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EC number: 602-997-3 | CAS number: 124495-18-7
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA test was also conducted (see Report 243491). Results of the LLNA test were negative. The results of this guinea pig maximazation test were positive and were therefore chosen as a key study along with the LLNA test. This study was conducted in 1995 whereas the LLNA test was conducted in 2007.
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 124495-18-7
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Name of substance: XDE-795 Technical
- Lot No.: RMM 2008
- Purity: 97.5%
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: purified water
- Concentration / amount:
- 0.1 mL of Freunds complete adjuvant (FCA)
- Day(s)/duration:
- single injection at least five days before topical application
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- First induction: 1% w/v
Sencond induction: 50% w/v - Day(s)/duration:
- 48 hours
- Adequacy of induction:
- highest technically applicable concentration used
Challengeopen allclose all
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- other: purified water
- Concentration / amount:
- 0.1 mL FCA
- Day(s)/duration:
- single injection at least 20 days before topical challenge
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 10, 50% w/v
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Test group: 10 per sex per dose
Congrol group: 5 per sex per dose - Challenge controls:
- Propylene glycol, 10 and 50% w/v test substance in propylene glycol
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% w/v
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% w/v
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% w/v
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% w/v
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Repeated administration of the test substance caused delayed contact hypersensitivity in guinea pigs
- Executive summary:
The potential of the test substance to cause delayed contact hypersensitivity in the guinea-pig was assessed by the Magnusson-Kligman Maximisation Test following OECD guideline 406.
The closely-clipped dorsa of ten male and ten female Dunkin-Hartley guinea-pigs were subject to intradermal injections of Freund’s Complete Adjuvant, 1% w/v test substance in propylene glycol and 1% w/v test substance in the adjuvant on Day 1. On Day 7, the same area was treated with sodium lauryl sulphate to enhance the dermal penetration of the following dose. On Day 8, 50% w/v test substance in propylene glycol was applied topically and the test site was covered by an occlusive dressing for 48 hours. The same induction procedures were carried out on a contemporaneous control group of five male and five female animals, except that the test material was replaced by vehicle in all doses.
On Day 22, all animals were challenged by occluded topical application of propylene glycol to the left flank and 50% w/v test substance and 10% w/v test substance in propylene glycol to two sites on the right flank. The occlusive dressings were removed on the following day and the condition of the test sites was assessed approximately 24 and 48 hours later.
Intradermal injection of 1% w/v test substance in propylene glycol caused moderate erythema, eschar and occasional pallor, while intradermal injection of 1% w/v test substance in propylene glycol in FCA caused slight or moderate erythema and pallor. Intradermal injection of FCA alone caused moderate erythema in all animals. Topical induction application of 50% w/v test substance in propylene glycol caused barely perceptible or slight erythema, exfoliation and occasional eschar.
Challenge application of 50% w/v test substance in propylene glycol gave rise to a significant response (slight erythema or a more marked reaction) in eighteen test animals and no controls. Challenge application of 10% w/v test substance in propylene glycol gave rise to a significant response in nine test animals and no controls. Challenge application of propylene glycol alone caused no significant response.
It is concluded that, under the conditions of this study, repeated administration of test substance in propylene glycol caused delayed contact hypersensitivity in guinea-pigs, and is classified as a dermal sensitizer.
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