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EC number: 233-135-0 | CAS number: 10043-01-3
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
White leghorn laying hens were fed diets containing 0, 0.15% (187.5mg/kg bw Aluminium sulphate) or 0.3% aluminium (375 mg/kg bw Aluminium sulphate) for 17 weeks. The LOAEL was based on significantly depressed fertility and chick body weight at 0.15% and these effects plus significantly reduced total egg production and feed consumption at 0.3% aluminium. Egg hatchability was unaffected.
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 310 mg/kg bw/day
Effect on fertility: via inhalation route
- Dose descriptor:
- NOAEC
- 38.6 mg/m³
Effect on fertility: via dermal route
- Dose descriptor:
- NOAEL
- 7.8 mg/kg bw/day
Additional information
Oral exposure:
The NOAEL (No Observed Adverse Effect Level) for effects on off-spring growth was 310 mg/kg/bw/day.
Growth was retarded and was dependent on the intake of aluminium, but the effect did not appear in the first generation or in the first litter. The subsequent litters manifested a very marked growth retardation, as did those of the third generation.
The NOAEL of 317 mg/kg/bw/day was based on.delay in vaginal opening. No effects on female fertility.delay in vaginal opening
The NOAEL of 633 mg/kg/bw/day was based on decreased forelimb grip strength, decreased pup body weight. No effects on female fertility.
There was a reduction of food consumption and maternal body weight gain during gestational days 7 -15 in the groups exposed to aluminium compared to the control group. There were no differences among the groups in the length of gestation, mean number of pups per litter, viability index, and pup body weight at birth.
For dermal exposure we taken that:
-the average weight of rats is 250g (200-300g),
-the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg
corrected dermal NOAEL= oral NOAEL
310 mg/kg bw/day 0.025 kg =
NOAELrat 7.8 mg/kg bw/day
Inhalation exposure:
No histological changes were observed in reproductive tissues of Fischer 344 rats or Hartley guinea pigs exposed by inhalation to 6.1 mg Al/m3 or 38.6 mg/m3 as aluminum chlorhydrate for 6 months (Steinhagen et al. 1978).
.Short description of key information:
The NOAEL (No Observed Adverse Effect Level) for effects on off-spring growth was 310 mg/kg/bw/day.
Growth was retarded and was dependent on the intake of aluminium, but the effect did not appear in the first generation or in the first litter. The subsequent litters manifested a very marked growth retardation, as did those of the third generation.
The NOAEL of 317 mg/kg/bw/day was based on.delay in vaginal opening. No effects on female fertility.delay in vaginal opening
The NOAEL of 633 mg/kg/bw/day was based on decreased forelimb grip strength, decreased pup body weight. No effects on female fertility.
There was a reduction of food consumption and maternal body weight gain during gestational days 7 -15 in the groups exposed to aluminium compared to the control group. There were no differences among the groups in the length of gestation, mean number of pups per litter, viability index, and pup body weight at birth.
Effects on developmental toxicity
Description of key information
From the results presented in 7.8.2 (Developmental toxicity / teratogenicity), a definitive No Observed Adverse Effect Level (NOAEL) for Aluminium sulphate of 40 mg/kg/day (injected intraperitoneally) and Lowest Observed Adverse Effect Level (LOAEL) for Aluminium sulphate of 276.8 mg/kg/day ( in drinking water ) were established, based on effects seen in brain, behaviour of the offspring and the activity of choline acetyltransferase (ChAT), at 276.8 mg/kg/day.
Effects recorded in mice included impaired performance of reflexes and simple behaviours (righting reflex, grasping, negative geotaxis, rod climbing).
Effect on developmental toxicity: via oral route
- Dose descriptor:
- LOAEL
- 276.8 mg/kg bw/day
Effect on developmental toxicity: via inhalation route
- Dose descriptor:
- NOAEC
- 12 mg/m³
Effect on developmental toxicity: via dermal route
- Dose descriptor:
- LOAEL
- 6.9 mg/kg bw/day
Additional information
Oral exposure:
From the results presented in 7.8.2(Developmental toxicity / teratogenicity a Lowest Observed Adverse Effect Level (LOAEL)
for Aluminium sulphate of 276.8 mg/kg/day or 750 mg/l was established, based on effects seen in brain, behaviour of the offspring and the activity of choline acetyltransferase (ChAT), at 276.8 mg/kg/day. Effects recorded in mice included impaired performance of reflexes and simple behaviours (righting reflex, grasping, negative geotaxis, rod climbing)
For dermal exposure we taken that:
-the average weight of rats is 250g (200-300g),
-the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg
corrected dermal LOAEL= oral LOAEL
276.8 mg/kg bw/day 0.025 kg =
LOAELrat 6.9 mg/kg bw/day
Inhalation exposure:
No studies were identified concerning the developmental effects of inhalation exposure to aluminum salts.
The oral dose for the mouse is converted to the corresponding air concentration using a standard breathing volume for the mouse (1.15 m3/kg for 24 hours exposure. The resulting air concentration needs to be additionally corrected for 24 hlight activity (20 m3), assuming 100 % absorption for both routes.
NOAELmouse
276.8 mg/kg bw/day
÷1.15m3/kgbw
÷20m3/mouse
NOAECmouse 12 mg/m3
Toxicity to reproduction: other studies
Additional information
This experiment in study of Wisser (1990) was conducted to evaluate the effectof aluminum exposure on productivity, fertility and hatchability.
Bythesecond week of treatment, 0.30% added dietary aluminum significantly decreased egg output. However, afterthe initial drop in production, hens fed this diet maintained consistent output and did not show signs ofinduced molt. Overall, production was not affected by0.15% added dietary aluminum but was reduced significantly by 0.30% aluminum. Feed consumption wassignificantly reduced by 0.30% added dietary aluminum.
There was no change in egg weight associated withdietary aluminum, which is consistent with a preliminary study. However, an unexpected significant increasein percent shell occurred in both groups receiving addedaluminum.
The addition of 0.30% dietary aluminum slightly but significantly lowered fertility. However, percent hatchability showed no significant changes.
Justification for classification or non-classification
Based on the hazard assessmentof aluminium sulphate in section 2.1 and 2.2.in IUCLID 5.2., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health” andaccording to the criteria described in Directive 67/548 and in the CLP Regulation:
Directive 67/548 |
Toxicity to reproduction/development Repr. Cat. 1; R61 May cause harm to the unborn child. Repr. Cat. 2; R61 May cause harm to the unborn child. Repr. Cat. 3; R63 Possible risk of harm to the unborn child. Toxicity to reproduction/fertility Repr. Cat. 1; R60 May impair fertility. Repr. Cat. 2; R60 May impair fertility. Repr. Cat. 3; R62 Possible risk of impaired fertility
|
CLP |
Reproductive toxicity Repr. 1A Repr. 1B Repr. 2 H360: May damage fertility or the unborn child <state specific effect if known > <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>. H361: Suspected of damaging fertility or the unborn child <state specific effect if known> <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
|
It is concluded that the substance aluminium sulphate does not meet the criteria to be classified for human health hazards for Reproductive toxicity
Additional information
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