Registration Dossier
Registration Dossier
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EC number: 202-592-8 | CAS number: 97-59-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 284 mg/kg bw/day
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 2.5
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 710 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- The oral route of exposure is considered to be a conservative route of exposure as compared to dermal.
- AF for differences in duration of exposure:
- 1
- Justification:
- Chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF’s = 1 (Allometric scaling. Normally 4 for rat to human but this is an endogenous compound in both species and the reference toxicity value is a NOEL not a NOAEL).
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 1
- Justification:
- AF’s = 1 for Intraspecies differences workers. Normally this AF = 5 but this is an endogenous compound which is considered safe at single oral doses of 10 grams in both healthy and unhealthy patients and has been used safely in skin preparations for many years at concentrations of up to 2% by weight.
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- no hazard identified
Additional information - workers
The long-term DNEL’s are based on the NOEL for the 2 year oral study in Fischer 344 rats. Body weight information is not available but chronic body weight for the male Fischer 344 rats has been estimated by the USEPA as 380 grams. The males consumed 40 grams of Allantoin during the 106 week study period. This equates to a NOEL of 142 mg/kg bw/d.
DNEL dermal long term workers:
Oral NOAEL 142 mg x 20% worst case measured skin absorption = 142 x 5 = 710 mg/kg bw d
AF’s = 1 (Allometric scaling. Normally 4 for rat to human but this is an endogenous compound in both species and the reference toxicity value is a NOEL not a NOAEL) x 2.5 (Remaining interspecies differences) x 1 (Intraspecies differences workers. Normally 5 but again this is an endogenous compound which is considered safe at single oral doses of 10 grams in both healthy and unhealthy patients and has been used safely in skin preparations for many years at concentrations of up to 2% by weight) x 1 (chronic study) x 1 (DR reliability) x 1 (Quality of the database) = 2.5
DNEL Dermal long term workers = 710/2.5 = 284 mg/kg bw d
General Population - Hazard via inhalation route
Systemic 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
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:
- 284 mg/kg bw/day
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 2.5
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 710 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- Chronic 2 yr study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF’s = 1 (Allometric scaling. Normally 4 for rat to human but this is an endogenous compound in both species and the reference toxicity value is a NOEL not a NOAEL).
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 1
- Justification:
- AF’s = 1 for Intraspecies differences workers. Normally this AF = 5 but this is an endogenous compound which is considered safe at single oral doses of 10 grams in both healthy and unhealthy patients and has been used safely in skin preparations for many years at concentrations of up to 2% by weight.
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 56.8 mg/kg bw/day
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 2.5
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 142 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- Chronic 2 yr study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF’s = 1 (Allometric scaling. Normally 4 for rat to human but this is an endogenous compound in both species and the reference toxicity value is a NOEL not a NOAEL).
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 1
- Justification:
- AF’s = 1 for Intraspecies differences workers. Normally this AF = 5 but this is an endogenous compound which is considered safe at single oral doses of 10 grams in both healthy and unhealthy patients and has been used safely in skin preparations for many years at concentrations of up to 2% by weight.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The long-term DNEL’s are based on the NOEL for the 2 year oral study in Fischer 344 rats. Body weight information is not available but chronic body weight for the male Fischer 344 rats has been estimated by the USEPA as 380 grams. The males consumed 40 grams of Allantoin during the 106 week study period. This equates to a NOEL of 142 mg/kg bw d.
DNEL dermal long term general population:
Oral NOAEL 142 mg/kg bw d x 20% worst case measured skin absorption = 142 x 5 = 710 mg/kg bw d
AF’s = 1 (Allometric scaling. Normally 4 for rat to human but this is an endogenous compound in both species and the reference toxicity value is a NOEL not a NOAEL) x 2.5 (Remaining interspecies differences) x 1 (Intraspecies differences general population. Normally 10 but again this is an endogenous compound which is considered safe at single oral doses of 10 grams in both healthy and unhealthy patients and has been used safely in skin preparations for many years at concentrations of up to 2% by weight) x 1 (chronic study) x 1 (DR reliability) x 1 (Quality of the database) = 2.5
DNEL Dermal long term general population = 710/2.5 = 284 mg/kg bw d
DNEL Oral long term general population:
Oral NOAEL 142 mg/kg bw d
AF’s = 1 (Allometric scaling. Normally 4 for rat to human but this is an endogenous compound in both species and the reference toxicity value is a NOEL not a NOAEL) x 2.5 (Remaining interspecies differences) x 1 (Intraspecies differences general population. Normally 10 but again this is an endogenous compound which is considered safe at single oral doses of 10 grams in both healthy and unhealthy patients and has been used safely in skin preparations for many years at concentrations of up to 2% by weight) x 1 (chronic study) x 1 (DR reliability) x 1 (Quality of the database) = 2.5
DNEL oral long term general population = 142/2.5 = 56.8 mg/kg bw d
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