Registration Dossier
Registration Dossier
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EC number: 260-906-9 | CAS number: 57693-14-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 24.5 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):
- 72
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No study with inhalation exposure available
- AF for dose response relationship:
- 1
- Justification:
- Default factor proposed by ECHA
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor proposed by ECHA; Extrapolation from subacute to chornic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric rat-human factor proposed by ECHA
- AF for other interspecies differences:
- 1
- Justification:
- According to ECETOC technical Report 110 remaining differences are inclosed in the allometric extrapolation
- AF for intraspecies differences:
- 3
- Justification:
- Default factor proposed by ECETOC
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor proposed by ECHA
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor proposed by ECHA
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 24.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA & ECETOC Tech. Report 110
- Overall assessment factor (AF):
- 12
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 26 447 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No study with inhalation exposure available.
- AF for dose response relationship:
- 1
- Justification:
- Default factor proposed by ECHA
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric rat-human factor proposed by ECHA
- AF for other interspecies differences:
- 1
- Justification:
- According to ECETOC technical Report 110 remaining differences are inclosed in allometric extrapolation
- AF for intraspecies differences:
- 3
- Justification:
- Default factor proposed by ECETOC
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor proposed by ECHA
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor proposed by ECHA
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 27.78 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA & ECETOC
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The test item has a very polar chemical structure and a high molecular weight. As a worst case 50 % absorption through skin were assumed.
- AF for dose response relationship:
- 1
- Justification:
- Default factor proposed by ECHA
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor proposed by ECHA; extrapolation from subacute data
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor proposed by ECHA
- AF for other interspecies differences:
- 1
- Justification:
- According to ECETOC technical Report 110 remaining differences are inclosed in the allometric extrapolation
- AF for intraspecies differences:
- 3
- Justification:
- Default factor proposed by ECETOC
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor proposed by ECHA
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor proposed by ECHA
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
The test item did not show systemic adverse effects in any of the available acute and repeated dose studies in rats. Adverse effects were seen in the form local irritation on the eyes and in skin sensitisation. Skin sensitisation was assumed to be the most sensitive endpoint and protection against skin sensitisation will also protect against other possible effects.
In the workplace technical maesures to minimize exposure and standard hygenic measures as goggles, suitable gloves and longsleeved working cloths are mandatory. Skin contact as well as inhalation are reduced to a technically feasible minimum.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14.7 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA & ECETOC
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No study with inhalation exposure available
- AF for dose response relationship:
- 1
- Justification:
- Default factor proposed by ECHA
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor proposed by ECHA
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor proposed by ECHA
- AF for other interspecies differences:
- 1
- Justification:
- Remaining differences are inclosed in the allometric extrapolation
- AF for intraspecies differences:
- 5
- Justification:
- Default factor proposed by ECETOC
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor proposed by ECHA
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor proposed by ECHA
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 16.7 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA % ECETOC Technical Report 110
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There is no study employing dermal repeated application available. As the test item is a very polar chemical of high molecular weight an absorption rate of 50 % was assumed as a worst case assumption.
- AF for dose response relationship:
- 1
- Justification:
- Default factor proposed by ECHA
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor proposed by ECHA
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric rat-human allometric scaling factor proposed by ECHA
- AF for other interspecies differences:
- 1
- Justification:
- According to ECETOC technical Report 110 remaining differences are inclosed in the allometric extrapolation
- AF for intraspecies differences:
- 5
- Justification:
- Default factor proposed by ECETOC as more conservative than ECHA
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor proposed by ECHA
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor proposed by ECHA
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- DNEL (Derived No Effect Level)
- Value:
- 8.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA and ECETOC Technical report 110
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
n.a.
- AF for dose response relationship:
- 1
- Justification:
- Default factor proposed by ECHA
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor proposed by ECHA
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default rat-human allometric scaling factor proposed by ECHA
- AF for other interspecies differences:
- 1
- Justification:
- According to ECETOC technical Report 110 remaining differences are inclosed in the allometric extrapolation
- AF for intraspecies differences:
- 5
- Justification:
- Default factor proposed by ECETOC
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor proposed by ECHA
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor proposed by ECHA
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL extrapolated from long term DNEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
The test item did not show systemic adverse effects in any of the available acute and repeated dose studies in rats. Adverse effects were seen in the form of local irritation on the eyes and in skin sensitisation.
Skin sensitisation was assumed to be the most critical endpoint and protection against skin sensitisation will also protect against all other possible effects.
The product is sold to the general population exclusively in closed packaging, that is not opened during use, or bound to a matrix in textile, leather, plastic or other articles. No relevant exposure of the general population is expected.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
