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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2.35 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):
75
Dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
196.3 mg/m³
Explanation for the modification of the dose descriptor starting point:

The starting point for DNEL derivation is the NOAEL of 200 mg/kg bw/d from the 28 day oral study.

For workers, the corrected inhalatory NOAEC is 200 mg/kg bw/d * sRVrat-1* Absoral rat/Absinh human*

sRVhuman/wRV; i.e. 200 mg/kg bw/d * (0.38m3/kg bw/d)-1* (50/100) * (6.7 m3/10m3). This gives a

modified inhalation starting point (NOAEC) of 196.3 mg/m3

AF for dose response relationship:
1
Justification:
Starting point is an adjusted NOAEC which was from a good quality modern study
AF for differences in duration of exposure:
6
Justification:
Extrapolation from a sub-acute study to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
Use of an allometric scaling factor is not appropriate where route to route extrapolation is used since
the species differences are accounted for in the breathing rate adjustments in the calculation.
AF for other interspecies differences:
2.5
Justification:
Default value for toxicokinetics and toxicodynamic interspecies differences
AF for intraspecies differences:
5
Justification:
Default value for workers
AF for the quality of the whole database:
1
Justification:
Default value; good quality database
AF for remaining uncertainties:
1
Justification:
Default value; no significant remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information
Explanation for the modification of the dose descriptor starting point:

The substance is clasified as Category 4 based on GHS criteria for acute oral toxicity; there are no data from an inhalation study. There is considered to be low hazard and a DNEL for acute systemic effects is not required. It is noted that the substance is classified as corrosive and sensitizing; therefore the potential for inhalation exposure will be limited through the use of engineering controls and suitable protective equipment.

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.666 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):
300
Dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting point for DNEL derivation is the NOAEL of 000 mg/kg bw/d from the 28 day oral toxicity study.

In the absence of specific data and following the default assumption that dermal absorption is equal to

oral absorption, the corrected dermal NOAEL is 100 mg/kg bw/d.

AF for dose response relationship:
1
Justification:
Starting point is an adjusted NOAEC which was from a good quality modern study
AF for differences in duration of exposure:
6
Justification:
Extrapolation from a sub-acute study to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Starting point is derived from a study in the rat.
AF for other interspecies differences:
2.5
Justification:
Default value for toxicokinetics and toxicodynamic interspecies differences
AF for intraspecies differences:
5
Justification:
Default value for workers
AF for the quality of the whole database:
1
Justification:
Default value; good quality database
AF for remaining uncertainties:
1
Justification:
Default value; no significant remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information
Explanation for the modification of the dose descriptor starting point:

The substance is classified for acute oral toxicity Category 4; there are no data from a dermal study. There is

considered to be low hazard and a DNEL for acute systemic effects is not required. It is noted that the

substance is classified as corrosive and sensitizing; therefore the potential for dermal exposure will be limited through

the use of engineering controls and suitable protective equipment.

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium 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
Explanation for the modification of the dose descriptor starting point:

Substance is used as curing agent for the epoxy systems. When used, it is fully reacted with epoxy resin and forms stable polymeric matrix. There is no possible release of the substance after it is used. For this reason, no exposure of general population to the substance is expected.

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
DNEL related information
Explanation for the modification of the dose descriptor starting point:

Substance is used as curing agent for the epoxy systems. When used, it is fully reacted with epoxy resin and forms stable polymeric matrix. There is no possible release of the substance after it is used. For this reason, no exposure of general population to the substance is expected.

Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information
Explanation for the modification of the dose descriptor starting point:

The substance is classified Cat 4 for acute oral toxicity; there are no data from a dermal study. There is

considered to be low hazard and a DNEL for acute systemic effects is not required. It is noted that the

substance is classified as corrosive.

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral 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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population