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EC number: 230-072-0 | CAS number: 6938-94-9
- 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
The skin sensitization potential of test chemical was assessed in various experimental studies conducted on human subjects. The predicted data using the Danish QSAR database has also been compared with the experimental data. Based on the available data for the test chemical and supporting studies, it can be concluded that the test chemical is unable to cause skin sensitization and thus can be considered as not sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “non Skin 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from publication
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To determine skin sensitization potential of test chemical
- GLP compliance:
- not specified
- Type of study:
- other: Human Repeat Insult Patch Test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Human Repeat Insult Patch Test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD
- Species:
- other: Human
- Strain:
- other: not applicable
- Sex:
- male/female
- Details on test animals and environmental conditions:
- not specified
- Route:
- other: not specified
- Vehicle:
- not specified
- Concentration / amount:
- 3.0%
- Day(s)/duration:
- 24 h
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- other: not specified
- Vehicle:
- not specified
- Concentration / amount:
- 3.0 %
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 50 men and women
- Details on study design:
- Details on study design
RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:10
- Exposure period:24 h
- Test groups:55
- Control group: not specified
- Site:not specified
- Frequency of applications: not specified
- Duration: not specified
- Concentrations:3.0%
B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge:After 7 days of resting period,challenge patch was applied
- Exposure period:24 h
- Test groups:55
- Control group: not specified
- Site: not specified
- Concentrations:3.0%
- Evaluation (hr after challenge):24 and 48 h - Challenge controls:
- not specified
- Positive control substance(s):
- not specified
- Positive control results:
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3.0%
- No. with + reactions:
- 0
- Total no. in group:
- 50
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- Human Repeat Insult Patch Test was conducted on 50 male and female subjects to assess the skin sensitization potential of test chemical. A test was conducted using a suntan lotion containing
3.0% test chemical. During induction,10 patches were applied for exposure period of 24 hours. After a rest period of 7 days, a challenge patch was applied for exposure period of 24 hours.Observations were done after 24 and 48 hours. No skin sensitization reactions were produced in the 50 men and women panelists. Hence the test material was considered as not sensitizing to the human skin. - Executive summary:
Human Repeat Insult Patch Test was conducted on 50 male and female subjects to assess the skin sensitization potential of test chemical. A test was conducted using a suntan lotion containing 3.0% test chemical. During induction,10 patches were applied for exposure period of 24 hours. After a rest period of 7 days, a challenge patch was applied for exposure period of 24 hours.Observations were done after 24 and 48 hours. No skin sensitization reactions were produced in the 50 men and women panelists. Hence the test material was considered as not sensitizing to the human skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Various studies has been investigated for the test chemical to observe the potential for skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in human and guinea pigs for test chemical .The predicted data using the Danish QSAR database has also been compared with the experimental data and summarized as below:
Human Repeat Insult Patch Test was conducted on 50 male and female subjects to assess the skin sensitization potential of test chemical. A test was conducted using a suntan lotion containing 3.0% test chemical. During induction,10 patches were applied for exposure period of 24 hours. After a rest period of 7 days, a challenge patch was applied for exposure period of 24 hours.Observations were done after 24 and 48 hours. No skin sensitization reactions were produced in the 50 men and women panelists. Hence the test material was considered as not sensitizing to the human skin.
The above study was supported by Kligman maximization test was conducted on 25 male and female subjects to assess the contact sensitization potential of test chemical. A test was conducted using a facial cream containing 0.7% test chemical. The material was applied under occlusion to the skin of the volar forearm or back of 25 subjects for five consecutive 48 h periods. The patch site was then treated with 2.5% sodium lauryl sulfate for 24 h under occlusion. A challenge patch was then applied for 48 h and the site read immediately after patch removal and 24 h later. No contact sensitization reactions were produced in the 25 subjects. Hence the test material was considered as not sensitizing to the human skin.
Furthermore, Human Repeat Insult Patch Test was conducted on 116 male and female subjects to assess the skin sensitization potential of test chemical.The test chemical was applied dermally to the skin of human volunteers at a dose of 1.04% (0.1 ml).During induction,9 patches were applied for exposure period of 24 hours. After a rest period of 3 weeks, a challenge patch was applied for exposure period of 24 hours. Observations were done after 24 and 48 hours after removal of patch.If a challenge reaction occurred, a 2nd 24 h challenge was applied.The first insult produced faint erythema in 2 subjects while mild erythema in 1 subject. faint erythema occurred in four subjects after insult 2, in one after insult 3, and in one after insult 5. Mild erythema occurred in one person after insult 4. The challenge patch produced faint erythema in two persons after 24 h, and no reactions occurred after 48 h. No skin sensitization reactions were produced in the 116 men and women after 24 h. Hence the test material was considered as not sensitizing to the human skin.
Both the above studies were further supported by a Marzulli-Maibach repeat insult sensitization study was performed using a perfume on 235 male and female subjects to assess the skin sensitization potential of test chemical. A test was conducted using a perfume containing 1.08% of test chemical.The perfume (0.5 ml) was applied under occlusion to the skin of the upper backs of 235 men and women for 48 h (72 h on weekends). During induction,10 patches were applied for exposure period of 48 hours and every time new patches were applied to the same sites. After a rest period of 14 days, a challenge patch was applied for exposure period of 48 hours. The sites were scored on a scale of 0 (no reaction) to 5 (erythema with induration and bullae). During the induction series, one individual had erythema covering the entire test site and one had erythema with induration and vesiculation. This patient had no reaction when challenged. Seventeen subjects had slight hyperpigmentation, but no sensitization reaction occurred in any of the 235 volunteers. Hence the test material was considered as not sensitizing to the human skin.
According to Danish QSAR database, skin sensitization effects were estimated by using four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra for test chemical. Based on estimation, no Allergic Contact Dermatitis effects were observed when test chemical was exposed to human and guinea pig skin. Hence, the test chemical can be considered as not sensitizing to skin.
Based on the above summarized studies for target chemical,it can be concluded that the test chemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The skin sensitization potential of test chemical were observed in various studies. From the results obtained from these studies it is concluded that the chemical is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.
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