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EC number: 217-707-7 | CAS number: 1937-19-5
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- study conducted on the analogue substance; The Reliability of the Source Study is 1.
- Justification for type of information:
- The read across justification is detailed in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Old studies NON LLNA available
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: HsdWin:DH
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 316-406 g
- Housing: 2-3 per cage throughout the study
- Diet ad libitum
- Water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 40-70
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5 %
- Day(s)/duration:
- one injection
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 50 %
- Day(s)/duration:
- 48 h
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 50 % and 25 %
- Day(s)/duration:
- after three weeks for 24 h
- No.:
- #2
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 50 % and 25 %
- Day(s)/duration:
- after four weeks for 24 h
- No. of animals per dose:
- 20
- Details on study design:
- Test Substance Formulation
Prior to each treatment the test substance was formulated (w/v) in sterile physiological saline solution to yield a suspension.
The formulations were continuously homogenized on a magnetic stirrer during the treatments.
The stability and homogeneity of the test substance in the formulations were analytically.
Three groups of animals were allocated by random selection to the main study: one test substance group consisting of 20 experimental animals (nos. 21 - 40), and two control groups made up of 10 animals each (nos. 1 - 10 and 11 -20). The second control group was held in reserve in case a second challenge might be necessary to check any ambiguous results from the first challenge, or to investigate concentration relationships if the first challenge produced positive results. The randomization list was generated on an IBM computer system using the Randu subroutine from IBM Scientific Subroutine Package.
The animals were identified using cage cards specifying the test substance, study number, animal number, dose and sex, and by individual markings using aqueous picric acid solution.
Dose Selection
The doses for the induction and challenge treatments were selected on the basis of the results of the dose range-finding studies. The selection of doses for the second challenge exposure was based on the results of the 1st challenge. - Challenge controls:
- The animal of the control groups were treated in the same manner as the animals of the test substance group; however, the formulations did not contain any test substance but a corresponding amount of sterile physiological saline.
- Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole formulated with physiological NaCl
Results and discussion
- Positive control results:
- After the 1st challenge with a 40% and 12% test substance formulation 80% and 55% of the test animals exhibited dermal alterations. After the 2nd challenge both with 3% and 1% test substance formulations 15 % of the test animals developed dermal signs. There was no reddening of the skin to be observed on control group animals.
In another test series with 2-mercaptobenzothiazole and the Same induction concentrations 80% and 65% of the test animals showed reactions to the 1st challenge using 40% and 25% test substance formulations, and 80% and 75% of the animals to the 2nd challenge using 12% and 6% concentrations, while the control group animals exhibited no skin redness.
The sensitivity as well as the reliability of the maximization test method is thus confirmed by both studies.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Reading:
- other: 1st and 2nd readings after challenge and rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
Any other information on results incl. tables
Since the test substance was found not to cause a primary skin irritation in the dose range-finding study, the treated areas of the animals were irritated with sodium lauryl sulfate prior to the topical induction.
After the 2nd induction some animals of the first control and test substance group showed encrustations in places on the treatment areas.
After the 1st challenge, 4 (20%) and 8 (40%) of the test substance animals responded with "very mild" (barely visible) redness to the 50% and 25% test substance formulation. Skin reddenings were not found in the control group animals.
After the 2nd challenge, 14 (70%) and 9 (45%) of the test substance animals responded with "very mild" (barely visible) to readily visiblew redness to the 50% and 25% test substance formulation. Skin reddenings were not found in the control group animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: Classified according to the CLP Regulation (EC) no.1272/2008 Skin sens. Cat. 1B
- Conclusions:
- The substance has sensitising properties.
- Executive summary:
The maximization test of Magnusson and Kligman was performed on male guinea pigs to determine whether test item exhibits skin sensitization properties.
This GLP study was performed according to OECD Guideline No. 406. The study was conducted with the following test concentrations:
intradermal induction: 5%
topical induction: 50 %
first challenge: 50 and 25 %
second challenge: 50 and 25 %
formulated in sterile physiological saline solution to yield a suspension.
After the first challenge the 50 % and 25% formulations led to skin redness in 20 % and 40 % of the test animals respectively. There were no skin reactions in the control group.
After the second challenge the 50 % and 25 % formulations led to skin redness in 70 % and 45 % of the test animals, respectively. There were no skin reactions in the control group.
Therefore, the test item exhibits a definitive skin-sensitization potential under the conditions of the maximization test.
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