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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
DNEL (Derived No Effect Level)
Value:
146 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: according to ECETOC 2003
Overall assessment factor (AF):
6
Modified dose descriptor starting point:
NOAEC
Value:
875 mg/m³
Explanation for the modification of the dose descriptor starting point:
no inhalation toxicity study available, worst case assumption based on oral results
AF for dose response relationship:
1
Justification:
according to ECETOC
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
already in starting point correction
AF for other interspecies differences:
3
Justification:
worker
AF for intraspecies differences:
1
Justification:
according to ECETOC
AF for the quality of the whole database:
1
Justification:
according to ECETOC
AF for remaining uncertainties:
1
Justification:
according to ECETOC
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
208.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: according to ECETOC 2003
Overall assessment factor (AF):
24
Modified dose descriptor starting point:
NOAEL
Value:
5 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
no dermal toxicity study available, assumption based on oral results and literature
AF for dose response relationship:
1
Justification:
according to ECETOC
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat -> human
AF for other interspecies differences:
3
Justification:
worker
AF for intraspecies differences:
1
Justification:
according to ECETOC
AF for the quality of the whole database:
1
Justification:
according to ECETOC
AF for remaining uncertainties:
1
Justification:
according to ECETOC
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:
medium hazard (no threshold derived)

Additional information - workers

Based on a comparison of the different available studies the most reliable and relevant NOEAL for the derivations of a DNEL can be obtained from the following studies:

 

Most sensitive record for systemic effects is:

Subchronic study, rats, 90 days, OECD 408: NOAEL (f/m, systemic, rat) = 500 mg/kg bw/day (A.I., highest tested dosage) (HENKEL/COGNIS.R9400320, 1995)

 

Most sensitive record for local effects:

Only very less skin effects (HENKEL/COGNIS. R9700923)

Severe eye effects observed, mild to strong signs at 50%, no reversible till 21d (HENKEL/COGNIS.TDB900762)

No sensitisation (HENKEL/COGNIS.R9701260)

 

All DNEL were derived using, if necessary, route-to-route extrapolation as there is no adequate subacute/subchronic studies for dermal or inhalation available.

The information available points to a moderate to severe eye effect. One of the available studies (which is therefore assumed as key study) shows irreversible effects on the iris. This severity could be not confirmed in another study. But nevertheless as both tests were not conducted with 100% As the registrant believes in a worst case approach that severe and maybe irreversible effects are possible also more likely for 100% AS. Therefore the substance should be regarded as severely irritating to eye GHS cat. 1. 

Qualitative CSA:

The available data for eye irritation do not provide quantitative dose-response information; thus, no short-term local DNELs have been derived for dermal exposure and no quantitative risk assessment was performed. Exposure assessment and risk characterization are performed on a qualitative basis.

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
43.8 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: according to ECETOC 2003
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEC
Value:
437.5 mg/m³
Explanation for the modification of the dose descriptor starting point:
no inhalation toxicity study available, worst case assumption based on oral results
AF for dose response relationship:
1
Justification:
according to ECETOC
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
already in starting point correction
AF for other interspecies differences:
5
Justification:
general pop.
AF for intraspecies differences:
1
Justification:
according to ECETOC
AF for the quality of the whole database:
1
Justification:
according to ECETOC
AF for remaining uncertainties:
1
Justification:
according to ECETOC
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
125 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: according to ECETOC 2003
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
Value:
5 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
no dermal toxicity study available, assumption based on oral results and literature
AF for dose response relationship:
1
Justification:
according to ECETOC
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat -> human
AF for other interspecies differences:
5
Justification:
general pop.
AF for intraspecies differences:
1
Justification:
according to ECETOC
AF for the quality of the whole database:
1
Justification:
according to ECETOC
AF for remaining uncertainties:
1
Justification:
according to ECETOC
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: according to ECETOC 2003
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
no extrapolation
AF for dose response relationship:
1
Justification:
according to ECETOC
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat -> human
AF for other interspecies differences:
5
Justification:
general pop.
AF for intraspecies differences:
1
Justification:
according to ECETOC
AF for the quality of the whole database:
1
Justification:
according to ECETOC
AF for remaining uncertainties:
1
Justification:
according to ECETOC
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

Based on a comparison of the different available studies the most reliable and relevant NOEAL for the derivations of a DNEL can be obtained from the following studies:

 

Most sensitive record for systemic effects is:

Subchronic study, rats, 90 days, OECD 408: NOAEL (f/m, systemic, rat) = 500 mg/kg bw/day (A.I., highest tested dosage) (HENKEL/COGNIS.R9400320, 1995)

 

Most sensitive record for local effects:

Only very less skin effects (HENKEL/COGNIS. R9700923)

Severe eye effects observed, mild to strong signs at 50%, no reversible till 21d (HENKEL/COGNIS.TDB900762)

No sensitisation (HENKEL/COGNIS.R9701260)

 

All DNEL were derived using, if necessary, route-to-route extrapolation as there is no adequate subacute/subchronic studies for dermal or inhalation available.

The information available points to a moderate to severe eye effect. One of the available studies (which is therefore assumed as key study) shows irreversible effects on the iris. This severity could be not confirmed in another study. But nevertheless as both tests were not conducted with 100% As the registrant believes in a worst case approach that severe and maybe irreversible effects are possible also more likely for 100% AS. Therefore the substance should be regarded as severely irritating to eye GHS cat. 1. 

Qualitative CSA:

The available data for eye irritation do not provide quantitative dose-response information; thus, no short-term local DNELs have been derived for dermal exposure and no quantitative risk assessment was performed. Exposure assessment and risk characterization are performed on a qualitative basis.

But nevertheless as there are no consumer uses, therefore no qualitative risk assessment for consumer concerning eye irriation is performed.