Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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Diss Factsheets
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EC number: 701-203-3 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study, tested with the source substance Sorbitan monolaurate, ethoxylated, < 2.5 EO (CAS 9005-64-5). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Sorbitan monolaurate, ethoxylated
- EC Number:
- 500-018-3
- EC Name:
- Sorbitan monolaurate, ethoxylated
- Cas Number:
- 9005-64-5
- Molecular formula:
- Molecular formula cannot be given as substance is a mixture.
- IUPAC Name:
- Sorbitan monolaurate, ethoxylated (1-6.5 moles ethoxylated)
- Details on test material:
- - Name of test material: PC-2012-412
- Molecular formula: UVCB
- Physical state: yellow viscous liquid
- Analytical purity: 100%
- Batch No.: ES61C86614
- Expiration date of the batch: 05 January 2014
- Storage condition of test material: at room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI(Han) (outbred, SPF-Quality)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: 271 g (males), 184 g (females)
- Housing: 5 animals per sex per cage in labelled Makrolon cages (type IV; height 18 cm)
- Diet (ad libitum, except during exposure): pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany)
- Water (ad libitum, except during exposure): tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: design of the exposure chamber was based on a flow past nose-only inhalation chamber. The chamber consisted of three animal sections with eight animal ports each. Each animal port had its own atmosphere inlet and exhaust outlet. The main inlet of the test atmosphere was located at the top section and the main outlet was located at the bottom section.
- Method of holding animals in test chamber: animals were placed in restraining tubes and connected to the animal ports
- Source and rate of air: mean total airflow was 15.7 L/min
- System of generating particulates/aerosols: the test substance formulation was transferred to a nebulizer (type 950, Hospitak Inc., Lindenhurst, NY, USA) by means of a rotating pump (type VL500 digit, VERDER Lab Tec GmbH & Co. KG, Haan, Germany) and nebulized with the use of pressurized air. In order to nebulize the test substance, the viscosity of the test substance was reduced by heating up the test substance container, the nebulizer and pressurized air by means of water baths, set at a temperature of approximately 60°C. The primary aerosol was diluted with pressurized air and passed through the exposure chamber.
- Treatment of exhaust air: from the exposure chamber the test atmosphere was passed through a filter before it was released to the exhaust of the fume hood.
- Temperature, humidity: 21.7-22.2°C, 33-54%
TEST ATMOSPHERE
- Brief description of analytical method used: samples were drawn through a glass fiber filter. The collected amount of test substance in the air sample was measured gravimetrically. Sample volumes were measured by means of a dry gas meter.
- Samples taken from breathing zone: samples were drawn from the test atmosphere through a tube mounted in one of the free animal ports of the middle section of the exposure chamber.
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: characterised twice during exposure. The samples were drawn (2 L/min) from the test atmosphere and collected with an 8 stage Marple personal cascade impactor containing fiber glass filters and a fiber glass back-up filter. Amounts of test substance collected were measured gravimetrically.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2.2 µm / 2 µm (stage 1) and 2.3 µm / 2 µm (stage 2) - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetric
- Duration of exposure:
- 4 h
- Concentrations:
- 5.1 ± 0.1 mg/L (analytical)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: During exposure, the animals were observed for mortality, behavioural signs of distress and effects on respiration 3 times and 1 and 3 hours after exposure. Afterwards they were observed once daily until day 15. Body weights were recorded on days 1, 2, 4, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights - Statistics:
- No statistical analysis was performed.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.1 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs of systemic toxicity were noted up to the end of the 14-day observation period.
- Body weight:
- Overall body weight gain in males and females was within the range expected for rats of this strain and age used in this type of study.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: 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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