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EC number: 287-337-9 | CAS number: 85480-57-5
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From January 14, 1985 to February 7, 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The experiment has been carried out before LLNA implementation (2002)
Test material
- Reference substance name:
- Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts
- EC Number:
- 270-115-0
- Cas Number:
- 68411-30-3
- IUPAC Name:
- Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Age at study initiation: 6-8 weeks
Weight at study initiation: 200-350 g
Housing: Makrolon cages, 5 per cage
Diet (e.g. ad libitum): 8GP17 guinea pig food, ad libitum
Water (e.g. ad libitum): ad libitum
Temperature (°C): 22 +/- 2
Humidity (%): 60 +/- 20
Air changes (per hr): 15
Photoperiod (hrs dark / hrs light): 12 h/12 h
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: intracutaneously and epicutaneously
- Vehicle:
- water
- Concentration / amount:
- 25% in water and Freund's Adjuvant
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 12.5% in deionized water
- No. of animals per dose:
- 10 males and 10 females
- Details on study design:
- Induction:
Induction was first done by intradermal injection. Test animals were injected with 0.1 mL Freund's Complete Adjuvant (FCA), 0.1 mL of 25% test substance in water, and 0.1 mL test substance in FCA in water (final concentration 25%). Control group was treated in a similar manner with only FCA and water. On Day 7, a second, epicutaneous challenge was done. 0.5 mL of test susbtance (25%) was placed on gauze, and then placed on the animals. The animals were then bandaged, and the test substance remained in contact for 48 h. Control animals were exposed to vehicle only.
Challenge:
0.2 mL of 12.5 % test substance was placed on gauze, which was then placed on the test and control animals. Gauze containing only vehicle was placed on the left flank. The exposure lasted 24 h. Observations for irritation were made at 24 and 48 h after the end of exposure. Skin was scored for irritation using the Draize scale. - Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- -
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no positive responses were observed
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 12.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no positive responses were observed
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the substance was not sensitizing to guinea pig skin.
- Executive summary:
A study was conducted to determine the skin sensitisation potential of the substance according to OECD Guideline 406, in compliance with GLP. Ten male and ten female Hartley guinea pigs were included in the experiement. The induction was first done by intradermal injection. Test animals were injected with 0.1 mL Freund Complete Adjuvant (FCA), 0.1 mL of 25% test substance in water, and 0.1 mL test substance in FCA in water (final concentration 25%). Control group was treated in a similar manner with only FCA and water. On Day 7, a second, epicutaneous challenge was done. 0.5 mL of test susbtance (25%) was placed on gauze, and then placed on the animals. The animals were then bandaged, and the test substance remained in contact for 48 h. Control animals were exposed to vehicle only. The challenge consisted of 0.2 mL of 12.5 % test substance placed on gauze, which was then placed on the test and control animals. Gauze containing only vehicle was placed on the left flank. The exposure lasted 24 h. Observations for irritation were made at 24 and 48 h after the end of exposure. Skin was scored for irritation using the Draize scale. No positive reactions were noted. Under the study conditions, the substance was not sensitizing to guinea pig skin (RBM, 1985).
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