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EC number: 240-702-6 | CAS number: 16652-76-9
- 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:
- 23.10.1995 - 16.11.1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- O-benzyl-L-valine toluene-p-sulphonate
- EC Number:
- 240-702-6
- EC Name:
- O-benzyl-L-valine toluene-p-sulphonate
- Cas Number:
- 16652-76-9
- Molecular formula:
- C12H17NO2.C7H8O3S
- IUPAC Name:
- O-benzyl-L-valine toluene-p-sulphonate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: intradermal: peanut oil, epicutaneous: vaseline
- Concentration / amount:
- Intradermal induction: 0.5% (w/v) in peanut oil
Epidermal induction: 50% (w/v) in vaseline
Challenge: 10% (w/v) in vaseline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: intradermal: peanut oil, epicutaneous: vaseline
- Concentration / amount:
- Intradermal induction: 0.5% (w/v) in peanut oil
Epidermal induction: 50% (w/v) in vaseline
Challenge: 10% (w/v) in vaseline
- No. of animals per dose:
- 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 0%, challenge: 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction: 0%, challenge: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 0.5 and 50%, challenge: 10%
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: 0.5 and 50%, challenge: 10%. No with. + reactions: 6.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 0%, challenge: 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: 0%, challenge: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 0.5 and 50%, challenge: 10%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: 0.5 and 50%, challenge: 10%. No with. + reactions: 7.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Intradermal Induction Pretest
After duplicate testing of the test substance at concentrations of 0.5, 1, 3 and 5% in peanut oil, severe irritation was seen at the site of intradermal injection with either 1, 3 or 5% of the test article. Consequently, a concentration of 0.5% was suitable for injection, systemically well tolerated and chosen for intradermal induction in the maximisation test owing to mild to moderate skin irritating properties.
Epidermal Application Pretest
Incorporation of the test article into vaseline was limited to 50%. After duplicate testing of the test substance at concentrations of 10, 30 and 50%, irritant skin reactions were seen in animals treated with either 30 or 50% of the test article. The concentration of 10% was the highest non-irritant dose. Therefore, a concentration of 50% was selected for epidermal induction and 10% for the topical challenge.
Guinea Pia Maximisation Test
After removal of the occlusive dressing on day 10 after epidermal induction, irritation at the applicat:ion site was seen in all 20 guinea pigs of the test groups. Epidermal challenge resulted in posit:ive responses in 6 of 20 guinea pigs (1 male, 5 females) after 24 hours and in 7 of 20 (1 male, 6 females) after 48 hours, corresponding to a sensitisation rate of 35%. Very slight erythema reactions in 1 male and 1 female faded after the scoring at 24 hours and were recognised as transient irritation (false-positive reaction) based on clinical appearance and duration. Scaling erythema was recorded in 1 male and in 5 females after 48 hours. No irritant skin reactions were recorded among control animals.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: skin sens 1B, H317
DSD: Xi, R43
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