg in the oral study or at 2 mg/L in the inhalation study. No local tolerance issues were identified from skin irritation, skin sensitisation, eye irritation or acute inhalation toxicity studies. The NOEL for all effects in the OECD 421 reproduction screen conducted was to top dose tested, 1000 mg/kg bw/day.