Registration Dossier
Registration Dossier
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EC number: 432-070-7 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 22 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):
- 80
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 438 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- oral to inhalation
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for intraspecies differences:
- 5
- Justification:
- human to workers
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 111 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 3 500 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- oral to inhalative
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for intraspecies differences:
- 5
- Justification:
- human to worker
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:
- 6.3 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):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- oral to dermal
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for intraspecies differences:
- 5
- Justification:
- human to workers
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 100 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- same route
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for intraspecies differences:
- 5
- Justification:
- human to worker
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)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Derivation of DNEL for acute dermal systemic effects:
start value for assessment: NOAEL (rat, dermal, acute) = 2000 mg/kg, since LD50(rat, dermal, acute) > 2000 mg/kg
Uncertainties |
AF |
Justification |
route of exposure |
1 |
same route |
Interspecies differences |
4 |
rat to human |
Intraspecies differences |
5 |
human to worker |
Overall |
20 |
|
AFs according to ECETOC Technical Report No. 110
DNEL = NOAEL/ AF =
= 2000 mg/kg/day / 20 =
=100 mg/kg/day
DNEL (acute, dermal, systemic, worker) =100 mg/kg/day
Due to quality of the database further assessment factors are not required. Further it is acknowledged that for DNEL derivation from acute toxicity data no generally accepted methodology exists. Since in this case the LD50is actually a LD0, the abovementioned derivation is scientifically justified.
Derivation of DNEL for acute inhalative systemic effects:
start value for assessment: NOAEL (rat, oral, acute) = 2000 mg/kg, since LD50(rat, oral, acute) > 2000 mg/kg
Uncertainties |
AF |
Justification |
route of exposure |
2 |
oral to inhalative |
Interspecies differences |
4 |
rat to human |
Intraspecies differences |
5 |
human to worker |
Overall |
40 |
|
AFs according to ECETOC Technical Report No. 110
Calculation
of NAEC according to guideline R.8:
NAEC (human, inhalation, acute) = (2000 mg/kg∙70 kg) / (4∙10 m3)
= 3500 mg/m3
Calculation of DNEL (4 hours) by taking into account the remaining AFs:
3500 mg/m3/ 10 = 350 mg/m3
Correction for short term exposure (15 min) using modification of Haber's Law (ECHA guideline R.7a):
c = ((350 mg/m3)3∙(8.0 h / 0.25 h))1/3=1111 mg/m3
DNEL (acute, inhalation, systemic, worker) =1111 mg/m3
Due to quality of the database further assessment factors are not required. Further it is acknowledged that for DNEL derivation from acute toxicity data no generally accepted methodology exists. Since in this case the LD50is actually a LD0, the abovementioned derivation is scientifically justified.
Derivation of DNEL for long-term dermal systemic effects:
start value for assessment: NOAEL (rat, oral, sub-chronic) = 250 mg/kg
Uncertainties |
AF |
Justification |
route of exposure |
1 |
oral to dermal |
Interspecies differences |
4 |
rat to human |
Intraspecies differences |
5 |
human to workers |
Exposure duration |
2 |
sub-chronic to chronic |
Overall |
40 |
|
AFs according to ECETOC Technical Report No. 110
DNEL = NOAEL / AF =
= 250 mg/kg/day / 40 =
=6.3 mg/kg/day
DNEL (long-term, dermal, systemic, worker) =6.3 mg/kg/day
Derivation of DNEL for long-term inhalative systemic effects:
start value for assessment: NOAEL (rat, oral, sub-chronic) = 250 mg/kg
Uncertainties |
AF |
Justification |
route of exposure |
2 |
oral to inhalation |
Interspecies differences |
4 |
rat to human |
Intraspecies differences |
5 |
human to workers |
Exposure duration |
2 |
sub-chronic to chronic |
Overall |
80 |
|
AFs according to ECETOC Technical Report No. 110
Calculation of NAEC according to guideline R.8:
NAEC (human, inhalation, long-term) = (250 mg/kg·70 kg) / (4∙10 m3) = 438 mg/m3
Calculation of DNEL by taking into account the remaining AFs:
DNEL (long-term, inhalation, systemic, worker) = 438 mg/m3/ 20 =22 mg/m3
DN(M) ELs that could not be derived:
-DN(M) EL for acute/short term exposure -local effects, since there are no quantifiable starting points.
-DN(M) EL for long-term exposure -local effects, since there are no quantifiable starting points.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 16 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):
- 160
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 653 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- oral to inhalation
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for intraspecies differences:
- 10
- Justification:
- human to general population
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 828 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 80
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 5 224 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- oral to inhalative
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for intraspecies differences:
- 10
- Justification:
- human to general population
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:
- 3.1 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):
- 80
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- oral to dermal
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for intraspecies differences:
- 10
- Justification:
- human to general population
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 50 mg/kg bw/day
- Most sensitive endpoint:
- acute 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:
- 2 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- same route
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for intraspecies differences:
- 10
- Justification:
- human to general population
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)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.1 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):
- 80
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- same route
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for intraspecies differences:
- 10
- Justification:
- human to general population
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 50 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- same route
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for intraspecies differences:
- 10
- Justification:
- human to general population
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The substance is used as a reactant for the production of a polymer in an article (diaper) and the general population would have only potential exposure to the substance when using this article. A direct exposure of the general population with this substance as such or in its polymeric matrix is practically not possible.
Since a release of the substance from the article is not intended and the substance does not fulfil the criteria of Article 57 of the REACH Regulation, the exposure of the general population by an article does not need to be evaluated according to Article 7 of the REACH Regulation.
Derivation of DNEL for acute dermal systemic effects:
start value for assessment: NOAEL (rat, dermal, acute) = 2000 mg/kg, since LD50(rat, dermal, acute) > 2000 mg/kg
Uncertainties |
AF |
Justification |
route of exposure |
1 |
same route |
Interspecies differences |
4 |
rat to human |
Intraspecies differences |
10 |
human to general population |
Overall |
40 |
|
AFs according to ECETOC Technical Report No. 110
DNEL = NOAEL / AF =
= 2000mg/kg/day / 40 =
=50 mg/kg/day
DNEL (acute, dermal, systemic, general population) =50 mg/kg/day
Due to quality of the database further assessment factors are not required. Further it is acknowledged that for DNEL derivation from acute toxicity data no generally accepted methodology exists. Since in this case the LD50is actually a LD0, the abovementioned derivation is scientifically justified.
Derivation of DNEL for acute inhalative systemic effects:
start value for assessment: NOAEL (rat, oral, acute) = 2000 mg/kg, since LD50(rat, oral, acute) > 2000 mg/kg
Uncertainties |
AF |
Justification |
route of exposure |
2 |
oral to inhalative |
Interspecies differences |
4 |
rat to human |
Intraspecies differences |
10 |
human to general population |
Overall |
80 |
|
AFs according to ECETOC Technical Report No. 110
Calculation of
NAEC according to guideline R.8:
NAEC (human, inhalation, acute) = (2000 mg/kg∙70 kg) / (4∙6.7 m3)
= 5224 mg/m3
Calculation of DNEL (4 hours) by taking into account the remaining AFs:
5,224 mg/m3/ 20 = 261 mg/m3
Correction for short term exposure (15 min) using modification of Haber's Law (ECHA guideline R.7a):
c = ((261 mg/m3)3∙(8.0 h / 0.25 h))1/3=828 mg/m3
DNEL (acute, inhalation, systemic, general population) =828 mg/m3
Due to quality of the database further assessment factors are not required. Further it is acknowledged that for DNEL derivation from acute toxicity data no generally accepted methodology exists. Since in this case the LD50is actually a LD0, the abovementioned derivation is scientifically justified.
Derivation of DNEL for acute oral systemic effects:
start value for assessment: NOAEL (rat, oral, acute) = 2000 mg/kg, since LD50(rat, oral, acute) > 2000 mg/kg
Uncertainties |
AF |
Justification |
route of exposure |
1 |
same route |
Interspecies differences |
4 |
rat to human |
Intraspecies differences |
10 |
human to general population |
Overall |
40 |
|
AFs according to ECETOC Technical Report No. 110
DNEL = NOAEL / AF =
= 2000mg/kg/day / 40 =
=50 mg/kg/day
DNEL (acute,oral, systemic, general population) =50 mg/kg/day
Due to quality of the database further assessment factors are not required. Further it is acknowledged that for DNEL derivation from acute toxicity data no generally accepted methodology exists. Since in this case the LD50is actually a LD0, the abovementioned derivation is scientifically justified.
Derivation of DNEL for long-term dermal systemic effects:
start value for assessment: NOAEL (rat, oral, sub-chronic) = 250 mg/kg
Uncertainties |
AF |
Justification |
route of exposure |
1 |
oral to dermal |
Interspecies differences |
4 |
rat to human |
Intraspecies differences |
10 |
human to general population |
Exposure duration |
2 |
sub-chronic to chronic |
Overall |
80 |
|
AFs according to ECETOC Technical Report No. 110
DNEL = NOAEL / AF =
= 250 mg/kg/day / 80 =
=3.1 mg/kg/day
DNEL (long-term, dermal, systemic, general population) =3.1 mg/kg/day
Derivation of DNEL for long-term inhalative systemic effects:
start value for assessment: NOAEL (rat, oral, sub-chronic) = 250 mg/kg
Uncertainties |
AF |
Justification |
route of exposure |
2 |
oral to inhalation |
Interspecies differences |
4 |
rat to human |
Intraspecies differences |
10 |
human to general population |
Exposure duration |
2 |
sub-chronic to chronic |
Overall |
160 |
|
AFs according to ECETOC Technical Report No. 110
Calculation of NAEC according to guideline R.8:
NAEC (human, inhalation, long-term) = (250 mg/kg·70 kg) / (4∙6.7 m3) = 653 mg/m3
Calculation of DNEL by taking into account the remaining AFs:
DNEL (long-term, inhalation, systemic, general population) = 653 mg/m3/ 40 =16 mg/m3
DNEL (long-term, inhalation, systemic, general population) =16 mg/m3
Derivation of DNEL for long-term oral systemic effects:
start value for assessment: NOAEL (rat, oral, sub-chronic) = 250 mg/kg
Uncertainties |
AF |
Justification |
route of exposure |
1 |
same route |
Interspecies differences |
4 |
rat to human |
Intraspecies differences |
10 |
human to general population |
Exposure duration |
2 |
sub-chronic to chronic |
Overall |
80 |
|
AFs according to ECETOC Technical Report No. 110
DNEL = NOAEL / AF =
= 250 mg/kg/day / 80 =
=3.1 mg/kg/day
DNEL (long-term, inhalation, systemic, general population) =3.1 mg/kg/day
The following DN(M) EL could not be derived:
-DN(M) EL for acute/short term exposure -local effects, because no quantifiable starting points exist.
-DN(M) EL for long-term exposure -local effects, because no quantifiable starting points exist.
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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