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EC number: 411-380-6 | CAS number: 147315-50-2 CG 30-1577
- 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 used. None of the animals showed erythema or oedema after multiple treatments with the test article. Therefore, the test substance is considered to be a non-sensitizer.
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:
- 1992-08-11 - 1992-11-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- 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:
- Currently no LLNA study is available for assessment. The GPMT has been carried out as an animal test to predict human sensitisation for over a decade and is recommended by international test guidelines such as OECD.
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production, Stein, Switzerland
- Age at study initiation: young adult based on body weight range
- Weight at study initiation: 334 to 414 g
- Housing: individually in Macrolon cages (Type 3)
- Diet: standard guinea pig pellets, ad libitum
- Water: fresh water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3 °C
- Humidity: 30 - 70 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 1992-09-07 To: 1992-10-08 - Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- Intradermal induction exposure: 5%
Epicutaneous induction and epicutaneous challenge exposure (based on pretest results): 40% - Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- Intradermal induction exposure: 5%
Epicutaneous induction and epicutaneous challenge exposure (based on pretest results): 40% - No. of animals per dose:
- Pretest: 6 animals (3 males, 3 females)
Main test: 20 test animals (10 males, 10 females), 10 control animals (5 males, 5 females), - Details on study design:
- RANGE FINDING TESTS:
A pretest was performed to identify appropriate test item concentrations for induction and challenge in the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 exposures, i.e. a single intradermal exposure in week 1 (6 injections/animal) and an epicutaneous exposure in week 2 (closed patch)
- Exposure period: single application (intradermal exposure), 48 hours (epicutaneous exposure)
- Test group: 1 group of 20 animals
- Control group: 1 group of 10 animals
- Site: neck region
- Frequency of applications: 1 intradermal application (week 1) and 1 epicutaneous application (week 2)
- Concentrations: 5 % (intradermal exposure), 40 % (epicutaneous exposure)
B. CHALLENGE EXPOSURE
- No. of exposures: 1 epicutaneous exposure
- Day of challenge: in week 5 of the study period
- Exposure period: 24 hours
- Test group: 1 group of 20 animals
- Control group: 1 group of 10 animals
- Site: neck region
- Concentration: 40 % (epicutaneous exposure)
- Evaluation: approximately 24 and 48 hours after removal of the dressing
OTHER:
No skin irritation was observed in the pretest. Therefore the application site was pretreated with 10 % sodium laurylsulfate (open application) 24 hours prior to the epidermal induction application. - Challenge controls:
- No evident positive reactions were noted after the first challenge application, neither when treated with vaseline alone nor when treated with a 40% test substance dilution.
- Positive control substance(s):
- yes
- Remarks:
- Potassiumdichromate, for the induction period a 0.20 % dilution in physiological saline (intradermal induction) and 5 % preparation in vaseline (for epidermal induction) was used. For the challenge procedure a 1 % preparation in vaseline was used.
- Positive control results:
- A positive control with a known sensitizer produced the expected rate of sensitization reactions and demonstrated the sensitivity of the test system.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 40 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 40 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Interpretation of results:
- GHS criteria not met
- Executive summary:
In a dermal sensitisation study with the test item (as described in section 1.2) in Oleum arachidis (intradermal induction) or in vaseline (epicutaneous applications), young adult guinea pigs (test group: 10 males and 10 females, control group: 5 males and 5 females) were tested using the guinea pig maximisation test of Magnusson and Kligman. In this study, the test group animals received 5 % of the test item for intradermal induction in week 1 as well as 40 % (highest non-irritant concentration) of the test item for epicutaneous induction in week 2 and challenge in week 5. Concurrent negative control animals were treated similarly, except that during the induction phase the test item was omitted. No animal of the test group was sensitised by the test item under the experimental condition employed. Under the conditions of this study, the test item was not a skin sensitiser.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Procedure and observations
To assess the allergenic potential of the test article in albino guinea pigs the Maximization-Test (OECD guideline 406) was used (Ciba 1992e). Ten animals per sex were used in the treatment group, five of each in the control group. After intradermal and epicutaneous induction, the animals were challenged epicutaneous with a 40% solution of the substance in petrolatum. Evaluation and scoring of the reactions followed after 24h and 48h. Positive controls were performed with potassium dichromate.
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.
Discussion
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
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008 (CLP)
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result, the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008.
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