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EC number: 257-297-7 | CAS number: 51581-32-9
- 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
GLP guideline study according to OECD 406
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:
- 1999-02-23 to 1999-05-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Adopted 17th July 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Suitable non-LLNA data was already available.
- Specific details on test material used for the study:
- - CAS No.: 51581-32-9
- Batch No.: TMFP 304
- Purity: at least 99 %
- Solubility in water: soluble
- Storage: In the refrigerator, in the dark
- Appearance: colorless liquid
- pH: 7.29 - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Gartenstrasse 27, D-33178 Borchen
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: approximately 6 weeks
- Weight at study initiation: 341 g to 454 g
- Housing: Makrolon cages type III with wire mesh lids, single caging
- Diet (e.g. ad libitum): Yes
- Water (e.g. ad libitum): Yes
- Acclimation period: approximately 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 60
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5 (v/v) in: physiological saline, 1 + 1 (v / v) blended with FCA (Freund's complete adjuvant)
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- test substance, 5 % (v / v) in physiological saline
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- FCA, 1 + 1 (v / v) blended with physiological saline
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 g per animal
- Day(s)/duration:
- 48 h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.5 mL of test substance
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.5 mL of deionised water
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20 animals for the test substance group
10 animals for the control group - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 48 h
- Test groups: Group C (test substance)
- Control group: Group K3 (negative control)
- Site: 2 cm X 4 cm
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 21- 22
- Exposure period: 24 h
- Test groups: Group C (test substance)
- Control group: Group K3 (negative control)
- Site: 2 cm X 2 cm
- Evaluation (hr after challenge): 24 and 48 h
OTHER: A preliminary test was carried out with 3 female guinea pigs, pretreated with FCA. 4 different concentrations of the test substance were administered intradermally and 7 days later 4 concentrations of the test substance were administered epicutaneously. The modes of application were the same as in the definitive study. The duration of exposure was 24 hours. The test substance was dissolved in corn oil for the intradermal injections and in acetone for the epicutaneous administration.
Test substance concentration for Intradermal exposure: 0.1, 1.0, 5.0 and 20.0 %
Test substance concentration for Epicutaneous exposure: 1, 10, 50 and 100 % - Challenge controls:
- 0.5 mL of test substance and 0.5 mL of deionised water were applied to each animal.
- Positive control substance(s):
- yes
- Positive control results:
- 90% (9/10) of the animals had a positive skin reaction. The results prove the sensitivity of the strain of animals used and the reliability of the experimental technique.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 5% TS intradermal + 100% TS epicutaneous; Challenge: 50% TS (left flank); water (right flank)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 5% physiological saline (intradermal) + water (epicutaneous); Challenge: 100% TS (left flank); water (right flank)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 5% TS intradermal + 100% TS epicutaneous; Challenge: 50% TS (left flank); water (right flank)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 5% physiological saline (intradermal) + water (epicutaneous); Challenge: 100% TS (left flank); water (right flank)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: periodic checks with known sensitizers (HEXYL ClNNAMIC ALDEHYDE)
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- intradermal induction: 0.5% in corn oil; epicutaneous induction: 50% in acetone; challenge: 10% in acetoneaceton
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, the test item is not considered to be skin sensitizing under the UN GHS Criteria.
- Executive summary:
In a dermal sensitization study (OECD 406) with the test item, 20 young adult female guinea-pigs of the HsdPoc: DH strain were tested using the method of Magnusson and Kligman. Two induction exposures (intradermally and epicutaneously) and one epicutaneous challenge exposure were performed. Observations were performed 24 and 48 h after the challenge exposure. All test substance treated sites of all animals of the negative control group and of the test substance group were normal at any observation time. No animal of the test substance group was regarded as sensitised.
Reference
Mortality: 2 animals died on Day 1 after the intradermal induction exposure, 2 animals on Day 8 and 5 animals on Day 9 after the epicutaneous induction exposure. The cause of death in each case was intestinal obstruction or shock after extensive inflammation of the bowels, considered to be test substance related.
Body weight: No significant differences in the mean body weights between the test substance group and the control group were observed
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In a dermal sensitization study according to OECD 406, 20 young adult female guinea-pigs were tested negative using the method of Magnusson and Kligman.
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