Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 701-328-3 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 24
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route-to-route-extrapolation needed
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as a starting point.
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on dermal 90-day study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rats are used in the animal study.
- AF for other interspecies differences:
- 1
- Justification:
- Value provided by Epoxy Resin Industry
- AF for intraspecies differences:
- 3
- Justification:
- Value provided by Epoxy Resin Industry
- AF for the quality of the whole database:
- 1
- Justification:
- A guideline test with GLP principle is used for read-across.
- AF for remaining uncertainties:
- 1
- Justification:
- No other uncertainties needed to be considered.
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
- Value:
- 1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.7 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 6
- Dose descriptor:
- other: NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- local, rat
- AF for other interspecies differences:
- 3
- Justification:
- worker
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
There is no available toxicity data concerning test substance on human, though test substance is widely used in industry.
NOAEL (i.e.100mg/kg.bw/day) of repeated dose toxicity test is used to apply the DNEL of long-term exposure by dermal derivation. Furthermore, as the long-term DNEL is normally sufficient to ensure that these effects do not occur, and as a rule of thumb, there may be no peak exposure for human, the DNEL of acute effects for dermal is unnecessary. As the existing data show the test substance is not eye irritant, the DNEL of eye effect is unnecessary to be derived.
Since the most likely route is considered to be via dermal, a DNEL for inhalation/oral route is not being proposed. However, detailed data through dermal route is available. A GLP test (R. J. McGuirk and K. A. Johnson, 2007) following OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study) showed that exposure to non-occluded dermal doses of 0, 1, 10, or100 mg/kg/day of test substance for 13 weeks did not result in adverse clinical signs or mortality. There were no treatment-related changes in ophthalmologic observations, body weights, feed consumption or clinical pathology during the thirteen-week study. Treatment-related effects in low dose rats were limited to slight scaling at the dermal test site. The response was similar after 2 or 13 weeks.
Therefore, NOAEL of 100mg/kg/d is preferred to apply for the DNEL of long-term dermal toxicity.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route-to-route-extrapolation
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as a starting point.
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on dermal 90-day study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rats are used in the animal study.
- AF for other interspecies differences:
- 1
- Justification:
- Value provided by Epoxy Resin Industry
- AF for intraspecies differences:
- 5
- Justification:
- Value provided by Epoxy Resin Industry
- AF for the quality of the whole database:
- 1
- Justification:
- A guideline test with GLP principle is used for read-across.
- AF for remaining uncertainties:
- 1
- Justification:
- No other uncertainties needed to be considered.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 5
- Justification:
- general population
- AF for other interspecies differences:
- 1
- Justification:
- local effects
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The existing data indicated no eye hazard, but slight irritation was observed at high test concentration in animal tests. Therefore, anyone that use such chemical should avoid a direct contact to prevent irritation to human's skin, eyes and respiration system from test substance.
In addition, as the most likely route is considered to be via dermal, a DNEL for inhalation/oral route is also unnecessary to be derived. However, detailed data through dermal route is available. A GLP test (R. J. McGuirk and K. A. Johnson, 2007) following OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study) showed that there were no treatment-related changes in clinical or ophthalmologic observations, body weights, feed consumption or clinical pathology during the thirteen-week study. Treatment-related effects in low dose rats were limited to slight scaling at the dermal test site. Based upon the current animal data, NOAEL value of 100mg/kg/d far exceed consumer exposure levels is used to derive the DNEL of test substance on dermal toxicity for general population.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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