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EC number: 939-523-2 | CAS number: 1471312-55-6
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 Aug - 27 Aug 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted in 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Alcohols, C8-10, ethoxylated, sulfates, sodium salts
- EC Number:
- 939-523-2
- Cas Number:
- 1471312-55-6
- Molecular formula:
- not available
- IUPAC Name:
- Alcohols, C8-10, ethoxylated, sulfates, sodium salts
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- paste
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI(Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: males: 7 - 8 weeks, females: 11 - 12 weeks
- Body weight at study initiation: males: 221 – 235 g, females: 212 – 229 g.
- Diet (ad libitum): Altromin 1324 maintenance diet for rats and mice (lot no. 0939)
- Water (ad libitum): tap water, sulphur acidified to a pH value of approximately 2.8
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approx. 10%
REMOVAL OF TEST SUBSTANCE
- Washing: The residual test item was removed using aqua ad injectionem
- Time after start of exposure: 24 h - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- 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: A careful clinical examination was made several times on the day of dosing. Thereafter, the animals were observed for clinical signs once daily. The animals were weighed on Day 1 (prior to the application) and on Days 8 and 15.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No mortality occured.
- Clinical signs:
- other: No clinical signs of toxicity occurred.
- Body weight:
- lower than 10% body weight loss
- Remarks:
- For details, please refer to Table 1 under "Any other information on results incl. tables".
- Gross pathology:
- Upon gross pathology hernia (liver) into the diaphragm was observed in one female. This incidental finding is not considered to be treatment related.
- Other findings:
- Signs of irritation:
Erythema grade 1 as well as eschar and desquamation were observed in 10/10 animals. Scratches were observed in 2/5 females. In 3/5 males and 4/5 females, all signs of irritation were not reversible within the observation period.
Any other information on results incl. tables
Table 1: Absolute Body Weights in g and Body Weight Gain in %
Animal No. / Sex |
Day 1 |
Day 8 |
Day 15 |
Day 1-15 |
21 / male |
226 g |
241 g |
282 g |
25 % |
22 / male |
231 g |
250 g |
292 g |
26 % |
23 / male |
230 g |
238 g |
274 g |
19 % |
24 / male |
221 g |
236 g |
270 g |
22 % |
25 / male |
235 g |
245 g |
282 g |
20 % |
Mean ± SD |
229 ± 5.3 g |
242 ± 5.6 g |
280 ± 8.5 g |
22 ± 3.0 % |
26 / female |
213 g |
215 g |
220 g |
3 % |
27 / female |
216 g |
213 g |
217 g |
0 % |
28 / female |
212 g |
205 g |
216 g |
2 % |
29 / female |
229 g |
227 g |
250 g |
9 % |
30 / female |
217 g |
223 g |
234 g |
8 % |
Mean ± SD |
217 ± 6.8 g |
217 ± 8.6 g |
227 ± 14.6 g |
4 ± 3.9 % |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- This study was performed according to OECD test guideline 402 and compliant with GLP. Under the conditions of this limit test, the median lethal dose (LD50) of the test item (technical substance) after a single 24-h dermal administration was found to be greater than 2000 mg/kg bw in male and female Crl:WI Wistar rats. It is concluded that the CLP/ EU GHS criteria are not met and that no classification is required according to Regulation (EC) No 1272/2008.
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