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EC number: 282-199-6 | CAS number: 84144-79-6
Toxicological Summary
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
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