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EC number: 222-037-3 | CAS number: 3323-53-3
- 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
Carcinogenicity
Administrative data
Description of key information
No experimental data are available for carcinogenicity of AH-Salt.
A 2-year feeding study with adipic acid gave no evidence of increased
tumor incidences in rats (Horn et al, 1957; for details see section
Repeated dose toxicity).
Cell transformation
In vitro cell transformation tests with AH-salt (analytical purity 100%)
in cultured BALB 3T3 cells revealed no morphological transformation both
in the absence and presence of a rat liver metabolic activation system
(BASF AG, 1980, see section Genetic toxicity in vitro). The highest
concentration was not cytotoxic. The positive control substances, as
expected, caused statistically significant increased incidences of
morphologically transformed foci. The acceptance criteria for the
validity of the tests were fulfilled.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- Young albino rats (50 – 60 g) were fed basal diet containing adipic acid. Body weights, food consumption and general appearance condition were recorded weekly. Gross autopsy was performed on animals that died during the experiment. After 2 years, the surviving rats were weighed, sacrificed and examined for gross and microscopic pathology. Organ weights were determined and tissue of different organs was examined microscopically.
- GLP compliance:
- no
- Remarks:
- pre GLP-study
- Species:
- rat
- Strain:
- not specified
- Details on species / strain selection:
- common rodent species
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
young male and female albino rats
- Source: Carworth Farm
- Weight at study initiation: ca. 60 g (males); ca. 50 g (females)
- Housing: individually in cages with wire mesh floors
- Diet: ad libitum
- Water: ad libitum
No further data. - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- continuously in the diet
- Dose / conc.:
- 0.1 other: % in diet
- Remarks:
- males; approximately 50 - 100 mg/kg bw/d
- Dose / conc.:
- 1 other: % in diet
- Remarks:
- males and females; approximately 500 - 1000 mg/kg bw/d
- Dose / conc.:
- 3 other: % in diet
- Remarks:
- males; approximately 1500 - 3000 mg/kg bw/d
- Dose / conc.:
- 5 other: % in diet
- Remarks:
- males; approximately 2500 - 5000 mg/kg bw/d
- No. of animals per sex per dose:
- 20 males per group (control group; 0.1%, 1%, 3%, 5% dose groups);
10 females (control group);
19 females (1% dose group) - Control animals:
- yes, plain diet
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly observations were made of the general appearance and condition of each
animal
BODY WEIGHT: Yes
- Time schedule for examinations: at weekly intervals during the course of the study
FOOD CONSUMPTION: Yes
- Time schedule: at weekly intervals during the course of the study
FOOD EFFICIENCY: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
After 2 years on the respective diets, the surviving rats were weighed, sacrificed by a blow on the head, and examined for gross and microscopic pathology. The brain, thyroid, lungs, heart, liver, spleen, kidneys, adrenals, stomach, and testes of approximately half of each group of males were weighed. The kidneys, spleen, liver, and heart of each female were weighed. Microscopic examination of the following tissues were done on 4 representative number of animals of each group: thyroid, lungs, heart, liver, spleen, kidneys, adrenals, stomach, small intestine, large intestine, pancreas, bone marrow, testes or ovaries, and uterus. - Statistics:
- no
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Males: Throughout the study, the following clinical signs were observed among all groups, including controls: wheezing, blood-tinged crust about the noses and eyes, and body sores. The incidence of these findings did not appear to be significantly different among the groups although a lower incidence of signs indicative of respiratory infection and body sores occurrent in the 5% dose group.
Females: Clinical signs noted in control and test groups included blood-tinged crust about the eyes and noses, unthriftness, and body sores. - Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- Males: The percent survival for each test group was higher than for the control group.
Females: Mortality in the treated group was similar to control. One experimental rat and two control animals died during the final 6 months. - Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Males: There were no body weight differences throughout the 2-year period in rats treated with 0.1 or 1% adipic acid. During the rapid growth period, the weight gains of the 3.0 and 5.0% adipic acid groups were significantly less than the control groups. At the end of the study the body weight of males was reduced by 10% and more in the two highest exposure groups.
Females: There were no significant differences in body weight gains. - Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Males: There was slight, but consistent, reduction in food consumption at 5%.
Females: There were no significant differences in food consumption. - Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- Males: When the surviving males were sacrificed at the end of the study, there was no significant differences in organ weights.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Males: The incidence of lung pathology and tumor growth appeared to be equally distributed among all groups, including the controls.
Females: There were no pathologic findings. - Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Males: When the surviving males were sacrificed at the end of the study, there was no significant differences in microscopic examination.
Females: There were no pathologic findings. - Dose descriptor:
- NOAEL
- Effect level:
- 500 - 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Remarks on result:
- other: The actual dose received corresponds to 1 % in the diet and was calculated using the food consumption.
- Critical effects observed:
- not specified
- Executive summary:
Rats were fed either the basal laboratory diet, or the diet to which adipic acid was added. Groups of 20 males received diets containing the test substance at 0 (control), 0.1, 1, 3, and 5% in the diet; 10 and 20 females received the test substance at 0 (control) and 1% in the diet, respectively. After 2 years, surviving rats were killed and examined grossly. The weights of selected organs were recorded, and microscopic examination of selected tissues was done on a representative numberof animals from each group.
Male rats: The percent survival for each test group was higher than for thecontrol group. There were no body weight differences throughout the 2-year period in rats treated with 0.1 or 1% adipic acid. During the rapid growth period, the weight gains of the 3.0 and 5.0% adipic acid groups were significantly less than the control groups. At the end of the study the body weight of males was reduced by 10% and more in the twohighest exposure groups. There was slight, but consistent, reduction in food consumption at 5%, Throughout the study, clinical signs were observed among all groups including controls. The incidence of these findings did not appear to be significantly different among the groups although a lower incidence of signs indicative of respiratory infection and body sores occurred in the 5% dose group. The incidence of lung pathology and tumor growth appeared to be equally distributed among all groups, including the controls. When the surviving males were sacrificed at the end of the study, there was no significant differences in organ weights or microscopic examination.
Female rats: There were no significant differences in body weight gains or food consumption. Clinical signs were noted in the control and the test group.There was no microscopic pathology.The NOAEL was 1% in the diet (ca. 500 - 1000 mg/kg bw/d).
Reference
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
There is no need to classify AH-Salt for carcinogenicity according to the Directive 67/548/EC or GHS or EU GHS criteria (Regulation (EC) N° 1907/2006).
Additional information
No experimental data considering carcinogenic activity are available for AH salt. However, the substance was not genotoxic in several in vitro and in vivo test systems and did not induce morphological transformation in cultured mammalian cells in the presence and absence of metabolic activation. In addition, a 2-year feeding study with one of the components of AH salt, adipic acid, gave no evidence of a carcinogenic activity, and both components of AH-salt, adipic acid and 1,6-diaminohexane, gave negative results in genotoxicity tests. Overall, the data available do not imply an increased risk of carcinogenic activity of AH salt. Therefore, a carcinogenic activity of AH salt has not to be considered probable, and additional testing of AH salt has not to be regarded necessary.
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