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EC number: 419-740-4 | CAS number: 137658-79-8 CGL 1545
- 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
To assess the allergenic potential of the test article in albino guinea pigs the Maximization-Test (OECD guideline 406) was conducted.
None of the animals of the test group were observed with positive skin reactions after treatment with a non-irritant test substance concentration of 50 % in PEG 400. No skin reactions were observed in the control group. Therefore the test article is considered to be a non-sensitizer when described under the test conditions.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 17 Jul 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA method was not available yet by the time the study was conducted. Moreover, an appropriate guinea pig maximisation test is available which would not justify conducting an additional LLNA due to animal welfare.
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: Z 2651-01
- Purity: > 95%
- Expiration date: Feb 1997
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the original container at room temperature (approx. 20°C), away from direct sunlight
- Stability under test conditions: Stable under storage condition
- Solubility and stability of the test substance in the solvent/vehicle: Unknown in PEG 400 and in a 1:1 (v/v) mixture of FCA/ physiological saline, is excluded from the statement of compliance
FORM AS APPLIED IN THE TEST (if different from that of starting material): Solution
OTHER SPECIFICS:
- Description: Yellowish solid - Species:
- guinea pig
- Strain:
- other: Ibm: GOHI; SPF-quality guinea pigs (synonym: Himalayan spotted) delivered by BRL
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Strain: Ibm: GOHI; SPF-quality guinea pigs (synonym: Himalayan spotted) delivered by BRL
- Source: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4, 4414 Fullinsdorf/Switzerland
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 317 - 428 g
- Housing: Individually in Makrolon type-3 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
- Diet (e.g. ad libitum): Pelleted standard Kliba 342, Batch no. 68/95 guinea pig breeding/maintenance diet ("Kliba", Klingentalmuhle AG, CH-4303 Kaiseraugst), ad libitum
- Water (e.g. ad libitum): Community tap water, ad libitum. Once weekly additional supply of ascorbic acid (1 g/l) via the drinking water
- Acclimation period: One week for the control and test group under test conditions after health examination. No acclimatization for the animals of the pretest. Only animals without any visual signs of illness were used for the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES:
Treatment / Observation: 22-MAY-1995 to termination
Termination: 15-JUN-1995 - Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Remarks:
- The 1:1 mixture (v/v) of Freund's Complete Adjuvant:physiological saline was used as a vehicle for the intradermal induction in the main study.
- Concentration / amount:
- induction intradermal: 1% solution with PEG 400 and 1:1 mix with Freund`s solution
induction epidermal: 50% in PEG 400
injection of 0.1 ml/site - Day(s)/duration:
- epidermal: 48 h
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- The 1:1 mixture (v/v) of Freund's Complete Adjuvant:physiological saline was used as a vehicle for the intradermal induction in the main study.
- Concentration / amount:
- 50 % in PEG 400
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Control Group 10
Test Group 20
Intradermal Pretest 2
Epidermal Pretest 4 - Details on study design:
- RANGE FINDING TESTS:
performed during the acclimatization period to identify a maximally tolerated concentration of the test article suitable for the induction phase of the main study.
In addition, a suitable non-irritant concentration of the test article, by the topical route of administration, was identified for the challenge application.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three pairs of intradermal injections (0.1 ml/site) day 1, epidermal induction day 8
- Exposure period: epidermal 48 h
- Test groups: 20
- Control group: 10
- Frequency of applications: single
- Concentrations: see above
test area was pretreated with 10% Sodium-Lauryl-Sulfate (SLS) in paraffinum perliquidum as no primary irritation had been observed in the pretest
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 22
- Exposure period: 24 h
- Test groups: 20
- Control group: 10
- Concentrations: see above
- Evaluation (hr after challenge): after 24 and 48h, epilation cream used before
Scoring system:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area
well-defined by definite raising) 2
Moderate oedema (raised approximately
1 millimeter) 3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure) 4 - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazol
- Positive control results:
- In this study 95% and 90% of the animals of the test group were observed with positive skin reactions at the 24- and 48-hour reading respectively after treatment with a non-irritant test substance concentration of 5% in peanut oil.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- A slight yellow discolouration was noted after removal of the dressing
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- A slight yellow discolouration was noted after removal of the dressing
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study (according OECD guideline 406) none of the animals of the test group were observed with positive skin reactions after treatment with a non-irritant test substance concentration of 50% in PEG 400. No skin reactions were observed in the control group. Therefore, the test article at a concentration of 50 % in PEG 400 is considered to be a non-sensitizer when described under the test conditions.
- Executive summary:
To assess the allergenic potential of the test article in albino guinea pigs the Maximization-Test according to a GLP-compliant OECD guideline 406 was used. Ten females were used as control group and 20 females were used as test group. The highest non-irritating test article concentration used for challenge application was 50 % in PEG 400.
None of the animals showed any treatment related skin reactions. Neither toxic symptoms nor deaths occurred in the control and test groups.
Reference
- No toxic symptoms were evident in the guinea pigs of the control or test group
- No deaths occurred in the control and test groups
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
To assess the allergenic potential of the test article in albino guinea pigs the Maximization-Test (OECD guideline 406) was conducted. Ten female animals were used as control group and 20 females were used as test group. After intradermal and epicutaneously induction, the animals were challenged epicutaneous with a 50 % solution of the substance in PEG 400. Evaluation and scoring of the reactions followed after 24h and 48h. Positive controls were performed with 2 -Mercaptobenzothiazol.
None of the animals showed erythema or oedema after treatment with the test article. Neither toxic symptoms nor deaths occurred in the control and test groups.
Multiple application of the test substance onto skin did not cause an allergic reaction. Therefore, the test substance is considered to be a non-sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Sensitisation after inhalation of the test substance was not investigated. The major part of the substance has a particle size of > 40µm (92 %) or more. Inhalable particles of < 10 or < 4 µm are not included. As the substance has a very low vapour pressure, inhalation exposure is not relevant.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No local reactions were observed in a guinea pig maximization test (OECD 406) after induction. Therefore, the substance does not require classification as a skin sensitizer under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EC) No 2018/1480.
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