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EC number: 611-084-9 | CAS number: 54041-17-7
- 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
Endpoint summary
Administrative data
Description of key information
Using the maximization test of MAGNUSSON and KLIGMAN, the test substance was tested on male guinea pigs to determine whether it has skin sensitizing properties.
The following test substance concentrations were used in the test: Intradermal induction: 5%; Topical induction: 50%; Challenge: 50% and 25%.
The test substance was formulated as a suspension with Cremophor EL in sterile physiological saline solution (2% v/v). After the challenge with the 50% and 25% test substance concentration, neither the control animals nor the animals of the test substance group exhibited any redness of the skin or formation of edema. Thus, the test substance does not have a skin sensitization potential under the test conditions of the maximization 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:
- August 24 - September 17, 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:
- adopted version 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed in 1994. The Test guideline (TG) for the determination of skin sensitization in the mouse, the LLNA (TG 429) was adopted in 2002.
- Specific details on test material used for the study:
- The stability and homogeneity of the test substance in the application formulations were confirmed analytically.
- Species:
- guinea pig
- Strain:
- other: Hsd/Win:DH
- Sex:
- male
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Cremophor EL in saline solution (2% v/v)
- Concentration / amount:
- intradermal induction: 5% (20 mg test substance/animal)
topical induction: 50% (250 mg test substance/animal)
Challenge: 50% (250 mg test substance/animal) and 25% (125 mg test substance/animal) - Day(s)/duration:
- 2d (48h)
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: Cremophor EL in saline solution (2% v/v)
- Concentration / amount:
- intradermal induction: 5% (20 mg test substance/animal)
topical induction: 50% (250 mg test substance/animal)
Challenge: 50% (250 mg test substance/animal) and 25% (125 mg test substance/animal) - Day(s)/duration:
- 1d (24h)
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- test group: 20 animals
control group: 10 animals - Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole formulated with physiological NaCl
- Positive control results:
- Reliability of the Method:
The reliability of the method of the maximization test was checked on male guinea pigs using 2-mercaptobenzothiazole formulated with physiological NaCl at the following concentrations: A 2.5% test substance concentration was used for intradermal induction, and a 40% concentration for topical induction.
After the first challenge with 40% and 12% test substance sample, respectively, 80% and 55% of the animals of the test substance group exhibited skin reactions. After the second challenge with 3% and 1% test substance sample, respectively, skin reactions were recorded for 15% of the animals of the test substance group, in each case. No skin redness occurred in the control groups after either challenge.
In a more recent study involving 2-mercaptobenzothiazole and at the same induction concentrations, 80% and 65% of the animals of the test substance group reacted to the first challenge with 40% and 25% test substance sample, respectively; 80% and 75% of the animals of the test substance group exhibited a reaction after the second challenge with 12% and 6% test substance sample, respectively; no skin redness was observed in the control groups.
Both studies thus confirm the sensitivity and reliability of the method of the maximization test. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- After the second induction, a few animals of the test substance group exhibited incrustations or skin flaking in the treated areas.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- After the second induction, a few animals of the test substance group exhibited incrustations or skin flaking in the treated areas.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0.5 mL Cremophor EL in sterile physiological saline solution (2% v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- After the second induction, open wounds followed by incrustations or skin flaking in the treated
areas were observed on a few animals of the control group. - Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 mL Cremophor EL in sterile physiological saline solution (2% v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- After the second induction, open wounds followed by incrustations or skin flaking in the treated
areas were observed on a few animals of the control group. - Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- After the second induction, a few animals of the test substance group exhibited incrustations or skin flaking in the treated areas.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- After the second induction, a few animals of the test substance group exhibited incrustations or skin flaking in the treated areas.
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FOE 5043-hydroxy does not have a skin sensitization potential under the test conditions of the maximization test.
- Executive summary:
Using the maximization test of MAGNUSSON and KLIGMAN, the test substance was tested on male guinea pigs to determine whether it has skin sensitizing properties.
The following test substance concentrations were used in the test: Intradermal induction: 5%; Topical induction: 50%; Challenge: 50% and 25%.
The test substance was formulated as a suspension with Cremophor EL in sterile physiological saline solution (2% v/v). After the challenge with the 50% and 25% test substance concentration, neither the control animals nor the animals of the test substance group exhibited any redness of the skin or formation of edema. Thus, the test substance does not have a skin sensitization potential under the test conditions of the maximization test.
Reference
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
Based on the study results for skin sensitization no classification according to Regulation (EC) No. 1272/2008 (CLP), ANNEX I, is warranted.
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