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Diss Factsheets
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EC number: 444-240-8 | 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 September 2001 to 17 October 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 444-240-8
- EC Name:
- -
- Cas Number:
- 302933-83-1
- Molecular formula:
- C55-n H95.5-2n N7 013 Na1.5 (n-0-6) molecular weight: 1097-l4n (n=0-6)
- IUPAC Name:
- Sodium surfactin
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Lot No S1038
White powder
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: 8 to 12 weeks
- females nulliparous and non-pregnant
- Weight at study initiation: 200 to 350
- Fasting period before study: None
- Housing: groups of 5 by sex in cages
- Diet (e.g. ad libitum): ad libitum except during exposure period
- Water (e.g. ad libitum): ad libitum except during exposure period
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/- 2°C
- Humidity (%): 55+/-15%
- Air changes (per hr): >15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- clean air
- Mass median aerodynamic diameter (MMAD):
- > 1.87 - < 2.02 µm
- Geometric standard deviation (GSD):
- > 2.71 - < 3.24
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: cylindrical exposure chamber (ADG Developments)
- Exposure chamber volume: 30L
- Method of holding animals in test chamber:tapered polycarbonate restraining tube
- Source and rate of air: SAG 410 (TOPAS)
- Method of conditioning air: compressed air from oil free compressor and passed trhough water trap and respiratory filters
- System of generating particulates/aerosols: Test material was ground.
- Method of particle size determination: Marple Personal Cascade Impactor
- Temperature, humidity, pressure in air chamber: maesured every 30 minutes during exposure period
TEST ATMOSPHERE
- Brief description of analytical method used: gravimetirc
- Samples taken from breathing zone: vacant port
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: a pre-exposure sighting of 1 mg/L - Analytical verification of test atmosphere concentrations:
- no
- Remarks:
- Gravimetric
- Duration of exposure:
- 4 h
- Concentrations:
- group 1, 0.49, group 2, 1.03 and group 3, 1.94 mg/L achieved
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: wiegjings at pre-exposure, 7 and 14 days or at death. Clinical signs at hourly intervals during exposure, immediately on removal from the restraaining tubes at end of exposure, one hour after termination of exposure and subsequently daily.
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic abnormalities recorded and a detailed macroscopic examination for signs of irritancy or local toxicity of the respiratory tract
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 1.42 mg/L air
- Based on:
- test mat.
- 95% CL:
- > 1.25 - < 1.62
- Exp. duration:
- 4 h
- Mortality:
- Group 3 (1.94 mg/L) 4/5 males and 4/5 females
Group 2 (1.03 mg/L) 1/5 males and 1/5 females
Group 1 (0.49 mg/L) 0/5 males and 0/5 females - Clinical signs:
- other: Clinicl signs associated with restraint procedure were seen. Increased respiratory rates in all groups.
- Body weight:
- Body weight loss during week in males and 2 females showed a reduced bodyweight gain in week 1
- Gross pathology:
- No macroscopic abnormalities were noted amoungst survivingg animals at terminal kill. For animals that died on study abnormailities were detected in the lungs (haemorrhagic, fluid filled, abnormally red and dark patches).
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- LC50 of 1.42 mg/L following a 4-hour exposure
- Executive summary:
Groups of 10 (5 male/5 female) Sprague-Dawley rats were exposed to a dust atmosphere (nose only system) for 4 hours followed by a 14 -day observation period.
The acute inhalation median lethal concentrations (LC50) and 95% confidence limits were:
All animals : 1.42 (1.25 -1.62) mg/L
Males only : 1.42 (1.25 -1.62) mg/L
Females only : 1.42 (1.25 -1.62) mg/L
Group Mean Achieved Atmosphere Concentration (mg/L) MMAD (um) Inhalabe Fraction (%<4 um) Geometric Std Dev 3 1.94 1.91 73.7 3.19 2 1.03 2.01 75.3 2.71 1 0.49 1.87 74.0 Group Mean Achieved Atmosphere Concentration (mg/L) Male deaths Female deaths
Total deaths
3
1.94
4/5
4/5
8/10
2
1.03
1/5
1/5
2/10
1
0.49
0/5
0/5
0/10
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