Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 280-084-5 | CAS number: 82985-35-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 32.91 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2 468.42 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAECcorr = NOAELoral*(1/0.38 m³/kg bw/day)*(ABSoralrat/ABSinhhuman)*(6.7 m³ (8h)/10 m³ (8h)) * (7 days expsoure rat/5days exposure worker) = 1000 mg/kg bw/day*(1/0.38 m³/kg bw/day)*(1/1)*0.67*1.4 = 2468.42 mg/m³. In contrast to the recommendations of the ECHA Guidance, a factor of 1 (equal absorption of 100% assumed for the oral and the inhalative route for animals and humans) was included for the extrapolation from oral to inhalation absorption, as there is no valid data suggesting that inhalation leads to higher absorption than oral ingestion (recommendation of the VCI Working group "Toxicology", 2008). Molecules with a molecular weight <500 and a log Kow between 0 and 4 can be assumed to be well absorbed equivalently by the oral and inhalation route. Oral absorption may be reduced for acids and bases depending on their pKa value and their electric charge in the GI tract. More lipophilic substances may be better absorbed in the GI tract due to solubilisation with bile acids, and thus oral absorption may be higher than inhalation absorption (VCI Working group "Toxicology", 2008). Unless valid data suggest that inhalation leads to higher absorption than oral ingestion, equal absorption will be assumed when extrapolating from oral to inhalation route: ABSoralrat = oral absorption rate in rats, ABSinhhuman = inhalation absorption rate in humans.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- The DNEL is based on a subacute study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for workers
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL is based on a high quality study
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- 4.67 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 84 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 1000 mg/kg bw/day obtained for systemic toxicity after oral application in the subacute OECD 407 study with the registered substance was considered to be the most suitable dose descriptor for systemic toxicity. The dermal systemic DNEL after repeated exposure will therefore be derived from the oral NOAEL of 1000 mg/kg bw/day on the basis of route to route extrapolation.
Dermal NOAEL = oral NOAEL*ABS(oral)/ABS(dermal) * (7 days exposure rat/5 days exposure worker) = 1000 mg/kg bw/day *(1/1) * 1.4 = 1400 mg/kg bw/day. It is assumed that oral and dermal absorption rates are equal
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- The DNEL is based on a subacute study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for workers
- AF for the quality of the whole database:
- 1
- Justification:
- The DNEL is absed on a high quality study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
For assessment of long-term effects of bis(trimethoxysilylpropyl)amine an OECD 407 (subacute oral toxicity; Chemical Evaluation and Research Institute, Japan, 2014) is available with the submission substance.
In the repeated dose oral gavage study (conducted according to OECD 407 and in compliance with GLP) male and female Crl:CD(SD) rats were treated with 100, 300, and 1000 mg/kg bw/day with the test substance. Taken together, as no adverse effects were observed with respect to general/detailed clinical observations, haematological/clinical chemistry/neurobehaviour examination, body weights, organ measurements or urinalysis, the NOAEL (systemic) was considered to be 1000 mg/kg bw/day. Gross and histopathological examinations revealed edema (submucosal layer), slight hyperplasia of the surface epithelial cells (fundic mucosa) and slight necrosis (pyloric mucosa) in 1/5 males of the 1000 mg/kg bw/day group. In the recovery group, slight hyperplasia of the surface of epithelial cells in the pyloric mucosa and slight focal necrosis of the fundic mucosa related to the macroscopic findings in the glandular stomach were also observed in 1/5 male animals of the 1000 mg/kg bw/day dose group. Slight hyperplasia of the surface epithelial cells in the pyloric mucosa in the glandular stomach was observed in 1/5 females of the 1000 mg/kg bw/day dose group. Additionally, these effects were also noted in 1/5 females of the 1000 mg/kg bw/day dose group of the recovery group. Since local adverse effects on gross pathology and histopathological examination following treatment with the test material at 1000 mg/kg bw/day were recorded in 1 male and female animal each a NOAEL (local) of 300 mg/kg bw/day was derived.
The NOAEL of 1000 mg/kg bw/day obtained for systemic toxicity after oral application in the OECD 407 study with the registered substance was considered to be the most suitable dose descriptor for systemic toxicity. The dermal systemic DNEL after repeated exposure was therefore derived from the oral NOAEL of 1000 mg/kg bw/day on the basis of route to route extrapolation.
Repeated-dose toxicity – systemic effects – inhalation route – worker:
The DNEL for systemic effects via inhalation is determined on the basis of route-to-route extrapolation from an oral OECD 407 toxicity study with the submission substance. In contrast to the recommendations of the ECHA Guidance, a factor of 1 (equal absorption of 100% assumed for the oral and the inhalative route for animals and humans) was included for the extrapolation from oral to inhalation absorption, as there is no valid data suggesting that inhalation leads to higher absorption than oral ingestion (recommendation of the VCI Working group "Toxicology", 2008). Molecules with a molecular weight <500 and a log Kow between 0 and 4 can be assumed to be well absorbed equivalently by the oral and inhalation route. Oral absorption may be reduced for acids and bases depending on their pKa value and their electric charge in the GI tract. More lipophilic substances may be better absorbed in the GI tract due to solubilisation with bile acids, and thus oral absorption may be higher than inhalation absorption (VCI Working group "Toxicology", 2008). Unless valid data suggest that inhalation leads to higher absorption than oral ingestion, equal absorption will be assumed when extrapolating from oral to inhalation route.
In this study a NOAEL of 1000 mg/kg bw was derived.
The following correction was made to the NOAEL:
No correction for relative absorption oral vs. inhalation: 1
Correction for respiratory volume (rat/worker): 0.38 m³/kg bw (8 h)
Correction for respiratory volume (worker, light physical activity): 6.7 m³/10 m³
Correction for exposure duration (7 days/exposure rat, 5 days exposure worker): 7/5
Therefore the corrected NOAEC for repeated-dose systemic effects via inhalation is:
1000 mg/kg bw/day×1/0.38 m³/kg bw×(6.7 m³/10 m³)×1.4= 2468.42 mg/m³/day
The following assessment factors were applied to the corrected NOAEC:
Exposure duration (subacute to chronic): 6 (default)
Interspecies differences (toxicodynamics): 2.5 (default)
Intraspecies differences (worker): 5 (default)
Total AF: 6×2.5×5=75
The overall DNEL (repeated-dose – systemic – inhalation - worker) is therefore:
2468.42 mg/m³/day/75=32.91 mg/m³/day.
Repeated-dose toxicity – systemic effects – dermal route – worker:
As no adverse systemic effects were observed in the dermal subacute toxicity study the DNEL for systemic effects via the dermal route is determined on the basis of the systemic NOAEL of 1000 mg/kg bw observed in the OECD 407 oral toxicity study (repeated dose, subacute). The following correction was made to the NOAEL:
No correction for relative absorption oral vs. dermal: 1 (default)
Correction for exposure duration (7 days exposure rats, 5 days exposure workers): 7/5
Therefore the corrected NOAEL for repeated-dose systemic effects via the dermal route is:
1000 mg/kg bw/day×1×1.4=1400 mg/kg bw/day
The following assessment factors were applied to the systemic NOAEL:
Exposure duration (subacute to chronic): 6 (default)
Interspecies differences (toxicodynamics): 2.5 (default)
Interspecies differences (toxicokinetics, rat/human): 4 (default)
Intraspecies differences (worker): 5 (default)
Total AF: 6×2.5×4×5=300
The overall DNEL (repeated-dose – systemic – dermal - worker) is therefore:
1400 mg/kg bw/day/300=4.67 mg/kg bw/day.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.8 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 869.57 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAECcorr = NOAELoral*(1/1.15 m³/kg bw/day)*(ABSoralrat/ABSinhhuman = 1000 mg/kg bw/day* (1/1.15 m³/kg bw/day) = 869.57 mg/m³. In contrast to the recommendations of the ECHA Guidance, a factor of 1 (equal absorption of 100% assumed for the oral and the inhalative route for animals and humans) was included for the extrapolation from oral to inhalation absorption, as there is no valid data suggesting that inhalation leads to higher absorption than oral ingestion (recommendation of the VCI Working group "Toxicology", 2008). Molecules with a molecular weight <500 and a log Kow between 0 and 4 can be assumed to be well absorbed equivalently by the oral and inhalation route. Oral absorption may be reduced for acids and bases depending on their pKa value and their electric charge in the GI tract. More lipophilic substances may be better absorbed in the GI tract due to solubilisation with bile acids, and thus oral absorption may be higher than inhalation absorption (VCI Working group "Toxicology", 2008). Unless valid data suggest that inhalation leads to higher absorption than oral ingestion, equal absorption will be assumed when extrapolating from oral to inhalation route: ABSoralrat = oral absorption rate in rats, ABSinhhuman = inhalation absorption rate in humans.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- The DNEL is based on a subacute study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL is based on a high quality study
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- 1.67 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 84 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 1000 mg/kg bw/day obtained for systemic toxicity after oral application in the OECD 407 study with the registered substance was considered to be the most suitable dose descriptor for systemic toxicity. The dermal systemic DNEL after repeated exposure was therefore derived from the oral NOAEL of 1000 mg/kg bw/day on the basis of route to route extrapolation.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- The DNEL is based on a subacute study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF
- AF for other interspecies differences:
- 2.5
- Justification:
- Dafault AF
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL is based on a high quality study
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOAECcorr = NOAELoral*(ABSoralrat/ABSoralhuman) = 1000 mg/kg bw/day*(1/1) = 1000 mg/kg bw/day.It is assumed that oral absorption rate in rats and human is 100%. ABSoralrat = ABSoralhuman.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- The DNEL is based on a subacute study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL is based on a high quality study
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
For assessment of long-term effects of bis(trimethoxysilylpropyl)amine an OECD 407 (subacute oral toxicity; Chemical Evaluation and Research Institute, Japan, 2014) is available with the submission substance.
In the repeated dose oral gavage study (conducted according to OECD 407 and in compliance with GLP) male and female Crl:CD(SD) rats were treated with 100, 300, and 1000 mg/kg bw/day with the test substance. Taken together, as no adverse effects were observed with respect to general/detailed clinical observations, haematological/clinical chemistry/neurobehaviour examination, body weights, organ measurements or urinalysis, the NOAEL (systemic) was considered to be 1000 mg/kg bw/day. Gross and histopathological examinations revealed edema (submucosal layer), slight hyperplasia of the surface epithelial cells (fundic mucosa) and slight necrosis (pyloric mucosa) in 1/5 males of the 1000 mg/kg bw/day group. In the recovery group, slight hyperplasia of the surface of epithelial cells in the pyloric mucosa and slight focal necrosis of the fundic mucosa related to the macroscopic findings in the glandular stomach were also observed in 1/5 male animals of the 1000 mg/kg bw/day dose group. Slight hyperplasia of the surface epithelial cells in the pyloric mucosa in the glandular stomach was observed in 1/5 females of the 1000 mg/kg bw/day dose group. Additionally, these effects were also noted in 1/5 females of the 1000 mg/kg bw/day dose group of the recovery group. Since local adverse effects on gross pathology and histopathological examination following treatment with the test material at 1000 mg/kg bw/day were recorded in 1 male and female animal each a NOAEL (local) of 300 mg/kg bw/day was derived.
The NOAEL of 1000 mg/kg bw/day obtained for systemic toxicity after oral application in the OECD 407 study with the registered substance was considered to be the most suitable dose descriptor for systemic toxicity. The dermal systemic DNEL after repeated exposure was therefore derived from the oral NOAEL of 1000 mg/kg bw/day on the basis of route to route extrapolation.
Repeated-dose toxicity – systemic effects – inhalation route – general population:
The DNEL for systemic effects via inhalation is determined on the basis of route-to-route extrapolation from an oral OECD 407 toxicity study with the submission substance. In contrast to the recommendations of the ECHA Guidance, a factor of 1 (equal absorption of 100% assumed for the oral and the inhalative route for animals and humans) was included for the extrapolation from oral to inhalation absorption, as there is no valid data suggesting that inhalation leads to higher absorption than oral ingestion (recommendation of the VCI Working group "Toxicology", 2008). Molecules with a molecular weight <500 and a log Kow between 0 and 4 can be assumed to be well absorbed equivalently by the oral and inhalation route. Oral absorption may be reduced for acids and bases depending on their pKa value and their electric charge in the GI tract. More lipophilic substances may be better absorbed in the GI tract due to solubilisation with bile acids, and thus oral absorption may be higher than inhalation absorption (VCI Working group "Toxicology", 2008). Unless valid data suggest that inhalation leads to higher absorption than oral ingestion, equal absorption will be assumed when extrapolating from oral to inhalation route.
In this study a NOAEL of 1000 mg/kg bw was derived.
The following correction was made to the NOAEL:
No correction for relative absorption oral vs. inhalation: 1
Correction for respiratory volume (rat/general population): 1.15 m³/kg bw (24 h)
Therefore the corrected NOAEC for repeated-dose systemic effects via inhalation is:
1000 mg/kg bw/day/1.15 m³/kg bw = 869.57 mg/m³/day
The following assessment factors were applied to the corrected NOAEC:
Exposure duration (subacute to chronic): 6 (default)
Interspecies differences (toxicodynamics): 2.5 (default)
Intraspecies differences (general population): 10 (default)
Total AF: 6×2.5×10=150
The overall DNEL (repeated-dose – systemic – inhalation - worker) is therefore:
869.57 mg/m3/day/150=5.80 mg/m³/day.
Repeated-dose toxicity – systemic effects – dermal route – general population:
As no adverse systemic effects were observed in the dermal subacute toxicity study the DNEL for systemic effects via the dermal route is determined on the basis of the systemic NOAEL of 1000 mg/kg bw observed in the OECD 407 oral toxicity study (repeated dose, subacute). The following correction was made to the NOAEL:
No correction for relative absorption oral vs. dermal: 1 (default)
Therefore the corrected NOAEL for repeated-dose systemic effects via the dermal route is:
1000 mg/kg bw/day×1=1000 mg/kg bw/day
The following assessment factors were applied to the systemic NOAEL:
Exposure duration (subacute to chronic): 6 (default)
Interspecies differences (toxicodynamics): 2.5 (default)
Interspecies differences (toxicokinetics, rat/human): 4 (default)
Intraspecies differences (general population): 10 (default)
Total AF: 6×2.5×4×10=600
The overall DNEL (repeated-dose – systemic – dermal - worker) is therefore:
1000 mg/kg bw/day/600=1.67 mg/kg bw/day.
Repeated-dose toxicity – systemic effects – oral route – general population:
The DNEL for systemic effects via the oral route is determined on the basis an oral OECD 407 toxicity study (repeated dose, subacute) with the registered substance. In this study a NOAEL of 1000 mg/kg bw was derived.
No correction for relative absorption oral vs. oral: 1 (default)
Therefore the corrected NOAEL for repeated-dose systemic effects via the oral route is:
1000 mg/kg bw/day×1=1000 mg/kg bw/day
The following assessment factors were applied to the NOAEL:
Exposure duration (subacute to chronic): 6 (default)
Interspecies differences (toxicodynamics): 2.5 (default)
Interspecies differences (toxicokinetics, rat/human): 4 (default)
Intraspecies differences (general population): 10 (default)
Total AF: 6×2.5×4×10=600
The overall DNEL (repeated-dose – systemic – oral - general population) is therefore:
1000 mg/kg bw/day/600=1.67 mg/kg bw/day.
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.