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EC number: 427-240-2 | CAS number: 134841-35-3
- 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:
- January 17, 1995 - February 7, 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD-Guideline 406, "Skin Sensibilization", July 7, 1992. "Guinea Pig Maximisation Test" Good Laboratory Practice (OECD-Principles of Good Laboratory Pratice, Enviromnent Monograph No. 45, Paris, 1992)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same 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)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Authorisation letter are attached in "Attached full study report"
- Type of study:
- guinea pig maximisation test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Animal maintenance:
Hygiene: improved hygienic conditions
Room numer: EH1-19
Room temperature: average of c.a. 22°C
Relative humidity: average of 40%
Control of room temp. and rel. humidity: continuous control and recording
Air excange: ca. 12/h
Light: only artificial light from 6.00 a.m. tio 6.00 p.m.
Cages: Makrolon type III (23 cm x 39 cm x 15cm) with wire mesh lids, single caging.
Feed: Altromin Standard Diet No. 3022, ad libitum, offered in stainless steel containers. Analysis of feed for ingredients and contaminants are performed radomly by Altromin GmbH, D-32791 Lage
Bedding material: wood chip (aspen) from FINN TAPVEIKY, SF-73600 Kaavi Reduction of microorganism by autoclaving.
Water: tap water, acidified with HCl to pH=3, offered in Makrolom bottles with stainless steel canules, ad libitum.
Identification of the animals: numbers tattooed in the pinna of the right ear.
Acclimatisation: c.a. 2 weeks.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Physiological saline for the intratermal induction exposure. Withe perolatum (OAB9) or the epicutaneus induction exposure and for the callenge exposure
- Concentration / amount:
- 5% in physiological saline for the intratermal induction
40% in white petrolatum for epicutaneous induction
37.5% in white petrolatum for the challenge exposure
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: Physiological saline for the intratermal induction exposure. Withe perolatum (OAB9) or the epicutaneus induction exposure and for the callenge exposure
- Concentration / amount:
- 5% in physiological saline for the intratermal induction
40% in white petrolatum for epicutaneous induction
37.5% in white petrolatum for the challenge exposure
- No. of animals per dose:
- 10
- Positive control substance(s):
- yes
- Remarks:
- 1,4-phenylenediamine
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 37.5%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 37.5%. No with. + reactions: 9.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 37.5%
- 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: 37.5%. No with. + reactions: 7.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 37.5%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 37.5%. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 37.5%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 37.5%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Conclusions:
- The net rate sensitized test substance group animal was obtained by subtracting the percentage of positively reaction control group animals from the percentage of sensitized test substance group animals and was therefore 35% (45% minus 10%).
According to EC-Guideline 93/21 (April 27 , 1993), the test substance “D-VAL-DANE” should be labelled with “R43 May cause sensitization by skin contact”
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