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EC number: 428-410-9 | CAS number: 67014-36-2
- 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
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:
- 1998-04-28 - 1998-05-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Source : Charles River, Germany
- Age at study initiation: approx. 5 weeks
- Weight at study initiation: < 500 g
- Housing: Group-housing of 5 animals
- Diet: standard guinea pig diet, ad libitum (LC 23-B, pellet diameter 4mm)
- Water: tap water, ad libitum
- Acclimation period: at least 5 days before treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- Induction: 3 different injections
A) 1:1 w/w mixture of Freunds' Complete Adjuvant (Difco, Detroit, USA) with water for injection (Fresenius AG, Bad Homburg, Germany
B) The test substance at a 2% concentration
C) 1:1 w/w mixture of the test substance, at twice the concentration used in (B) and Freunds' Complete Adjuvant (4 animals) or separate injections of solutions A) and B) (0.05 ml each) given very close together (remaining animals)
Challenge: 50 % w/w in vehicle - Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- Induction: 3 different injections
A) 1:1 w/w mixture of Freunds' Complete Adjuvant (Difco, Detroit, USA) with water for injection (Fresenius AG, Bad Homburg, Germany
B) The test substance at a 2% concentration
C) 1:1 w/w mixture of the test substance, at twice the concentration used in (B) and Freunds' Complete Adjuvant (4 animals) or separate injections of solutions A) and B) (0.05 ml each) given very close together (remaining animals)
Challenge: 50 % w/w in vehicle - No. of animals per dose:
- 4 animals for irritation study
10 animals for induction and challenge study
5 animals for the control group - Details on study design:
- RANGE FINDING TESTS:
Prior to the start of the Main study, the intradermal and epidermal irritancy of the test substance was investigated to select test substance concentrations suitable for the induction and challenge phase of the Main Study. The test system, procedures and techniques were identical to those used during the main study, unless otherwise specified. The animals were selected from stock and were between 5 and 9 weeks old, and as a consequence the body weights could exceed 500 grams. Body weights were determined prior to treatment. A series of four test substance concentrations was used for Induction; the highest concentration being the maximum concentration that could technically be injected. Each of two animals received two different concentrations in duplicate (0.1 mL/site) in the clipped scapular region.
A series of four test substance concentrations was used; the highest concentration being the maximum concentration that could technically be applied. Two different concentrations were applied (0.5 mL each) per animal to the clipped flank, using Metalline patches (2x3 cm) mounted on Medical tape, which were held in place with Micropore tape' and subsequently Coban elastic bandage. The animals receiving intradermal injections were treated with the lowest concentrations and two further animals with the highest concentrations. After 24 hours, the dressing was removed and the skin cleaned of residual test substance.
The injection sites and treated skin areas were assessed for irritation 24 and 48 hours after treatment.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 injections
- Exposure period: 48 hours
- Test groups: 10 female animals
- Control group: 5 female animals
- Site: scapular region
- Duration: 21 days
- Concentrations:
A) 1:1 w/w mixture of Freunds' Complete Adjuvant (Difco, Detroit, USA) with water for injection (Fresenius AG, Bad Homburg, Germany
B) The test substance at a 2% concentration
C) 1:1 w/w mixture of the test substance, at twice the concentration used in (B) and Freunds' Complete Adjuvant (4 animals) or separate injections of solutions A) and B) (0.05 ml each) given very close together (remaining animals)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1 day
- Exposure period: 24 hours
- Test groups: 10 female animals
- Control group: 5 female animals
- Site: scapular region
- Concentrations: 50% in vehicle
- Evaluation (hr after challenge): 24 and 48 hours after removal of dressing - Challenge controls:
- The control groups were challenged in the way as the test animals.
- Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 8.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 9.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Preliminary Study
The necrosis seen at intradermal injection of the lower concentrations (2% and 1%) was considered to be caused mainly by the propylene glycol rather than the test substance. This is confirmed by the consistent diameter of the necrotic area seen in the control animals after the intradermal injection with propylene glycol only in the main study. Based on these results, the test substance concentrations selected for the Main Study were a 2% concentration for the intradermal induction and a 50% concentration for the epidermal induction exposure. No signs of irritation were observed to the highest test substance concentration tested in the preliminary irritation study. Therefore, the test site of all animals was treated with 10% SDS approximately 24 hours before the epidermal induction in the main study, to provoke a mild inflammatory reaction. A 50% test substance concentration was selected for the challenge phase.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A skin sensitisation study was conducted according to OECD guideline 406 and EU method B.6. Test substance concentrations selected for the Main study were based on the results of a preliminary study. In the Main study, ten experimental animals were intradermally injected with a 2% concentration and epidermally exposed to a 50% concentration. Five control animals were similarly treated, but with the vehicle (Propylene glycol) only. Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all animals were challenged with a 50% test substance concentration and the vehicle. In the challenge phase, skin reactions varying between grades 1 and 3, were observed in nine experimental animals in response to the 50% test substance concentration. Scaliness or eschar formation were seen in some treated skin sites among the experimental animals, 48 hours after the challenge exposure. No skin reactions were evident in the control animals. The skin reactions observed in response to a 50% test substance concentration in nine (out of ten) experimental animals in the challenge phase were considered indicative of sensitisation. based on the absence of any response in the control animals. These results indicate a sensitisation rate of 90%. (NOTOX B.V., 1998)
Migrated from Short description of key information:
A dermal sensitisation study conducted according to OECD 406 in guinea pigs indicates that the test substance is a skin sensitiser.
Justification for selection of skin sensitisation endpoint:
GLP and guideline compliant study.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, the test item has to be classified and labelled as category 1 (H317: May cause an allergic skin reaction) according to Regulation (EC) No 1272/2008 (CLP) and as Xi, R43 (May cause sensitisation by skin contact) according to Directive 67/548/EEC (DSD).
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