Registration Dossier
Registration Dossier
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EC number: 800-766-3 | CAS number: 1424148-97-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.3 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC Technical Report No. 110_Page 62
- Overall assessment factor (AF):
- 160
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 42 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Comparable resorption for oral and inhalation routes assumed; human body weight of 70 kg; respiration volume of 10 m3 for 8 working hours
- AF for dose response relationship:
- 2
- Justification:
- No NOAEL could be estalished and the LOAEL is used as the base for the DNEL derivation. The effect at LOAEL was limited to reduced spleen weight of fetuses, therefore the use of 2 as additional factor is considered to be appropriate.
- AF for differences in duration of exposure:
- 1
- Justification:
- The exposure duration covered the entire second and the third term of the pregnancy; in the supportng study (OECD 422), in which the treatment covered the entire pregnancy, no effect on numbers of corpora lutea and implantation sites was observed; no bioaccumulating property can be assigned for the registration substance.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The allometric scaling factor from rat is 4 according to ECHA REACH Guidance
- AF for other interspecies differences:
- 10
- Justification:
- According to the ECETOC Technical Report No. 110_Page 62
- AF for intraspecies differences:
- 1
- Justification:
- According to the ECETOC Technical Report No. 110_Page 62
- AF for the quality of the whole database:
- 1
- Justification:
- All data are Klimish 1 or 2
- AF for remaining uncertainties:
- 2
- Justification:
- For some endpoints read-across is used.
Acute/short term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Value:
- 0.3 mg/m³
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Value:
- 0.3 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Value:
- 0.3 mg/m³
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.04 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC Technical Report No. 110_Page 62
- Overall assessment factor (AF):
- 160
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 6 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Comparable resorption for oral and inhalation routes assumed; human body weight of 70 kg; respiration volume of 10 m3 for 8 working hours
- AF for dose response relationship:
- 2
- Justification:
- No NOAEL could be estalished and the LOAEL is used as the base for the DNEL derivation. The effect at LOAEL was limited to reduced spleen weight of fetuses, therefore the use of 2 as additional factor is considered to be appropriate.
- AF for differences in duration of exposure:
- 1
- Justification:
- The exposure duration covered the entire second and the third term of the pregnancy; in the supportng study (OECD 422), in which the treatment covered the entire pregnancy, no effect on numbers of corpora lutea and implantation sites was observed; no bioaccumulating property can be assigned for the registration substance.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The allometric scaling factor from rat is 4 according to ECHA REACH Guidance
- AF for other interspecies differences:
- 10
- Justification:
- According to ECETOC Technical Report No. 110_Page 62
- AF for intraspecies differences:
- 1
- Justification:
- According to ECETOC Technical Report No. 110_Page 62
- AF for the quality of the whole database:
- 1
- Justification:
- All data are Klinish 1 or 2
- AF for remaining uncertainties:
- 2
- Justification:
- Read-across is used for some endpoints
Acute/short term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Value:
- 0.04 mg/kg bw/day
DNEL related information
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:
- no hazard identified
Additional information - workers
Relevant chemical species for exposure- and risk assessment
The registration substance is a salt of a weak acid and is expected dissociate immediately when dissolved in aqueous system or in biological fluid. It should be mentioned here, that manufacture and use of the registration substance occurs only as dissolved in aqueous system. Therefore, the relevant chemical species for worker exposure is the corresponding acid. Accordingly, the exposure- and risk assessment should be performed for its acid form, (Pentapropenyl succinimido)-caproic acid.
It is apparent therefore, that the DNEL to be used for the risk assessment should be based on the dose of (Pentapropenyl succinimido)-caproic acid.
For that purpose, the LOAEL obtained in the provided key study should be extrapolated for its acid form.
For the LOAEL for the acid form the only factor to be considered is the molecular mass difference (420 g/mol vs ca. 530 g/mol). In the presented key study, the applied doses were 8, 40 and 200 mg/kg bw, corresponding to 6, 30 and 160 mg/kg bw for the acid form. For the DNEL derivation the dose levels of 6 mg/kg bw as LOAEL will be used.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
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)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
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)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Value:
- 1.5 µg/kg bw/day
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
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.
