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EC number: 432-070-7 | CAS number: -
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 1997 - July 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Planning and conduct of the study were based on the guidance provide by the following guidelines and directives: EEC Directive 96/54, L248, Annex IV C, Test B.6 (dated September 30, 1996) EEC Directive 93/21, L 110 A, Annex IV (dated May 04, 1993) OECD guidelines for the testing of chemicals (guideline 406 adopted July 17, 1992)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was already available.
Test material
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld
- Age at study initiation: approx. 28 days
- Weight at study initiation: 287 +/-10 g (n=15)
- Housing: Altromin Type S8/15, granulated soft wood bedding (Altromin, 32791 Lage/Lippe, Germany) Batch No. 051297 until 17/12/97, thereafter 181297
- Diet (ad libitum): Altromin 1322, standard diet for guinea pigs, Batch No: 040398/0725
- Water (ad libitum): tap water (municipal supply Bitterfeld) in Makrolon bottles, daily change
- Acclimation period: 6 days before the start of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23°C
- Humidity (%):30-60%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): artificial ligth is set to give a cycle of 12 hours light and 12 hours dark
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- INDUCTION EXPOSURE:
Day 0: Induction by intradermal injection: Two pairs of intradermal injections of 0.1 ml each were administered to each animal.
Control group:
Injection 1: 50:50 mixture (v/v) of FCA and Aqua pro injectione
Injection 2: Aqua pro injectione
Injection 3: the third injection was not necessary because the chosen vehicle was Aqua pro injectione
Dose group:
Injection 1: 50:50 mixture (v/v) of FCA and Aqua pro injectione
Injection 2: 10% solution (w/v) of the test article in Aqua pro injectione
Injection 3: 10% emulsion (w/v) of the test article in 50:50 mixture (v/v) Aqua pro injectione and FCA
Day 7: Induction by dermal application
Control group: Filter papers (2x4 cm) were soaked in 0.1 g of white vaseline. One paper each was then placed on the skin on both sides of the body and covered with an occlusive dressing for 48 hours.
Dose group:
Filter papers (2x4 cm) were soaked in 0.1 g of the 75:25 mixture (w/w) of test article and white vaseline. One paper each was then placed on the skin on both sides of the body and covered with an occlusive dressing for 48 hours.
CHALLENGE EXPOSURE:
Day 21: Challenge by dermal application: each animal: 1.0 g sample of either vehicle or the 75:25 mixture (w/w) of test article and white vaseline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- INDUCTION EXPOSURE:
Day 0: Induction by intradermal injection: Two pairs of intradermal injections of 0.1 ml each were administered to each animal.
Control group:
Injection 1: 50:50 mixture (v/v) of FCA and Aqua pro injectione
Injection 2: Aqua pro injectione
Injection 3: the third injection was not necessary because the chosen vehicle was Aqua pro injectione
Dose group:
Injection 1: 50:50 mixture (v/v) of FCA and Aqua pro injectione
Injection 2: 10% solution (w/v) of the test article in Aqua pro injectione
Injection 3: 10% emulsion (w/v) of the test article in 50:50 mixture (v/v) Aqua pro injectione and FCA
Day 7: Induction by dermal application
Control group: Filter papers (2x4 cm) were soaked in 0.1 g of white vaseline. One paper each was then placed on the skin on both sides of the body and covered with an occlusive dressing for 48 hours.
Dose group:
Filter papers (2x4 cm) were soaked in 0.1 g of the 75:25 mixture (w/w) of test article and white vaseline. One paper each was then placed on the skin on both sides of the body and covered with an occlusive dressing for 48 hours.
CHALLENGE EXPOSURE:
Day 21: Challenge by dermal application: each animal: 1.0 g sample of either vehicle or the 75:25 mixture (w/w) of test article and white vaseline
- No. of animals per dose:
- 10 males (test group)
5 males (control group) - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
Induction by intradermal injection (Day 0)
- No. of exposures: 3
- Exposure period: -
- Test groups:
Injection 1: 50:50 mixture (v/v) of FCA and Aqua pro injectione
Injection 2: 10% solution (w/v) of the test article in Aqua pro injectione
Injection 3: 10% emulsion (w/v) of the test article in 50:50 mixture (v/v) Aqua pro injectione and FCA
- Control group:
Injection 1: 50:50 mixture (v/v) of FCA and Aqua pro injectione
Injection 2: Aqua pro injectione
Injection 3: the third injection was not necessary because the chosen vehicle was Aqua pro injectione
- Site: shoulder region, each side of the midline in cranial to caudal sequence
- Frequency of applications:
- Duration:
- Concentrations:
Induction by dermal application (Day 7)
Dose group:
Filter papers (2x4 cm) were soaked in 0.1 g of the 75:25 mixture (w/w) of test article and white vaseline. One paper each was then placed on the skin on both sides of the body and covered with an occlusive dressing for 48 hours.
Control group: Filter papers (2x4 cm) were soaked in 0.1 g of white vaseline. One paper each was then placed on the skin on both sides of the body and covered with an occlusive dressing for 48 hours.
B. CHALLENGE EXPOSURE
Challenge by dermal application (Day 21)
each animal: 1.0 g sample of either vehicle or the 75:25 mixture (w/w) of test article and white vaseline
- No. of exposures: each animal
- Day(s) of challenge: 21
- Exposure period: 24 hours
- Test groups: 1.0 g sample of either vehicle or the 75:25 mixture (w/w) of test article and white vaseline
- Control group: 1.0 g sample of either vehicle or the 75:25 mixture (w/w) of test article and white vaseline
- Site:dose group: right flank, controll group: left flank
- Concentrations: either vehicle or the 75:25 mixture (w/w) of test article and white vaseline
- Evaluation: 24 and 48 hours after patch removal (Days 23 and 24) - Challenge controls:
- Guidelines recommend the use of guinea-pigs as the experimental rodent species for this type of study. The guinea-pig has been the mammal of choice for predictive sensitisation tests for several decades and a considerable data base is availabel from the literature.
- Positive control substance(s):
- yes
- Remarks:
- Freund's Complete Adjuvant (FCA)
Results and discussion
- Positive control results:
- The positive control results demonstrate that the laboratory has the capability to identify positive dermal sensitizers.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle (vaseline)
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- vehicle (vaseline)
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- test item in vaseline (75:25)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- test item in vaseline (75:25)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Group:
- positive control
- Remarks on result:
- other: no positive control was conducted
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- According to the classification system for skin reactions of the EEC Directive 93/21 Brüggolit FF6 has no skin sensitisation effect.
- Executive summary:
The skin sensitisation potential of the test article was investigated in the Guinea-pig Maximisation Test with the Dunkin Hartley albino strain, whose sensitivity to benzocaine has been demonstrated.
In the course of testing, no clinical signs were observed and the body weight gain of animals was not significantly influenced. The choice of doses was based on the results ofthe pilot study.
The animals showed a very homogeneous reaction to the application of the test substance.
The intradermal injection of the 10 % solution of the test article alone and in combination with sensitisation potentiating FCA lead to slight erythema and oedema.
The same pattern was seen at injection site 1 (FCA/water mixture ) in the control animals. Topical induction was attempted with the 75:25 mixture of test article with white vaseline on day 7.
After removal of the occlusive dressing on day 9 not any skin irritation was recorded in the animals.
After challenge with the 75:25 preparation in white vaseline neither the control nor the dose group animals showed any skin effects. Oedema formation was excluded by measurement of skin-fold thickness.
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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