Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.5 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
2
Dose descriptor:
NOAEC
Value:
3 mg/m³
AF for dose response relationship:
1
Justification:
Effect is concentration dependant irritation of the respiratory tract
AF for differences in duration of exposure:
1
Justification:
Effects observed are concentration dependant not time dependant
AF for interspecies differences (allometric scaling):
1
Justification:
Effects are concentration dependant i.e. direct irritation of the lining of the respiratory tract
AF for other interspecies differences:
1
Justification:
No other interspecies differences expected since the MOA is direct irritation of the lining of the respiratory tract
AF for intraspecies differences:
2
Justification:
No biotransformation, enzyme or receptor polymorphisms or other major intraspecies variabilities are expected. Furthermore, the signs observed in the repeat dose inhalation study are considered very minor adaptations that were reversible.
AF for the quality of the whole database:
1
Justification:
Reliable guideline and GLP studies conducted
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1
DNEL extrapolated from long term DNEL
Dose descriptor starting point:
NOAEC
Value:
3 mg/m³

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:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation 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:
DNEL (Derived No Effect Level)
Value:
1 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
3
Dose descriptor:
NOAEC
Value:
3 mg/m³
AF for dose response relationship:
1
Justification:
Effects observed are considered concentration dependant (threshold) effects
AF for differences in duration of exposure:
1
Justification:
Effects observed are considered concentration dependant not time dependant therefore an additional assessment factor for exposure duration is not warranted
AF for interspecies differences (allometric scaling):
1
Justification:
Effects observed are direct irritation of the lining of the respiratory tract which require no biotransformation or metabolic activation. Furthermore, rats are obligate nasal breathers with a more rapid breathing rate than humans and as such the irritant effects would be exacerbated.
AF for other interspecies differences:
1
Justification:
No other interspecies differences expected since the MOA is direct irritation of the lining of the respiratory tract
AF for intraspecies differences:
3
Justification:
No biotransformation, enzyme or receptor polymorphisms or other major intraspecies variabilities are expected since the effects observed in repeat dose inhalation studies were direct irriation of the lining of the respiratory tract which is considered oconcentration and not time dependant (i.e. doesn't follow Haber's Law). Furthermore, the signs observed in the repeat dose inhalation study are considered very minor adaptations that were reversible.
AF for the quality of the whole database:
1
Justification:
Guideline compliant GLP studies conducted and used for derivation of the DNEL
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
3
Dose descriptor starting point:
NOAEC
Value:
3 mg/m³
AF for dose response relationship:
1
Justification:
Effects observed are considered concentration dependant (threshold) effects
AF for interspecies differences (allometric scaling):
1
Justification:
No other interspecies differences expected since the MOA is direct irritation of the lining of the respiratory tract
AF for other interspecies differences:
1
Justification:
Effects observed are direct irritation of the lining of the respiratory tract which require no biotransformation or metabolic activation. Furthermore, rats are obligate nasal breathers with a more rapid breathing rate than humans and as such the irritant effects would be exacerbated.
AF for intraspecies differences:
3
Justification:
No biotransformation, enzyme or receptor polymorphisms or other major intraspecies variabilities are expected since the effects observed in repeat dose inhalation studies were direct irriation of the lining of the respiratory tract which is considered oconcentration and not time dependant (i.e. doesn't follow Haber's Law). Furthermore, the signs observed in the repeat dose inhalation study are considered very minor adaptations that were reversible.
AF for the quality of the whole database:
1
Justification:
Guideline compliant GLP studies conducted and used for derivation of the DNEL
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
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:
25 mg/kg bw/day
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
Dose descriptor starting point is taken from a 2 year carcinogenicity study conducted in rats therefore no AF warranted
AF for interspecies differences (allometric scaling):
4
Justification:
Standard factor Rat - Human
AF for other interspecies differences:
1
Justification:
Very low intestinal absoprtion rate of <5% justifies no additional factor
AF for intraspecies differences:
5
Justification:
Minimal absorption of the material in the itestinal tract and lack of biotransformation support reduction of standard AF from 10 to 5
AF for the quality of the whole database:
1
Justification:
DNEL derived from well conducted carcinogenicity study performed via the diet. No further AF warranted
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