Registration Dossier
Registration Dossier
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EC number: 308-072-8 | CAS number: 97862-28-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 156 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA and ERASM factors
- Overall assessment factor (AF):
- 10.2
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 587 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Key 90-day oral toxicity study available; no repeated dose inhalation toxicity study available.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 3.4
- Justification:
- ERASM extrapolation factor from subacute (starting point) to chronic (end point); see also justification attached.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is already applied in route-to-route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- ERASM default factor for other interspecies differences.
- AF for intraspecies differences:
- 3
- Justification:
- ERASM default factor for intraspecies differences.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 331 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA and ERASM factors
- Overall assessment factor (AF):
- 40.8
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 13 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- A key oral 90-day toxicity study is available; there was no repeated-dose dermal toxicity study.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 3.4
- Justification:
- ERASM extrapolation factor from subacute (starting point) to chronic (end point); see also justification attached.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- ERASM default factor for other interspecies differences.
- AF for intraspecies differences:
- 3
- Justification:
- ERASM default factor for intraspecies differences.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Following source data were used for DNEL calculation:
- Key data for subacute toxicity were available from an oral (gavage) OECD 422 study in rats with read-across substance 'Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts', at dose levels given by oral gavage of 100, 300 and 1000 mg/kg bw/day. No relevant effects were observed at 100 and 300 mg/kg bw. At the dose of 1000 mg/kg bw, decreased body weight, increased serum ALAT and decreased serum albumin, macroscopic and microscopic stomach changes were observed. NOAEL for systemic toxicity was 300 mg/kg bw/day.
- Key data for subchronic toxicity were available from an oral (diet) 90-day toxicity study in rats with read-across substance 'Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18unsaturated alkyl) tetrasodium salts' dosed at 0.5, 2 and 8 (reduced to 4) g/kg bw.day. The study showed decreased body weight gain, feed consumption and food efficiency at the mid dose and high dose levels and increased SGOT and SGPT (liver enzymes) at the high dose. Further hematuria was seen in the mid and high dose rats, various organ weights were decreased (e.g. decrease in adrenal and gonadal weight in high dose groups; decrease in pituitary weight in females of high dose group) and lower urinary tract pathology was seen in 2 high dosed rats. It thus appeared that the NOEL in the rat was below 0.50 g/kg/day, however 0.5g act.ingr./kg bw/day can be considered as NOAEL.
- Taking into account both studies, the NOAEL of 300 mg/kg bw can be considered as the most conservative NOAEL. A justification for calculation of DNELs is attached.
Qualitative
assessment
Only
systemic long term exposure values for worker and general population
were calculated, because no concrete values (like NOAEL, LOAEL etc) are
available from acute or irritation studies. The study design of the test
conducted assessing the acute and local toxicity does not allow in
general the derivation of local or acute DNELs, as most of the tests
were, for example, conducted as limit tests due to animal welfare.
Therefore a qualitative risk assessment for irritation is performed.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 46 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA and ERASM factors
- Overall assessment factor (AF):
- 17
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 783 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- A key oral 90-day toxicity study is available; there was no repeated-dose inhalation toxicity study.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 3.4
- Justification:
- ERASM extrapolation factor from subacute (starting point) to chronic (end point); see also justification attached..
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is already applied in route-to-route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- ERASM default factor for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- ERASM default factor for intraspecies differences.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
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:
- DNEL (Derived No Effect Level)
- Value:
- 199 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA and ERASM factors
- Overall assessment factor (AF):
- 68
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 13 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- A key oral 90-day toxicity study is available; there was no repeated-dose dermal toxicity study.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 3.4
- Justification:
- ERASM extrapolation factor from subacute (starting point) to chronic (end point); see also justification attached.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- ERASM default factor for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- ERASM default factor for intraspecies differences.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.41 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA and ERASM factors
- Overall assessment factor (AF):
- 68
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Not applicable
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 3.4
- Justification:
- ERASM extrapolation factor from subacute (starting point) to chronic (end point); see also justification attached.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- ERASM default factor for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- ERASM default factor for intraspecies differences.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
Following source data were used for DNEL calculation:
- Key data for subacute toxicity were available from an oral (gavage) OECD 422 study in rats with read-across substance 'Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts', at dose levels given by oral gavage of 100, 300 and 1000 mg/kg bw/day. No relevant effects were observed at 100 and 300 mg/kg bw. At the dose of 1000 mg/kg bw, decreased body weight, increased serum ALAT and decreased serum albumin, macroscopic and microscopic stomach changes were observed. NOAEL for systemic toxicity was 300 mg/kg bw/day.
- Key data for subchronic toxicity were available from an oral (diet) 90-day toxicity study in rats with read-across substance 'Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18unsaturated alkyl) tetrasodium salts' dosed at 0.5, 2 and 8 (reduced to 4) g/kg bw.day. The study showed decreased body weight gain, feed consumption and food efficiency at the mid dose and high dose levels and increased SGOT and SGPT (liver enzymes) at the high dose. Further hematuria was seen in the mid and high dose rats, various organ weights were decreased (e.g. decrease in adrenal and gonadal weight in high dose groups; decrease in pituitary weight in females of high dose group) and lower urinary tract pathology was seen in 2 high dosed rats. It thus appeared that the NOEL in the rat was below 0.50 g/kg/day, however 0.5g act.ingr./kg bw/day can be considered as NOAEL.
- Taking into account both studies, the NOAEL of 300 mg/kg bw can be considered as the most conservative NOAEL.A justification for calculation of DNELs is attached.
Qualitative
assessment
Only
systemic long term exposure values for worker and general population
were calculated, because no concrete values (like NOAEL, LOAEL etc) are
available from acute or irritation studies. The study design of the test
conducted assessing the acute and local toxicity does not allow in
general the derivation of local or acute DNELs, as most of the tests
were, for example, conducted as limit tests due to animal welfare.
Therefore a qualitative risk assessment for irritation is performed.
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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