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EC number: 278-934-5 | CAS number: 78521-39-8
- 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:
- 2000-08-22 until 2000-10-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study according to OECD 406
- Justification for type of information:
- Study was performed in 2000 according to OECD 406, before REACH Regulation came into force. The available data is reliable without restriction and was used in order to meet the information requirements.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was performed in 2000 according to OECD 406, before REACH Regulation came into force. The available data is reliable without restriction and was used in order to meet the information requirements.
Test material
- Reference substance name:
- 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid
- EC Number:
- 278-934-5
- EC Name:
- 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid
- Cas Number:
- 78521-39-8
- Molecular formula:
- C13H19NO4S
- IUPAC Name:
- 6-(4-methylbenzenesulfonamido)hexanoic acid
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): ASC plus
- Substance type: powder
- Physical state: solid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Purity test date: no data
- Lot/batch No.: 0604
- Expiration date of the lot/batch: 12/2001
- Stability under test conditions: no data
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hasrlan Winkelmann GmbH
- Weight at study initiation: males: 339 - 431 g, females 334 - 362 g
- Housing: in groups of 5
- Diet (e.g. ad libitum): ad libitum, Harlan Teklad FD2 Guinea Pig Diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 21 days pilot study, 9 days main study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 16 times per hour
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 5%, 50%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5%, 50%
- No. of animals per dose:
- 5 male, 5 female
- Details on study design:
- RANGE FINDING TESTS:
1 male and 1 female guinea pig, intradermal injection of 0.1 ml of a 5 % formulation in water with Freund's complete adjuvans and
1 male and 1 female guinea pig, dermal application of 0.5 g of a 50% formulation in vaseline.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 48 h
- Test groups: one male and one female
- Control group: 3 male and 2 female animals
- Site: back
- Frequency of applications: single
- Duration: 48 h
- Concentrations: 0.5% and 5%
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: day 14 after the last induction
- Exposure period: 24 h
- Test groups: one male and one female
- Control group: 3 male and 2 female animals
- Site: back
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 hs - Challenge controls:
- positive control study from 2000-07-11 to 2000-08-04
- Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- Expected positive reaction was demonstrated.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g of a 50% formulation in vaseline.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no clinical signs observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no clinical signs observed
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g of a 50% formulation in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no clinical signs observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no clinical signs observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50% Benzocaine in vaseline
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- Erythema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50% Benzocaine in vaseline
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- Erythema and edema
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- ASC plus is not sensitising
- Executive summary:
ASC plus was tested in a guinea pig maximisation test according to OECD 406 for its sensitising properties. In 2 pilot studies with one male and one female animal in each study the effects of an intradermal injection of 0.1 ml of a 5% formulation in water with Freund's complete adjuvans and the effect of a dermal application of 0.5 g of a formulation in vaseline were tested.
48 hours after the end of the application no effects were seen in comparison to the pure vehicle.
In the main study with 5 male and 5 female animals a first induction was started with the intradermal injection of 0.1 ml of a 5 % formulation in water with Freund's complete adjuvans.
The second induction was done 7 days later by an occlusive dermal application of 0.5 g of a formulation in vaseline.
14 days after the end of the 2nd induction the challenge was done by an occlusive dermal application of a 50 % formulation in vaseline for 24 hours. The effect was controlled 24 and 48 hours after the end of the application.
The animals of the treatment group recieved also applications of vehicle only at another part of the back. 3 male and 2 female guinea pigs of a control group recieved vehicle only.
With the treatment groups no effects were seen at any time point during the study.
After treatment with pure vaseline a light reddening of the skin was observed at the time point 24 hours after the end of the challenge.
The positive control was done by a seperate study in the time from 2000-07-11 to 2000 -08 -04.
According to the results of this study ASC plus is not sensitising.
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