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Diss Factsheets
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EC number: 939-273-4 | 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May 16, 2012 to June 20, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant with international guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- Protocol deviations with no negative impact on the study.
- Deviations:
- yes
- Remarks:
- Protocol deviations with no negative impact on the study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- Protocol deviations with no negative impact on the study.
- Deviations:
- yes
- Remarks:
- Protocol deviations with no negative impact on the study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Paraffin waxes and Hydrocarbon waxes C14-17, chloro, sulfochlorinated, low sulphonated, saponified
- EC Number:
- 939-273-4
- Molecular formula:
- CnHxCly(SO3Na)z • n= 14-17 • z < 0,5 • y = 0 ÷ 2,7
- IUPAC Name:
- Paraffin waxes and Hydrocarbon waxes C14-17, chloro, sulfochlorinated, low sulphonated, saponified
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Italy
- Age at study initiation: 6-8 weeks old
- Weight at study initiation: 176 to 200 g
- Housing: limited access rodent facility, individually housed in polisulphone solid bottomed cages measuring 59 x 38.5 x 20 cm. Nesting material will be provided inside suitable bedding bags; nesting material will be changed at least twice a week.
- Diet: A commercially available laboratory rodent diet (4RF18 Mucedola) will be offered ad libitum throughout the study.
- Water: Drinking water will be supplied ad libitum to each cage via water bottles.
- Acclimation period: 5 days
- Health check: yes
ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 2°C
- Humidity: 55% ± 15%
- Air changes: 15 to 20 air changes per hour
- Photoperiod: 12 hours cycle dark/light
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 5 x 7 cm
- % coverage: 10%
- Type of wrap if used: A patch of surgical gauze covered by a strip of synthetic film was placed over the treated site and the whole assembly held in place by encircling the trunk of the animal with a length of elastic adhesive bandage, this forming a semi-occlusive barrier.
REMOVAL OF TEST SUBSTANCE
- Washing: The treatment area was cleaned by gentle swabbing of the skin with cotton wool soaked with lukewarm water. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw based on active ingredient
- No. of animals per sex per dose:
- 5 x sex x dose
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Duration of observation period following administration: 14 days
- Signs: Day of dosing (on dosing, approximately 1, 2 and 4 hours after dosing), Daily thereafter (14 days).
- Bodyweight: Allocation (Day -1), Days 1, 8 and 15.
- Necropsy of survivors performed: yes
Animals in extremis and those that have completed the scheduled test period will be killed with carbon dioxide.
- Other examinations performed: All animals will be subjected to gross examination including the opening of the cranial, thoracic and abdominal cavities and the examination of the major organs. Particular attention will be paid to the treatment site. All abnormalities will be recorded.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred in male or female animals following treatment.
- Clinical signs:
- other: remarks
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as toxic according to the CLP Regulation (EC) No. 1272/2008
- Conclusions:
- Results indicate that the test item, PARAFFIN WAXES AND HYDROCARBON WAXES, CHLORO,SULFOCHLORINATED SAPONIFIED (C14-C17) SSP-SAMPLE 1, has no systemic toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg.
- Executive summary:
The acute toxicity of PARAFFIN WAXES AND HYDROCARBON WAXES, CHLORO,SULFOCHLORINATED SAPONIFIED (C14-C17) SSP-SAMPLE 1 was investigated following dermal administration of a single dose to the rat. A single dose of 2000 mg/kg was administered to a group of 5 male and 5 female animals for 24 hours. After 14 days all animals were killed and subjected to necropsy examination.
No mortality occurred in male or female animals after treatment during the observation period. Clinical signs observed were limited to the treatment site in which redness and/or scabs and/or desquamation and/or fissuring were generally observed during the study. However, all males recovered from these signs by Day 13 while all females by Day 15. The reaction in the treated site demonstrates that the test item was not well tolerated by the skin of the rats after 24 hours of semi-occlusive exposure. The body weight changes observed during the study were within the expected range for this species and age of animals.
No abnormalities were found at necropsy carried out in the animals at termination of the study.
These results indicate that the test item, PARAFFIN WAXES AND HYDROCARBON WAXES, CHLORO,SULFOCHLORINATED SAPONIFIED (C14-C17) SSP-SAMPLE 1, has no systemic toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg. European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) would indicate the following:
Classification: No Category
Signal word : No Signal word required
Hazard statement: No hazard statement required
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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