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EC number: 258-296-4 | CAS number: 53018-24-9
- 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
Endpoint summary
Administrative data
Description of key information
Under the conditions of this study the test material was determined to be a very weak sensitiser.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 April 1985 to 17 May 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The Magnusson and Kligman guinea pig maximisation test according to Test Method TM.002.03
The study was conducted in accordance with S.O.P.011/02 - GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study conducted prior to adoption of LLNA guideline by the OECD.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 312 - 349 g
- Diet: RGP pellets, hay and cabbage
- Water: ad libitum - Route:
- intradermal
- Vehicle:
- olive oil
- Concentration / amount:
- 0.25 %
- Day(s)/duration:
- 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Neat test material
- Day(s)/duration:
- 6-7 days after the intradermal induction
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone/PEG400
- Concentration / amount:
- 25 %
- Day(s)/duration:
- 12-14 days after epicutaneous induction. Patch was applied for 24 hours.
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone/PEG400
- Concentration / amount:
- 25 %
- Day(s)/duration:
- A second, third and fourth challenge were made at weekly or longer intervals as required and applied for 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 animals in the test group and 4 treated control animals.
- Details on study design:
- TREATMENT
Sensitisation was induced in guinea pigs by intradermal injections of both test material and Freund's Complete Adjuvant and the induction process supplemented 6-7 days later by test material applied to the shoulder injection sites under occlusion. 12-14 days later the animals were challenged by occluded patch: further challenges were made at weekly or longer intervals as required.
- induction (intradermal injection): 0.25 %
- induction (covered patch application): neat
- challenge (covered patch application): 25 %
EVALUATION- SCORING SYSTEM
- Challenge patches were applied for 24 hours. Skin reaction sites examined 24 and 48 hours after removal of the patches, and scored according to the following:
Intradermal Injection:
fp = Faint pink
pp = Pale pink
p = Pink
dp = Deep pink
el = Elevation/oedema
n = Necrosis
w = White centre
Occluded Patch
0 = No reaction
0.5 = Very faint erythema (usually non-confluent)
1 = Faint erythema (usually confluent)
2 = Moderate erythema
3 = Marked erythema
Sp = Small spots of erythema
n = Necrosis
el = Elevation/oedema
w = White centres - Challenge controls:
- Treated controls were used in the first and second challenges, untreated controls were used in the third and fourth challenges.
- Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 1
- Total no. in group:
- 9
- Clinical observations:
- Very faint erythema in one animal and faint erythema in one animal
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 1
- Total no. in group:
- 9
- Clinical observations:
- Very faint erythema in four animals and faint erythema in one animal
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: treated control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: treated control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 3
- Total no. in group:
- 9
- Clinical observations:
- Faint to moderate erythema in two animals and faint erythema in one animal
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 4
- Total no. in group:
- 9
- Clinical observations:
- Moderate erythema in one animal, faint erythema in three animals and very faint erythema in one animal.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- other: treated control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- other: treated control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Key result
- Reading:
- other: challenge 3
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 1
- Total no. in group:
- 9
- Clinical observations:
- Very faint erythema in five animals and faint erythema in one animal
- Key result
- Reading:
- other: challenge 3
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- Very faint erythema in four animals
- Key result
- Reading:
- other: challenge 3
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Key result
- Reading:
- other: challenge 3
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Key result
- Reading:
- other: challenge 4
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 2
- Total no. in group:
- 9
- Clinical observations:
- Very faint erythema in two animals, very faint to faint erythema in one animal, faint erythema in one animal and faint to moderate erythema with necrosis in one animal.
- Key result
- Reading:
- other: challenge 4
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 1
- Total no. in group:
- 9
- Clinical observations:
- Very faint erythema in two animals and faint to moderate erythema with necrosis in one animal.
- Key result
- Reading:
- other: challenge 4
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- Very faint erythema in one animal..
- Key result
- Reading:
- other: challenge 4
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- Very faint erythema in one animal..
- Interpretation of results:
- other: Not classified in accordance with EU Criteria
- Conclusions:
- Under the conditions of this study the test material was determined to be a very weak sensitiser.
- Executive summary:
The skin sensitisation potential of the test material was investigated with the Magnusson and Kligman guinea pig maximisation test according to Test Method TM.002.03.
Sensitisation was induced in guinea pigs by intradermal injections of both test material and Freund's Complete Adjuvant and the induction process supplemented 6-7 days later by test material applied to the shoulder injection sites under occlusion. 12-14 days later the animals were challenged by occluded patch: further challenges were made at weekly or longer intervals as required. The concentrations used in the test were: induction (intradermal injection): 0.25 %, induction (covered patch application): neat and challenge (covered patch application): 25 %.
Evidence of sensitisation seen in one animal at challenge one was not confirmed at subsequent challenges. Two animals showed a positive response twice each out of challenges 2, 3 and 4.
Under the conditions of this study the test material was determined to be a very weak sensitiser.
Reference
- Evidence of sensitisation seen in one animal at challenge one was not confirmed at subsequent challenges. Two animals showed a positive response twice each out of challenges 2, 3 and 4.
- The test material is a very weak sensitiser by this method.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitisation potential of the test material was investigated with the Magnusson and Kligman guinea pig maximisation test according to Test Method TM.002.03. The study was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997).
Sensitisation was induced in guinea pigs by intradermal injections of both test material and Freund's Complete Adjuvant and the induction process supplemented 6-7 days later by test material applied to the shoulder injection sites under occlusion. 12-14 days later the animals were challenged by occluded patch: further challenges were made at weekly or longer intervals as required. The concentrations used in the test were: induction (intradermal injection): 0.25 %, induction (covered patch application): neat and challenge (covered patch application): 25 %.
Evidence of sensitisation seen in one animal at challenge one was not confirmed at subsequent challenges. Two animals showed a positive response twice each out of challenges 2, 3 and 4.
Under the conditions of this study the test material was determined to be a very weak sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with skin sensitisation.
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