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EC number: 228-940-9 | CAS number: 6375-55-9
- 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
Sensitising
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:
- From May 30 to December 09, 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Magnusson B. - Kligman A. - The identification of contact allergens by animal assay. "The guinea pig maximization test". J. Invest. Dermatol 1969, 52, 3, 268-276.
- Version / remarks:
- 1969
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A LLNA study has not been conducted because adequate data from guinea pig Maximisation test study are already available.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Iffa-Credo (69210 Saint Germain sur l'Arbresle, France)
- Weight at study initiation: mean bodyweight of animals in the control group was 617 ± 29 g for males and 526 ± 35 g for females. The mean bodyweight of animals in the treated group was 622 ± 28 g for males and 544 ± 50 g for females.
- Housing: animals housed individually in polycarbonate preautoclaved cages (0.48 x 0.27 x 0.20 m) on sawdust (Sociêtê Parisienne des Sciures, 93500 Pantin, France).
- Diet (e.g. ad libitum): animals were fed ad libitum during the study, with a certified pelleted diet :Ref. 106 (U.A.R., Villemoisson sur Orge, France).
- Water (e.g. ad libitum): free access to bottles containing tap water filtered with Millipore filters (0.22 micron). Routine bacteriological and chemical analysis of water were made,
in order to detect major contaminants, by the Laboratoire Municipal (76000 Rouen, France)
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 50 ± 20%.
- Air changes: the incoming non-recycled air was filtered with an absolute filter
- Photoperiod (hrs dark / hrs light): the light/dark cycle was 12 hours per day. - Route:
- intradermal and epicutaneous
- Vehicle:
- other: Distilled water, NaCl 0.9 %, Freund's complete adjuvant
- Concentration / amount:
- - for the intradermal route at a concentration of 1% in distilled water; - for the epicutaneous route and the challenge patch test, undiluted
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Distilled water, NaCl 0.9 %, Freund's complete adjuvant
- Concentration / amount:
- 0.5 g of the undiluted test sample and 0.5 ml of the vehicle
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- control group: 10 animals (5 males - 5 females).
treated group : 20 animals (10 males - 10 females). - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
The animals were clipped and shaved on the scapula before each treatment.
a. Intradermal route
On Day 1, 3 x 2 intradermal injections of 0.1 ml each were performed on the scapula on a surface area of 4 x 2 cm (one injection of each solution per flank).
(1). Treated group
• Freund's complete adjuvant at 50 % in saline (NaCl0.9 %).
• Test sample at the concentration of 1% in distilled water.
• A 50/50 (v/v) mixture of Freund's complete adjuvant diluted at 50 % in saline (NaCl0.9 %) and of test sample at the concentration previously determined.
(2). Control group
• Freund's complete adjuvant at 50 % in saline (NaCl0.9 %)
• Vehicle : distilled water
• A 50/50 (v/v) mixture of Freund's complete adjuvant diluted at 50 % (v/v) in saline (NaCl0.9 %) and vehicle.
b. Epicutaneous route
On Day 8 after shaving the animals, 0.5 ml of sodium lauryl sulfate diluted at 10% in codex vaseline was applied to the scapular region
to provoke a local irritation.
On Day 9 : application to the scapular region, under an occlusive patch, during 48 h, on the 6 injections sites (4 x 2 cm):
(1) In the treated group, 0.5 g of the undiluted test sample per animal : the test sample was first applied to a hydrophilic gauze moistened with 0.5 ml of distilled water.
(2) In the control group, 0.5 ml of the vehicle : distilled water
B. CHALLENGE EXPOSURE
At the end of the rest period (on Day 25), the flanks of the animals of all groups were clipped and shaved. On Day 26, occlusive patches were applied on a 4 cm2 square for 24 hours with 0.5 g of the undiluted test sample per animal on the right flank, and 0.5 ml of the vehicle, distilled water on the left flank. The patches were kept in place by a hypo-allergenic tape. - Positive control substance(s):
- not specified
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g of the undiluted test sample and 0.5 ml of the vehicle
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Interpretation of results:
- other: Category 1B (indication of skin sensitising potential) based oon Regulation 1272/2008
- Conclusions:
- Sensitising
- Executive summary:
Method
The sensitizing potential of the test substance was tested after intradermal injections and cutaneous applications in male and female albino guinea pigs, according to Magnusson B. - Kligman A. ( J. Invest. Dermatol 1969).
Results
The intradermal induction was performed at the concentration of 1 % in distilled water. The epicutaneous induction and the challenge patch test were performed with the undiluted test sample. The behaviour of the animals was not influenced by the treatment. 24 hours after patch removal, cutaneous reactions could not be detected because of the staining of the skin by the test sample. 48 hours after patch removal, a slight erythema was observed on the right flank of five animals, and a well-defined erythema in one female. Skin samples were taken and subjected to microscopic examination. Histological evidence of a sensitization reaction due to the test sample was observed in eight animals.
Conclusion
Sensitising.
Reference
CLINICAL EXAMINATION
1. Behaviour and clinical signs
Neither change in behaviour nor clinical signs because of treatment were observed during the study period.
2. Mortality
No mortality was recorded during the study.
MACROSCOPIC CUTANEOUS REACTIONS AFTER THE CHALLENGE PATCH TEST
In the control group:
No cutaneous reactions were observed at each scoring.
In the treated group:
- 24 hours after patch removal, erythema could not be detected because of the staining of the skin by the test sample. No oedema was observed.
- 48 hours after patch removal , a skin dryness was observed on the right flank of one male (184). A very slight erythema was observed on the right flank of three males (187, 189, 190) and two females (196, 197). A well-defined erythema was observed on the right flank of one female (200). No cutaneous reactions were observed on the left flank (vehicle).
MICROSCOPIC EXAMINATIONS
- several animals showed, on either flank, some cutaneous reactions attributed to irritation
- 8 animals out of 20 in Group II showed cutaneous reactions on their right side of a type and severity that were attributed to a sensitization reaction (184, 187, 189, 190,194, 196, 197, 299)
- 2 animals out of 20 in group II showed equivocal cutaneous reactions on both sides (185 and 200).
There was no trace of the dye staining the surface of the treated skin after processing techniques.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
- Additional information:
The sensitizing potential of the test substance was tested after intradermal injections and cutaneous applications in male and female albino guinea pigs, according to Magnusson B. - Kligman A. ( J. Invest. Dermatol 1969).
The intradermal induction was performed at the concentration of 1 % in distilled water. The epicutaneous induction and the challenge patch test were performed with the undiluted test sample. The behaviour of the animals was not influenced by the treatment. 24 hours after patch removal, cutaneous reactions could not be detected because of the staining of the skin by the test sample. 48 hours after patch removal, a slight erythema was observed on the right flank of five animals, and a well-defined erythema in one female. Skin samples were taken and subjected to microscopic examination. Histological evidence of a sensitization reaction due to the test sample was observed in eight animals.
Justification for classification or non-classification
SKIN SENSITIZATION
Category 1
Substances shall be classified as skin sensitizers in Category 1 where data are not sufficient for sub-categorisation in accordance with the following criteria:
(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or
(b) if there are positive results from an appropriate animal test.
Specific criteria of animal test:
when an adjuvant type test method for skin sensitisation is used, a response of at least 30 % of the animals is considered as positive.
For a non-adjuvant Guinea pig test method a response of at least 15 % of the animals is considered positive.
Furthermore, stimulation index of three or more is considered a positive response in the local lymph node assay.
Sub-category 1A
Substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have the potential to produce significant sensitisation in humans. Severity of reaction may also be considered.
Specific criteria:
Local lymph node assay-EC3 value ≤ 2 %
Guinea pig maximisation test-≥ 30 % responding at ≤ 0,1 % intradermal induction dose or ≥ 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose
Buehler assay - ≥ 15 % responding at ≤ 0,2 % topical induction dose or ≥ 60 % responding at > 0,2 % to ≤ 20 % topical induction dose
Sub-category 1B
Substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals can be presumed to have the potential to produce sensitisation in humans. Severity of reaction may also be considered.
Local lymph node assay - EC3 value > 2 %
Guinea pig maximisation test- ≥ 30 % to < 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose or ≥ 30 % responding at > 1 % intradermal induction dose.
Buehler assay - ≥ 15 % to < 60 % responding at > 0,2 % to ≤ 20 % topical induction dose or ≥ 15 % responding at > 20 % topical induction dose.
Based on the results of the animal test (Guinea pig maximisation test) performed, according to the paragraph 3.4. of the CLP Regulation n. 1272/2008, the test substance is classified in SubCategory 1B, as 40 % of the animals were positive after treatment (intradermal dose = 1 % of test substance).
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