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Diss Factsheets
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EC number: 432-070-7 | 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
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Acute Toxicity: inhalation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02/0215 to 04/2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): BLANCOLEN HP Disodiumhydroxy(sulfonato)acetate
- Substance type: sulfonic acid derivative
- Physical state: solid
- Analytical purity: 98 %
- Lot/batch No.: 09102303
- Expiration date of the lot/batch: 09.12.2013
- Stability under test conditions: stable
- Storage condition of test material: room temperature
Constituent 1
- Specific details on test material used for the study:
- Sample Name: FA8
Batch: 14102401
Supplier: Brüggemann Chemical, L. Brüggemann KG
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Supplier: Charles River C/Argenters 7, Local AB 08290 Cerdanyola del Vallés Barcelona – Spain.
Health status: Specific Pathogen Free (SPF).
Rationale for selection of species / strain: The Sprague Dawley rat is a suitable rodent strain, acceptable to regulatory authorities as a recommended rodent test system, and for which extensive background data are available.
Total number of animals: 8: 6 used in the study (3 males and 3 females, allocated to first dose level (5.16 mg/mL) and 2 spare animals.
Age of the animals at exposure: 8 weeks
Animals per cage (before / after distribution): 4 (before distribution), 3 (after distribution)
Bedding material: Capsumlab Lecho_10 (autoclavable)
Change of cages: Once a week.
Inclusion criteria on arrival: Veterinary inspection.
Acclimatisation period: 8 days.
Animal identification: Digit ink marks.
Light cycle: 12:12, 07.00 to 19.00 CET
Pressure gradient: Animal holding room positive to corridors
Temperature: 18.6-23.5ºC
Relative humidity: 20-47%
Food: Global Diet
Reference: 2914 C
Supplier: Harlan Teklad Station Road Blackthorn, Bicester Oxon, OX25 1TP United Kingdom
Nutritional and contaminant contents:Certificate of analysis for the batch used is included in annex II
Food availability: Ad libitum, except when animals were restrained in the exposure tubes
Drinking water: Tap Water
Watering: Bottles
Quality control: Certificate of analysis is included in annex III
Water availability: Ad libitum, except when animals were restrained in the exposure tubes
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- > 1 - < 4 µm
- Geometric standard deviation (GSD):
- > 1.5 - < 3
- Details on inhalation exposure:
- Inhalation exposure was performed using a flow-past, nose-only exposure system. The animals were confined separately in restraint tubes which were positioned radially around the exposure chamber. The exposure system ensured a uniform distribution and provided a constant flow of test material to each exposure tube. The flow of air at each tube was approximately 1 L/min, which was sufficient to minimize re-breathing of the test aerosol as it is more than twice the respiratory minute volume of rats.
Exposure chambers type EC-FPC-232 (anodised aluminium, volume inside compartment: approximately 3 L), equipped with glass exposure tubes were used. The rats were individually exposed in glass tubes matching their size. Before treatment start the homogeneity for the different levels of the exposure chamber was confirmed. Cross and longitudinal sections of the chamber are shown in Figure 1.
The temperature and relative humidity of the test atmosphere in the exposure chamber was maintained as required by experimental conditions. Air flow was monitored regularly. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetric
- Duration of exposure:
- 4 h
- Concentrations:
- 5.16 mg/l
- No. of animals per sex per dose:
- 3 males, 3 females
- Control animals:
- no
- Details on study design:
- The test was based on a stepwise procedure. The starting dose (5 mg/L air, during 4 hours) was selected since the test item was expected to be non-toxic according to previous studies conducted by sponsor. No additional doses were required.
3 male and 3 female rats in group A (starting dose group) were exposed for 4 consecutive hours.
During an observation period of 14 days, clinical observations and body weight were collected in order to characterise the toxicological effects of the aerosol. All animals were subjected to a gross necropsy and descriptions of all macroscopic abnormalities were recorded.
Acclimatisation to the nose-only restraining tubes was performed for approximately 80 minutes immediately before the exposure. - Statistics:
- No statistical analysis was performed.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.16 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- none
- Clinical signs:
- other: Dirty fur, chromorrhinorrhea, chromodacryorrhea and piloerection were observed in all animals immediately after administration and 1 hour after exposure. These clinical signs were not longer present on day 2 of study and no other clinical signs were obser
- Body weight:
- A slight decrease in body weight (approximately 1-2% less than body weight at pre-treatment) was observed in all animals from day 1 of study to day 2 of study. Males recovered the body weight at pre-treatment at day 3 of study. Thereafter, a normal body weight gain was observed in males. By contrast, a stagnation of body weight was observed in females, which did not recover the body weight at pre-treatment until day 6 of study. Females gained weight normally from day of study 6 onwards.
- Gross pathology:
- No macroscopic findings were observed during necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No classification according to (EU) No. 1272/2008 required.
- Executive summary:
Treatment of Sprague Dawley rats with the test item resulted in no deaths. Clinical signs were considered to be mainly stress related to the nose-only exposure but a contribution of the treatment with the test item cannot be completely excluded. Additionally, body weight stagnation in females is considered to be related with the test item.
It is concluded that, under the experimental conditions:
- LC50 of the test item was greater than 5.16 mg/L air (gravimetric aerosol concentration)
- Based on the GHS classification criteria, the test item can be considered as not classified.
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.
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