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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 616-017-7 | CAS number: 7377-08-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.67 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):
- 125
- Dose descriptor starting point:
- LOAEL
- Value:
- 68 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 83.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
According to QSAR (see separate IUCLID summary), the oral LOAEL was predicted as 68 mg/kg bw/day.
Modification of the dose descriptor occurs by applying the following correction factors to convert the relevant dose descriptor (in this case a LOAEL) into the correct starting point for DNEL calculation:
Correction factor for differences in bioavailability (ABS) for route-to route extrapolation = 0.5 (for an oral dose descriptor used to calculate an inhalation DNEL)
Correction factor for differences in respiratory volume = 0.38 m3/kg bw/ 8 h (for an oral dose descriptor from a rat study used to calculate an inhalation DNEL)
Correction factor for light activity at work = 0.67
Correction for differences between human and experimental exposure conditions = 1.4 (for an oral dose descriptor used to calculate an inhalation DNEL)
Therefore, for workers the LOAEC would be:
LOAEC = 68 * 1/0.38*0.5*0.67*1.4 = 83.9 mg/m3
- AF for dose response relationship:
- 10
- Justification:
- Since the LOAEL is QSAR-derived, the maximum AF of 10 is applied to convert the LOAEC to a NOAEC and should therefore account for the fact that a very shallow dose response curve is assumed as a worst case in the absence of actual test data.
- AF for differences in duration of exposure:
- 1
- Justification:
- Default for chronic studies (ECHA REACH Guidance)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling AF is needed because the final units are not mg/kg (ECHA REACH Guidance).
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (ECHA REACH Guidance)
- AF for intraspecies differences:
- 5
- Justification:
- Default for workers (ECHA REACH Guidance)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (ECHA REACH Guidance)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.19 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):
- 500
- Dose descriptor starting point:
- LOAEL
- Value:
- 68 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 95.2 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
According to QSAR (see separate IUCLID summary), the oral LOAEL was predicted as 68 mg/kg bw/day.
Modification of the dose descriptor occurs by applying the following correction factors to convert the relevant dose descriptor (in this case a LOAEL) into the correct starting point for DNEL calculation:
Correction factor for differences in bioavailability (ABS) for route-to route extrapolation = 1 (for an oral dose descriptor used to calculate a dermal DNEL)
Correction for differences between human and experimental exposure conditions = 1.4 (for an oral dose descriptor used to calculate a dermal DNEL)
Therefore, for workers the modified LOAEL would be:
LOAEL = 68 * 1*1.4 = 95.2 mg/kg bw/day
- AF for dose response relationship:
- 10
- Justification:
- Since the LOAEL is QSAR-derived, the maximum AF of 10 is applied to convert the LOAEL to a NOAEL and should therefore account for the fact that a very shallow dose response curve is assumed as a worst case in the absence of actual test data.
- AF for differences in duration of exposure:
- 1
- Justification:
- Default for chronic studies (ECHA REACH Guidance)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (ECHA REACH Guidance)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (ECHA REACH Guidance)
- AF for intraspecies differences:
- 5
- Justification:
- Default for workers (ECHA REACH Guidance)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (ECHA REACH Guidance)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
All industrial activities involving the use of 4-aminobenzoyl-b-alanine will take place under strict Good Manufacturing Practices (GMP).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.12 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):
- 250
- Dose descriptor starting point:
- LOAEL
- Value:
- 68 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 29.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
According to QSAR (see separate IUCLID summary), the oral LOAEL was predicted as 68 mg/kg bw/day.
Modification of the dose descriptor occurs by applying the following correction factors to convert the relevant dose descriptor (in this case a LOAEL) into the correct starting point for DNEL calculation:
Correction factor for differences in bioavailability (ABS) for route-to route extrapolation = 0.5 (for an oral dose descriptor used to calculate an inhalation DNEL)
Correction factor for differences in respiratory volume = 1.15 m3/kg bw/ 8 h (for an oral dose descriptor from a rat study used to calculate an inhalation DNEL)
Correction for differences between human and experimental exposure conditions = 1 (for an oral dose descriptor used to calculate an inhalation DNEL)
Therefore, for the general population the LOAEC would be:
LOAEC = 68 * 1/1.15*0.5*1 = 29.6 mg/m3
- AF for dose response relationship:
- 10
- Justification:
- Since the LOAEL is QSAR-derived, the maximum AF of 10 is applied to convert the LOAEC to a NOAEC and should therefore account for the fact that a very shallow dose response curve is assumed as a worst case in the absence of actual test data.
- AF for differences in duration of exposure:
- 1
- Justification:
- Default for chronic studies (ECHA REACH Guidance)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling AF is needed because the final units are not mg/kg (ECHA REACH Guidance).
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (ECHA REACH Guidance)
- AF for intraspecies differences:
- 10
- Justification:
- Default for the general population (ECHA REACH Guidance)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (ECHA REACH Guidance)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.07 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):
- 1 000
- Dose descriptor starting point:
- LOAEL
- Value:
- 68 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 68 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
According to QSAR (see separate IUCLID summary), the oral LOAEL was predicted as 68 mg/kg bw/day.
Modification of the dose descriptor occurs by applying the following correction factors to convert the relevant dose descriptor (in this case a LOAEL) into the correct starting point for DNEL calculation:
Correction factor for differences in bioavailability (ABS) for route-to route extrapolation = 1 (for an oral dose descriptor used to calculate a dermal DNEL)
Correction for differences between human and experimental exposure conditions = 1 (for an oral dose descriptor used to calculate a dermal DNEL)
Therefore, for the general population the modified LOAEL would be:
LOAEL = 68 * 1*1 = 68 mg/kg bw/day
- AF for dose response relationship:
- 10
- Justification:
- Since the LOAEL is QSAR-derived, the maximum AF of 10 is applied to convert the LOAEL to a NOAEL and should therefore account for the fact that a very shallow dose response curve is assumed as a worst case in the absence of actual test data.
- AF for differences in duration of exposure:
- 1
- Justification:
- Default for chronic studies (ECHA REACH Guidance)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (ECHA REACH Guidance)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (ECHA REACH Guidance)
- AF for intraspecies differences:
- 10
- Justification:
- Default for the general population (ECHA REACH Guidance)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (ECHA REACH Guidance)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.07 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):
- 1 000
- Dose descriptor starting point:
- LOAEL
- Value:
- 68 mg/kg bw/day
- AF for dose response relationship:
- 10
- Justification:
- Since the LOAEL is QSAR-derived, the maximum AF of 10 is applied to convert the LOAEL to a NOAEL and should therefore account for the fact that a very shallow dose response curve is assumed as a worst case in the absence of actual test data.
- AF for differences in duration of exposure:
- 1
- Justification:
- Default for chronic studies (ECHA REACH Guidance)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (ECHA REACH Guidance)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (ECHA REACH Guidance)
- AF for intraspecies differences:
- 10
- Justification:
- Default for the general population (ECHA REACH Guidance)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (ECHA REACH Guidance)
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
Exposure of 4-aminobenzoyl-b-alanine to the general population will be negligible as it is an intermediate substance used in the synthesis of pharmaceutical ingredients. The intake of the pharmaceutical by the general public is not covered by REACH legislation.
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.
