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EC number: 263-417-9 | CAS number: 62121-75-9
- 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
The test item did not show any signs of sensitising properties in an OECD 406 guinea pig maximisation test.
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:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- In vivo test (maximisation test) was available already.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Pirbright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, breeding colony, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Weight at study initiation: mean = 334 g (n = 30)
- Housing: in fully air-conditioned rooms in Makrolon cages on soft wood granulate, in groups of 5 animals
- Diet (e.g. ad libitum): Altromin 3112, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 d
- Indication of any skin lesions: none
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 20%
- Air changes (per hr): fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12:12
Identification with cage numbering and fur-marking (KMnO4) - Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 2 x 0.1 ml 50% Freund's Adjuvant
2 x 0.1 ml 5% solution of test substance in isotonic saline
2 x 0.1 ml 5% solution of test substance in 50% Freund's adjuvant - Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 25% / 0.5 mL
- Day(s)/duration:
- Day 8 for 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 25% /0.5 mL
- Day(s)/duration:
- Day 22 for 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 25% / 0.5 mL
- Day(s)/duration:
- Day 29 for 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Control group: 10
Treatment group: 20 - Details on study design:
- RANGE FINDING TESTS:
Intradermal: 0.2, 2, 5% in isotonic saline
Dermal: 1, 5, 25% in isotonic saline
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal; 1 dermal
- Exposure period: Day 1 and Day 8
- Test groups: 1
- Control group: 1
- Site: neck
- Frequency of applications: single
- Duration: 48 h
- Concentrations: 5% and 25%
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: Day 22 and Day 29
- Exposure period: 24 h
- Test groups: 1
- Control group: 1
- Site: flank
- Concentrations: 25%
- Evaluation (hr after challenge): 24 and 48 h after patch removal
OTHER: - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Positive control results:
- valid
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- None of the 20 animals in the treatment group showed a positive response after the repeated challenge procedure. The test substance did not show evidence for sensitizing properties.
- Executive summary:
Testing for sensitizing properties of the test substance was performed in female Guinea pigs according to the method of MAGNUSSON & KLIGMAN.
Intradermal induction was performed using 5.0 % test substance in isotonic saline. Dermal induction as well as first and second challenge treatment were carried out with 25 % test substance in isotonic saline.
Based on the results of this study there is no evidence for sensitizing properties.
Reference
Body weight gains and clinical signs
The treated animals showed no clinical signs of intoxication throughout the study.
The intradermal injections with Freund's Adjuvant (with and without test substance) caused severe erythema and oedema as well as indurations and encrustations. The intradermal injections with the test substance in the vehicle caused very slight erythema and oedema. The intradermal applications of the vehicle alone caused no signs of irritation. Additionally the application sites treated with the test substance in Freund's Adjuvant and in the vehicle were discoloured yellow.
Due to these strong irritation reaction of the skin, 10% sodium dodecylsulfate was not applied at day 7.
After the removal of the patch at day 10, erythema and oedema, indurated, scabbed and encrusted skin as well as necrosis and open wounds were observed at the sites previously treated with Freund's Adjuvant. The injection sites treated with the test substance in the vehicle and the vehicle alone showed no signs of irritation. Additionally the skin of the animals in the treatment group was discoloured yellow.
The body weight gains of the treated animals were not impaired.
Challenge treatment
48 hours after removal of the patches five animals of the treatment group showed very slight and one animal a well-defined erythema. Additionally the skin of all animals was discoloured yellow-orange. No signs of irritation occurred in the animals of the control group.
Repeated challenge treatment
No signs of irritation were observed 24 and 48 hours after removal of the occlusive bandage in the control group and in the treated group. The skin of the animals was discoloured yellow-orange
Under the conditions of the present study, none of twenty animals of the treatment group showed a positive skin response after the repeated challenge procedure. Therefore, the positive skin reactions after the first challenge procedure cannot be attributed to a sensitizing potential.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
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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