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EC number: 276-558-6 | CAS number: 72275-69-5
- 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
Endpoint summary
Administrative data
Description of key information
The test article is considered as not sensitiser.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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:
- From March 28, 1994 to June 23, 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline 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
- Justification for non-LLNA method:
- A LLNA skin sensitisation study does not need to be conducted because adequate data from an other in vivo skin sensitisation study is available
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production
- Weight at study initiation: 338 to 421 g.
- Housing: The animals were housed individually in Macrolon cages (Type 3)
- Diet: The animals received ad libitum standard guinea pig pellets NAFAG No. 845
- Water: ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 to 70 %
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light - Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Test group:
- adjuvant/saline mixture 1:1 (v/v)
- 5 % in physiological saline (w/v)
- 5 % in the adjuvant/saline mixture (w/v)
Control group:
- adjuvant/saline mixture 1:1 (v/v)
- adjuvant/saline mixture 1:1 (v/v)
- physiological saline - Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Test group:
- adjuvant/saline mixture 1:1 (v/v)
- 5 % in physiological saline (w/v)
- 5 % in the adjuvant/saline mixture (w/v)
Control group:
- adjuvant/saline mixture 1:1 (v/v)
- adjuvant/saline mixture 1:1 (v/v)
- physiological saline - No. of animals per dose:
- PRETEST
test group
5 per sex doses
control group
5 X sex for controls.
MAIN TEST
test group
10 X sex X dose
cotrol group
5 X sex X dose - Details on study design:
- PRETESTS
INDUCTION EXPOSURE INTRADERMAL INJECTIONS
- Test groups: 5 guinea-pigs
- Concentrations: 5 % in physiological saline (w/v).
Since 5 % in physiological saline could be injected and was well tolerated, this concentration was used for the intradermal induction.
INDUCTION EXPOSURE: Epi dermal applications
- Exposure period:
- Test groups: 5 guinea pigs
- Concentrations:
A = 30 %
B = 50 %,
50% was the highest possible concentration of the test article in physiological saline.
The tested concentrations did not induce erythema reactions.
MAIN STUDY
A1. INDUCTION EXPOSURE:
- No. of exposures: Three pairs of intradermal injections (0.1 ml/site)
- Exposure period: performed on test day 0:
- Test groups: 20 guinea pig
- Control group: 10 guinea pig
- Site: left and right side of the shaved neck of the test and control group animals.
- Duration: Three pairs of intradermal injections
- Concentrations:
Test group:
- adjuvant/saline mixture 1:1 (v/v)
- 5 % in physiological saline (w/v)
- 5 % in the adjuvant/saline mixture (w/v)
Control group:
- adjuvant/saline mixture 1:1 (v/v)
- adjuvant/saline mixture 1:1 (v/v)
- physiological saline
A2. INDUCTION EXPOSURE: Epidermal applications
- No. of exposures: one patch
- Exposure period: performed on test day 8
- Test groups: 20 guinea pig
- Control group: 10 guinea pig
- Site: the neck of the animals (patch 2x4 cm; approx. 0.4 g per patch
- Duration: 48 hours
- Concentrations:
Test group:
- 50 % in physiological saline
Control group:
- physiological saline only
B. CHALLENGE EXPOSURE
- No. of exposures: one patch
- Day(s) of challenge: performed on test day 22
- Exposure period:24 hours
- Test groups: 20 guinea pig
- Control group: 10 guinea pig
- Site: tested on one flank (patch 2x2 cm; approx. 0.2 g per patch, occluded administration)
- Concentrations:
Test and control group:
- 50 % in physiological saline
- physiological saline only - Challenge controls:
- Induction reactions
The animals were pretreated with 10% sodium-laurylsulfate on day 7. - Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% in the adjuvant/saline mixture (w/v)
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- Erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% in the adjuvant/saline mixture (w/v). No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% in the adjuvant/saline mixture (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% in the adjuvant/saline mixture (w/v). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Interpretation of results:
- other: Not classified according to the CLP Regulation (EC n. 1272/2008)
- Conclusions:
- Not sensitizer
- Executive summary:
The substance was tested for skin sensitisation according The OECD 406 guideline and 92/69/EEC, B.6 method.
Under the experimental conditions employed, 5 % of the animals of the test group showed skin reactions 24 hours after removing the dressings.
Under the test condition, the substance does not show any sensitisation potential, therfore is considered to be non sensitizer.
Reference
Under the experimental conditions employed, 5 % of the animals of the test group showed skin reactions 24 hours after removing the dressings.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008), skin sensitiser means a substance that will lead to an allergic response following skin contact.
A test substance is assigned to:
Category 1A if positive results is observed in " ≥ 30 % responding at ≤ 0,1 % intradermal induction dose or ≥ 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose,"
or to
Category 1B if " ≥ 30 % to < 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose or ≥ 30 % responding at > 1 % intradermal induction dosein the guinea pig maximisation test.
The experiment conducted clearly shows that the substance is not capable to produce positive reactions after treatment with the highest non-irritant test substance concentration and no toxic symptoms were evident. The test article is considered to be a non sensitizer and no classification is warranted.
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