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EC number: 465-100-2 | 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:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- The "maximisation test" of B. Magnusson and A. M.Kligman modified according to Maurer & Hess al was performed to reveal a possible sensitising potential of "STl571 F8".
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA method was not available yet at the time the study was conducted.
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- Batch number: 022401
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
Age of the animals: Approx. 5 - 7 weeks at the firs1 application.
Weight range of the animals at the first application: 281 g to 341 g.
Number of the animals in the main study: 10 animals for the test substance group 5 animals for the control group.
Hygiene:
Optimal hygienic conditions.
Room number:
EH1-21.
Room temperature:
Average of 21.9 °C (continuous control and recording).
Relative humidity: Average of 48.6 % (continuous control and recording).
Air exchange: Approx. 12/h.
Light: Only artificial light from 6.00 a.m. to 6.00 p.m.
Cages: Until Day 0: Makrolon cages type Ill (23 cm x 39 cm bottom area, 18 cm height) with wire mesh lids, single caging.
From Day O: group cagirg in plastic containers (46 cm x 105 cm x 36 cm), partly shaded, 6 (control group) or 11 (test substance group) animals per contcliner.
Feed: Altromin Maintenance Diet No. 3122, rich in crude fiber, ad libitum, offered in stainless steel containers. Analysis of the feed for ingredients and contclminants are performed randomly by
Altromin GmbH, D-32791 Lage.
Bedding material: Wood chips (aspen) from Fa. ABEDD Dominik Mayr KEG,
A-8580 Koflach. Reduction of microorganisms by autoclaving.
Water: Tap water offered in Makrolon bottles with stainless steel canules ad libitum.
Identification of the animals: Numbers tattooed in the pinna of the right ear.
Acclimatisation: 5 days.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 50% (w/w)in white petrolatum for the second induction exposure)
About 0.5 g of test substance formulation or of white petrolatum were applied to each animal. - Day(s)/duration:
- 7-9
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Remarks:
- 50% (w/w) in white petrolatum
- Concentration / amount:
- intradermal injections of FCA (to e,nhance a possible sensitisation) and immediately afterwards epicutaneous application of the, test substance to the sites of the intradermal injections. Application site was an area of approx. 2 cm x 4 cm in the interscapular region.
- Day(s)/duration:
- 0-1
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 50 % in white petrolatum. About 0.5 g of test substance formulation or of white petrolatum were applied to each animal.
- Day(s)/duration:
- 24
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Details on study design:
- According to the Guidelines, the concentrations of the test substance used for each induction exposure should be well-tolerated systemically and should be the highest to cause mild-to moderate skin irritation. The concentration used for the challenge exposure should be the highest non irritant one. To obtain the appropriate concentrations of the test substance for the definitive study, a preliminary test was carried out with 3 female guinea pigs. FCA was administered intradermally and immediately afterwards the test substance (50 % in white petrolatum, w/w)
was applied epicutaneously to the sites of the intrade1-mal injections to examine possible systemic toxic effects.
8 days later 4 concentrations of the test substance wme administered epicutaneously to the flanks of the animals. The modes of application were the same as in the de-'initive study. The duration of the epicutaneous exposure was 24 hours. The test substance was incorporated in white petrolatum. A test substance concentration of 50 % (w/w) in white petrolatum was the highest technically feasible concentration.
For the main study the following concentrations of "STl571 F8" were therefore selected:
50 % (w/w) in white petrolatum for the first and the se,cond epicutaneous induction and 25 % (w/w) in white petrolatum for the ctlallenge exposure.
As the highest technically feasible test substance concentration of 50 % in white petrolatum did not cause markable skin irritations it was also decided to pretreat all animals of both groups with a formulation of n-dodecylsulfate, sodium salt, in white petrolatum, one day before the second epicutaneous induction exposure.
Day 0 was 11 February 2003.
Day O: removal of hair, recording of body weight, intradermal FCA administration and epicutaneous administration of the test substancH.
Day 1: end of epicutaneous induction exposure.
Day 2: skin examination.
Day 6: removal of hair, treatment with n-dodecylsulfate, sodium salt.
Day 7: epicutaneous induction exposure.
Day 9: end of the epicutaneous induction exposure.
Day 1O: skin examination.
Day 21: removal of hair, epicutaneous challenge exposure
Day 21: end of the epicutaneous challenge period.
Day 23: approximately 21 hours after removing the patch cleaning of the challenge area,
approximately 3 hours later skin examination.
Day 24: skin examination, recording of body weight, sacrifice of animals, end of test.
All animals were observed once daily for behavioural channes or signs of toxicity.
The body weight of each animal was recorded on Days 0 and 24.
The application sites were examined 24 hours after the encl of the first epicutaneous induction exposure, 24 hours after the end of the second epicutaneous induction exposure and 24 and 48 hours after the end of the epicutaneous challenge exposure (blind reading of test and control animals).
A skin reaction after the challenge exposure was regarded as positive when the site, where test substance formulation was applied, was more irritated than the area of the site, where the vehicle was applied. The rate of these positively reactir g animals in the test substance group minus the rate of positively reacting animals in the negative control group gave the net percentage of sensitised animals.
The t-test was used to evaluate differences of the mean body weights between the test substance group and the control group on Days O and 24 ( p= 0.05). - Challenge controls:
- The application sites were examined 24 hours after the encl of the first epicutaneous induction exposure, 24 hours after the end of the second epicutaneous induction exposure and 24 and 48 hours after the end of the epicutaneous challenge exposure (blind reading of test and control animals).
- Positive control substance(s):
- yes
- Remarks:
- HEXYL CINNAMIC ALDEHYDE" (HCA)
Results and discussion
- Positive control results:
- Vehicle site: no positive skin reaction in any anima at any reading time.
Substance site: very slight to severe erythema and/or oedema in 7/1O animals 24 and/or 48 hours after the challenge exposure.
7/1O animals had a "positive skin reaction".
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% in white petrolatum
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- All animals of both groups had severe erythema and edema in the interscapular region (score "3"), which were attributed to the effects of the adjuvant.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% in white petrolatum
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- 24 and/or 48 hours after the end of the challenge exposure 10/1O test substance group animals had very slight to severe erythema and/or oedema at the test substance treated sites, attended by eschars in 3/10 animals.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% in white petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no positive skin reaction in any anima at any reading time. No animal had a "positive skin reaction".
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50% in white petrolatum
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- very slight to severe erythema and/or oedema in 7/1O animals 24 and/or 48 hours after the challenge exposure.
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 50 %
Signs of irritation during induction:
Severe erythema and oedema were observed at the induction
site.
Evidence of sensitisation of each challenge concentration:
Test substance group: 10/10 animals (100 %) had very slight
to severe erythema and/or oedema 24 and 48 hours after the
end of the challenge exposure, attended by eschars in
3/10 animals.
Negative control group: No positive skin reaction in any
animal at any reading time.
Other observations:
No relevant toxic signs other than local effects were
observed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- STI571 F8 is a skin sensitizer: Cat.1
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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