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EC number: 260-789-4 | CAS number: 57526-50-8
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Based on the negative results of a Magnusson-Kligman Sensitisation Assay the substance is considered not to be skin sensitising.
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:
- Initiation: July 13, 1983 - Termination: September 15,1983.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study, no information on test item purity, no positive control
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 12 May 1981
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- study performed before LLNA method was established
- Specific details on test material used for the study:
- No information on purity. However, as it is stated in the section 13, the substance and its composition have remained essentially the same over the last decades.
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Weight at study initiation: mean 233.4 g (range: 189-261)
- Housing: in groups of 5 per cage in fully air-conditioned rooms
- Diet: mixed feed for breeding rabbits and guinea pigs ERKA 8300 (R. Koch OHG, Hamm), ad libitum
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 55 +/- 10 %
- Photoperiod (hrs dark / hrs light): 12 hours per day - Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- a) 50 % FCA in isotonic saline; b) test substance (5 %) in vehicle; c) test substance (5 %) in FCA
- Day(s)/duration:
- 1 d
- 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:
- pure substance
- Day(s)/duration:
- 2 d
- Adequacy of induction:
- highest technically applicable concentration used
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- pure test substance
- Day(s)/duration:
- 1 d
- Adequacy of challenge:
- other: highest technically applicable concentration used
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 50% in vehicle
- Day(s)/duration:
- 1
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 animals in control group, 20 in test group
- Details on study design:
- 1st application: Induction 5 % intracutaneous
(day 1)
2nd application: Induction 100 % occlusive epicutaneous (day 9)
3rd application: Challenge, pure substance occlusive epicutaneous (day 22)
4th application: Challenge 50 % occlusive epicutaneous (day 35, after effects of first challenge totally subsided) - Challenge controls:
- 2
- Positive control substance(s):
- not specified
- Positive control results:
- not specified
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% in petrolatum
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- marginal to well defined erythema
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% in petrolatum
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- marginal erythema, hardened skin
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50% in petrolatum
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- marginal erythema
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50% in petrolatum
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- marginal (5) to well defined (1) erythema
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this test the test substance did not show sensitising properties.
- Executive summary:
The sensitizing properties of the test substance were investigated in a Magnusson & Kligman test according to OECD Guideline 406 and GLP. Intradermal induction was performed with 5% test substance in parraffin and dermal induction with undiluted test item. First challenge was performed with undiluted test substance. However, due to irritating effects already observable in the control group no evaluation with respect to sensitising effects was possible. The second challenge was performed with undiluted test substance (left flank) and 50% test substance in petrolatum (right flank). Again, no evaluation of the left flanks was possible due to irritating effects already observable in the control group. Treatment with 50% test substance in petrolatum did not cause skin sensitisation.
Reference
first challenge / undiluted test substance:
first reading (24 h after patch removal: 9/10 (90%) control animals with erythema and 14/20 (70%) of test animals with erythema
second reading (48 h after patch removal: 5/10 (50%) control animals with erythema and 12/20 (60%) of test animals with erythema; no oedema in control animals, 1/20 test animals with oedema
second challenge/ undiluted test substance:
first reading (24 h after patch removal: 10/10 (100%) control animals with erythema and 14/20 (70%) of test animals with erythema; 5/10 (50%) controls animals with oedema and 1/20 (5%) test animals with oedema
second reading (48 h after patch removal: 8/10 (80%) control animals with erythema and 15/20 (75%) of test animals with erythema;
4/10 (40%) controls animals with oedema and 3/19 (16%) test animals with oedema
second challenge / 50% test substance in petrolatum:
Skin reaction 24 hours after patch removal:
No difference was noted between control and treated animals.
Skin reaction 48 hours after patch removal:
Marginal skin reactions were noted in treated animals: 5% increase in weak erythema and 5% increase in well-defined erythema compared to the control group.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The sensitizing properties of the test substance were investigated in a Magnusson & Kligman test according to OECD Guideline 406 and GLP. Intradermal induction was performed with 5% test substance in parraffin and dermal induction with undiluted test item. First challenge was performed with undiluted test substance. However, due to irritating effects already observable in the control group no evaluation with respect to sensitising effects was possible. The second challenge was performed with undiluted test substance (left flank) and 50% test substance in petrolatum (right flank). Again, no evaluation of the left flanks was possible due to irritating effects already observable in the control group. Treatment with 50% test substance in petrolatum did not cause skin sensitisation.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available experimental results the substance has not to be classified as skin sensitising according to Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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