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Diss Factsheets
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EC number: 231-293-5 | CAS number: 7486-38-6
- 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:
- 264 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):
- 5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 321 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- There is no dermal repeated dose toxicity study available. There is no reliable repeated inhalation toxicity study with histopathological examination of the nose available. In a 2-year oral study adipic acid was of low repeated dose toxicity, The NOAEL was 1% for female and male rats (approx. 750 mg/kg bw/day). Females were not dosed at higher concentrations, males dosed at higher concentrations (3 and 5%) caused body weight retardation with no indication of specific target organ toxicity (Horn et al. 1957).
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic studies available
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- taken into account for NOAEC derivation
- AF for other interspecies differences:
- 1
- Justification:
- No additional assessment factor necessary due to the database covering experiments in animal species and humans; no symptoms were reported after oral administration of up to 7 g of adipic acid per day, for 10 days to human volunteers (Weitzel, 1942 and 1947).
- AF for intraspecies differences:
- 5
- Justification:
- default factor worker
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 38 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):
- 20
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic studies available
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat -> humans
- AF for other interspecies differences:
- 1
- Justification:
- No additional assessment factor necessary due to the database covering experiments in animal species and humans; no symptoms were reported after oral administration of up to 7 g of adipic acid per day, for 10 days to human volunteers (Weitzel, 1942 and 1947).
- AF for intraspecies differences:
- 5
- Justification:
- default for worker
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- no hazard identified
Additional information - workers
Local toxicity:
Disodium adipate is no irritating to the skin or eyes.
Systemic toxicity:
Overall, the systemic toxicity of disodium adipate is low; it is not sensitizing, not mutagen, not toxic to reproductive organs and fertility, not a developmental toxicant and not carcinogenic. The DNEL calculations are based on adipic acid data.
Starting point:
There is no dermal repeated dose toxicity study available. There is no reliable repeated inhalation toxicity study with histopathological examination of the nose available. In a 2-year oral study adipic acid was of low repeated dose toxicity, The NOAEL was 1% for female and male rats (approx. 750 mg/kg bw/day). Females were not dosed at higher concentrations, males dosed at higher concentrations (3 and 5%) caused body weight retardation with no indication of specific target organ toxicity (Horn et al. 1957).
Systemic toxicity by inhalation:
A) Modification of starting point and route to route extrapolation (oral route to inhalation):
Taking into account the following factors:
- The default physiological parameter under allometric scaling principle in REACH guidance documentation for worker (8h): 1/0.38 m3/kg/day
- Default factor for worker “light activity” 6.7m3/10m3 = 0.67
- differences in absorption oral/inhalation = 1( toxicokinetic data indicate that adipic acid is well absorbed by the oral route)
The overall corrected systemic NOAEC for worker is 1321.5 mg/m3
B) Assessment factors:
- Allometric scaling (AS) factor not applied according to REACH guidance documentation chapter R. 8, table R. 8-4; page 32. (Already considered in step A)
- Remaining interspecies differences: 1 ( No additional assessment factor necessary due to the database covering experiments in animal species and humans; no symptoms were reported after oral administration of up to 7 g of adipic acid per day, for 10 days to human volunteers (Weitzel, 1942 and 1947).
- Intraspecies differences: 5 (default factor worker according to REACH guidance documentation chapter R. 8)
Systemic long- and short-term inhalation DNEL (worker) = 1321.5 mg/m3 / 5 = 264 mg/m3
Systemic toxicity by oral or dermal route:
A) No modification of the starting point is necessary; corrected NOAEL 750 mg/kg/day. We used the REACH guidance documentation chapter R8 default
assumption that oral absorbtion is equal to dermal absorbtion.B)
- Assessment factors see above; including allometric scaling from rat to humans (4) and intraspecies differences for workers (5)
Systemic long-term oral/dermal DNELs (worker) = 750 mg/kg / 20 = 38 mg/kg/day
According to REACH TGD dermal and oral ‘short-term’ exposures should normally be assessed using the long-term DNEL and application of an additional factor. Since adipic acid is of low systemic toxicity and only slightly issitating to the skin an additional factor of 2 is applied to calculate short term DNEL.
Systemic short-term oral/dermal DNELs (worker) = 750 mg/m3 / 20 = 38 mg/kg/day
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 65 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):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 652.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- There is no dermal repeated dose toxicity study available. There is no reliable repeated inhalation toxicity study with histopathological examination of the nose available. In a 2-year oral study adipic acid was of low repeated dose toxicity, The NOAEL was 1% for female and male rats (approx. 750 mg/kg bw/day). Females were not dosed at higher concentrations, males dosed at higher concentrations (3 and 5%) caused body weight retardation with no indication of specific target organ toxicity (Horn et al. 1957)
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic studies available
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- taken into account for NOAEC calculation
- AF for other interspecies differences:
- 1
- Justification:
- No additional assessment factor necessary due to the database covering experiments in animal species and humans; no symptoms were reported after oral administration of up to 7 g of adipic acid per day, for 10 days to human volunteers (Weitzel, 1942 and 1947).
- AF for intraspecies differences:
- 10
- Justification:
- default
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 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):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- oral absorption assumed to be equal to dermal absorption as a conservative approach.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic studies available
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats -> humans
- AF for other interspecies differences:
- 1
- Justification:
- No additional assessment factor necessary due to the database covering experiments in animal species and humans; no symptoms were reported after oral administration of up to 7 g of adipic acid per day, for 10 days to human volunteers (Weitzel, 1942 and 1947).
- AF for intraspecies differences:
- 10
- Justification:
- default
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 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):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic studies available
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats -> humans
- AF for other interspecies differences:
- 1
- Justification:
- No additional assessment factor necessary due to the database covering experiments in animal species and humans; no symptoms were reported after oral administration of up to 7 g of adipic acid per day, for 10 days to human volunteers (Weitzel, 1942 and 1947).
- AF for intraspecies differences:
- 10
- Justification:
- default
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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
Local toxicity:
Disodium adipate is not irritating to the skin or eyes.
Systemic toxicity:
Overall, the systemic toxicity of disodium adipate is low; it is not sensitizing, not mutagen, not toxic to reproductive organs and fertility, not a developmental toxicant and not carcinogenic. The DNEL calculations are based on adipic acid data.
Starting point:
There is no dermal repeated dose toxicity study available. There is no reliable repeated inhalation toxicity study with histopathological examination of the nose available. In a 2-year oral study adipic acid was of low repeated dose toxicity, The NOAEL was 1% for female and male rats (approx. 750 mg/kg bw/day). Females were not dosed at higher concentrations, males dosed at higher concentrations (3 and 5%) caused body weight retardation with no indication of specific target organ toxicity Horn et al. 1957).
Systemic toxicity by inhalation:
A) Modification of starting point:
Taking into account the following factors:
- The default physiological parameter under allometric scaling principle in REACH guidance documentation for the general population: 1/1.15 = 0.87 m3/kg/day
- Differences in absorption oral/inhalation = 1( toxicokinetic data indicate that adipic acid is well absorbed by the oral route)
The overall corrected systemic NOAEC for the general population: 652.5 mg/m3
B) Assessment factors:
- Allometric scaling (AS) factor not applied according to REACH guidance documentation chapter R. 8, table R. 8-4; page 32. (Already considered in step A)
- Remaining interspecies differences: 1 ( No additional assessment factor necessary due to the database covering experiments in animal species and humans; no symptoms were reported after oral administration of up to 7 g of adipic acid per day, for 10 days to human volunteers (Weitzel, 1942 and 1947).
- Intraspecies differences: 10 (default factor the general population according to REACH guidance documentation chapter R. 8)
Systemic long- and short-term inhalation DNEL (general population) = 1321.5 mg/m3 / 10 = 65 mg/m3
Systemic toxicity by oral or dermal route:
A) No modification of the starting point is necessary; corrected NOAEL 750 mg/kg/day mg/kg/day
B)
- Assessment factors see above; including allometric scaling from rat to humans: 4
- Intraspecies factor general population (REACH TGD default factor): 10
Systemic long- and short-term oral/dermal DNELs (general population) = 750 mg/kg / 40 = 19 mg/kg/day
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