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EC number: 915-318-3 | CAS number: -
- 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
Endpoint summary
Administrative data
Description of key information
Based on the results of this study, the no-observed-adverse-effect-level (NOAEL) for general toxicity was 10000 ppm in the male rats and was not established in the female rats. In the females, reductions in body weight gain or a body weight loss and reduced food consumption were observed at all doses during the premating and gestation phase. Reductions in mean body weights were observed at 5000 and 10000 ppm during the gestation phase and at 10000 ppm during the lactation phase.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- K1
Additional information
The objectives of this study were to test for toxic effects/disturbances resulting from repeated exposure to Crl:CD(SD) male and female rats to POLYAMBROL® in the diet beginning before cohabitation, through mating and continuing for 49 days (male rats) or through parturition until Lactation Day 13 (female rats). This study was designed to incorporate a reproduction/developmental toxicity screening test that is used to provide initial information on possible effects on male and female reproductive performance (e.g., gonadal function, mating behavior, conception, development of the conceptus and parturition). The study also places emphasis on neurological effects as a specific endpoint and identifies the neurotoxic potential of a test substance, which may warrant further in-depth investigation.
The study design was as follows:
Text Table 1
Experimental Design
Group No. | Test Material | Test Substance (ppm) | No. of Animals | |
Males | Females | |||
1 | Carrier Control Substance | 0 | 10 | 10 |
2 | POLYAMBROL® | 2500 | 10 | 10 |
3 | POLYAMBROL® | 5000 | 10 | 10 |
4 | POLYAMBROL® | 10000 | 10 | 10 |
ppm = Parts per million. |
The following parameters and end points were evaluated in this study: viability, clinical observations, body weights and body weight gains, food consumption, estrous cycle evaluations, cohabitation and mating, Functional Observational Battery (FOB), Motor Activity, clinical pathology parameters (hematology, coagulation, and clinical chemistry), thyroid hormone analysis, anogenital distance, nipple/areolae retention, organ weights, and histology and histopathology examinations.
Male Rats
The mean calculated doses for the male rats during the exposure period were 153.959, 300.235 and 572.937 in the 2500, 5000 and 10000 ppm exposure groups respectively.
All male rats survived until scheduled euthanasia.
There were no test substance-related clinical signs observed in the male rats.
There were no adverse changes in body weight, body weight gain or food consumption observed in the male rats during the exposure period.
There were no test substance-related effects on the Functional Observational Battery or motor activity evaluations in the male rats at exposure levels up to and including 10000 ppm.
There were no test substance-related differences in hematology, coagulation and clinical chemistry values in the male rats at exposure levels up to and including 10000 ppm.
No test article-related gross findings were noted in the male rats.
No test substance-related organ weight changes were noted in the male rats.
In the kidneys of males at ≥ 2500 ppm, POLYAMBROL®-related findings included an increased incidence and/or severity of chronic progressive nephropathy (CPN) as well as accumulation of hyaline droplets in the tubules of the renal cortex and degeneration/necrosis of tubules, predominately in the region of the corticomedullary junction. These findings are consistent with those reported in the literature where many chemicals have been found to exacerbate the incidence and/or severity of CPN and that hyaline droplet nephropathy was usually associated with a concomitant increase in the severity of CPN. Since the findings in these males were not dose-dependent, there were no increases in blood urea nitrogen or creatinine in the serum clinical chemistry, and the relevance to humans are uncertain, the findings were not considered adverse.
Female Rats
The mean calculated doses for the female rats during the premating period were 166.688, 315.399 and 568.682 in the 2500, 5000 and 10000 ppm exposure groups respectively. The mean calculated doses for the female rats during the gestation period were 181.490, 355.265 and 672.249 in the 2500, 5000 and 10000 ppm exposure groups respectively. The mean calculated doses for the female rats during the lactation period were 352.215, 649.204 and 1396.544 in the 2500, 5000 and 10000 ppm exposure groups respectively.
All female rats survived until scheduled euthanasia.
There were no test substance-related clinical signs observed in the female rats.
During the premating phase, there were statistically significant decreases in body weight gains at 5000 and 10000 ppm during the premating period (DSs 1 to 15). There were also statistically significant decreases in food consumption observed at 2500, 5000 and 10000 ppm during the premating period. On DSs 1 to 4, there were statistically significant decreases in body weight gains at 2500 and 5000 ppm and a statistically significant body weight loss observed at 10000 ppm. There were also statistically significant decreases in food consumption on DSs 1 to 4 and 11 to 15 at 5000 ppm and at all intervals at 10000 ppm.
There were no test substance-related effects on the Functional Observational Battery and motor activity evaluations in the female rats at exposure levels up to and including 10000 ppm.
There were no test substance-related differences in the hematology, coagulation or clinical chemistry values at exposure levels up to and including 10000 ppm.
There were no test substance-related gross findings, organ weight changes or any adverse histopathology in the P generation.
Based on the results of this study, the no-observed-adverse-effect-level (NOAEL) for general toxicity was 10000 ppm in the male rats and was not established in the female rats. In the females, reductions in body weight gain or a body weight loss and reduced food consumption were observed at all doses during the premating phase.
Justification for classification or non-classification
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.
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