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EC number: 947-582-0 | CAS number: -
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 October 2015 to 29 October 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- United States Code of Federal Regulations, Title 40, Parts 792
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- According to OECD 429 guideline, „despite the advantages of the LLNA over TG 406, it should be recognised that there are certain limitations that may necessitate the use of TG 406 (13) (e.g. false negative findings in the LLNA with certain metals, false positive findings with certain skin irritants [such as some surfactant type chemicals]…” Basketer & Kimber (2011) and Ball et al. (2011) conducted a battery of in vivo and in vitro tests with several exemplary surfactant and confirmed that the LLNA tends to overestimate the sensitization potential of surfactants. Even though the registered substance barium sulfonate has no surfactant properties, the read across substances are in several cases, and the Buehler tests (OECD TG 406) conducted with the calcium sulfonate read-across substances are more appropriate to differentiate between the skin sensitization potential of low and high TBN calcium sulfonates. Calcium sulfonates with a large excess of calcium carbonate are referred to as high overbased or high total base number (TBN) calcium sulfonates, whereas calcium sulfonates with small amounts of added calcium carbonate are called low overbased or low TBN calcium sulfonates. The results of numerous animal studies and human repeat insult patch tests clearly showed that low TBN calcium sulfonates (TBN < 300) are skin sensitisers with a specific concentration limit (SCL) of 10% and that high TBN calcium sulfonates (TBN ≥ 300) are not skin sensitisers. Thus, to confirm this assumption Buehler test was chosen.
Test material
- Reference substance name:
- Benzene, mono-C10-13-alkyl derivs., distn. residues, sulfonated, barium salts
- EC Number:
- 947-582-0
- Molecular formula:
- Too complex
- IUPAC Name:
- Benzene, mono-C10-13-alkyl derivs., distn. residues, sulfonated, barium salts
- Test material form:
- liquid: viscous
1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Kept in a controlled temperature area
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: Male range finding animals - 5 weeks. Female range finding animals - 6 weeks. Male main phase animals - 6 weeks. Female main phase animals - 7 weeks. Male second range finding animals - 9 weeks. Female second range finding - 10 weeks.
- Weight at study initiation: Male range finding animals - 348-380 g. Female range finding animals - 326-330 g. Male main phase animals - 365-474 g. Female main phase animals - 349-433 g. Male second range finding animals - 564-597 g. Female second range finding - 463-477 g.
- Housing: Pair housing (same sex and dosing group. Polycarbonate cages containing direct bedding material.
- Diet: ad libitum (except during procedures)
- Water: Municipal tap water treated by reverse osmosis and UV irradiation available ad libitum
- Acclimation period: At least 7 days
- Indication of any skin lesions: Only healthy animals were used during the test
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22 °C
- Humidity (%): 45 - 54 %
- Air changes (per hr): Ten or more changes per hour with 100 % fresh air (no recirculation)
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
- IN-LIFE DATES: From: To: 25-27 November 2015
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 % (0.3 mL)
- Day(s)/duration:
- 6 hours on days 1, 7 and 14
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- 25 % (0.3 mL)
- Day(s)/duration:
- 6 hours on Day 28
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Test group:
10 animals per sex per dose
Challenge control:
5 animals per sex per dose
HCA Test:
5 animals per sex per dose (2.5 % and 1 % HCA in ethanol)
HCA Control:
5 animals per sex per dose (2.5 % and 1 % HCA in ethanol) - Details on study design:
- RANGE FINDING TESTS:
1st Range finder:
2 animals per sex per dose (concentrations 100, 75, 50 and 25 %)
2nd Range finder:
2 animals per sex per dose (concentrations 75 and 50 %)
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: Days 1, 7 and 14
- Test groups: Test group
- Control group: Positive control group
- Site: 1
- Frequency of applications: 1 application
- Duration: 6 hours
- Concentrations: 100 % test group, 5 % in ethanol HCA control group
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 28
- Exposure period: 6 hours
- Test groups: Test and Challenge groups
- Control group: HCA test and Control group
- Site: Test and Challenge control group - site 2. HCA test and Control - Site 2 at 2.5 % and Site 4 at 1 %
- Concentrations: Test and Challenge control - 25 % in mineral oil. HCA test and Control - 1 and 2.5 %
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- Yes, challenge control performed with 25 % test material in mineral oil on day 28.
- Positive control substance(s):
- yes
- Remarks:
- α-Hexylcinnamaldehyde (HCA) (in ethanol)
Results and discussion
- Positive control results:
- Following challenge with 2.5% w/v HCA in acetone, dermal scores of 1 or 2 were noted in 10/10 HCA test animals at the 24-hour and 48-hour scoring intervals. Dermal reactions in the HCA control animals were limited to scores of 0. Group mean dermal scores were higher in the HCA test animals (1.8 to 1.9) compared to the HCA control animals (0.0). Following challenge with 1.0% w/v HCA in acetone, dermal scores of 1 or 2 were noted in 9/10 HCA test animals at the 24-hour scoring interval and in 8/10 HCA test animals at the 48-hour scoring interval. Dermal reactions in the remaining HCA test animal and HCA control animals were limited to scores of 0 or ±. Group mean dermal scores were higher in the HCA test animals (1.0 to 1.1) compared to the HCA control animals (0.0).
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Clinical observations:
- Group mean dermal scores 1.2 to 1.3. No effects on bodyweight were observed.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
- Group mean dermal scores 1.2 to 1.3. No effects on bodyweight were observed.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 % (challenge control)
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Group mean dermal scores 0.2
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 % (challenge control)
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Group mean dermal scores 0.2
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 2.5 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1 %
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 2.5 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1 %
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Range finding phase:
Based on the initial range-finding phase, the 100% as received concentration was considered appropriate for conducting the induction phase as no dermal irritation was present at concentrations of 100%, 75%, 50%, or 25%. During induction, irritation was observed at the 100% concentration, therefore, prior to challenge, a second range-finding phase was conducted by repeating the 75% and 50% concentration. The second range-finding showed a progressive decrease in response with concentration. Therefore, the weight-of-evidence indicated that it was appropriate to consider a 25% concentration as the highest non-irritating concentration.
Induction phase:
During the induction phase, dermal scores of ± (slight patchy erythema), 1 (slight, but confluent or moderate patchy erythema), and 2 (moderate, confluent erythema) were noted for the test animals.
Table 2: Dermal Scores - Results of challenge readings
Group |
Sex |
Animal |
Dermal Scores (25 %) |
|
24 |
48 Hours |
|||
Test |
Male |
6005 |
1 |
1 |
6006 |
2 |
2 |
||
6007 |
1 |
1 |
||
6008 |
1 |
1 |
||
6009 |
2 (ED-1) |
2 |
||
6010 |
2 |
2 |
||
6011 |
1 |
1 |
||
6012 |
2 |
2 |
||
6013 |
1 |
1 |
||
6014 |
1 |
1 |
||
Female |
6049 |
1 |
2 |
|
6050 |
2 |
2 |
||
6051 |
1 |
1 |
||
6052 |
2 |
1 |
||
6053 |
0 |
0 |
||
6054 |
1 |
1 |
||
6055 |
1 |
1 |
||
6056 |
± |
1 |
||
6057 |
2 |
2 |
||
6058 |
0 |
1 |
||
Mean Test |
1.2 |
1.3 |
||
Challenge control |
Male |
6015 |
0 |
0 |
6016 |
0 |
0 |
||
6017 |
± |
± |
||
6018 |
0 |
0 |
||
6019 |
0 |
0 |
||
Female |
6059 |
± |
± |
|
6060 |
1 |
1 |
||
6061 |
0 |
0 |
||
6062 |
0 |
0 |
||
6063 |
0 |
0 |
||
Mean Challenge control |
0.2 |
0.2 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Based on the results of this study, the test material is considered to be a contact sensitizer in guinea pigs. The criterion for sensitization (dermal scores ≥ 1 in at least 15% of the test animals) was met at challenge, even with a single naïve animal responding with a dermal score of 1, as 35% of the test animals responded with a dermal score of 2. There was a clear demonstration of sensitization potential in the guinea pig based on increasing irritation during induction with a similar to higher dermal response at challenge, as would be expected in the guinea pig when sensitized to a test substance. The results of the HCA positive control study demonstrated that a valid test was performed and indicated that the test design would detect potential contact sensitizers.
- Executive summary:
SUMMARY
The dermal sensitization potential of the test material was evaluated in Hartley-derived albino guinea pigs. In the induction phase, 10 male and 10 female guinea pigs were topically treated with the test material, as received, once per week, for 3 consecutive weeks.
Following a 2-week rest period, a challenge was performed whereby the 20 test and 10 previously untreated (naïve) challenge control guinea pigs were topically treated with 25% of the test material in mineral oil.
Anα-Hexylcinnamaldehyde (HCA) positive control group consisting of 10 HCA test and 10 HCA control guinea pigs was included in this study. The animals were treated as above with
the HCA test animals receiving 5% w/v HCA in ethanol for induction and 2.5% and 1.0% w/v HCA in acetone for challenge.
Test Material
Following challenge with 25% test material in mineral oil, dermal scores of 1 or 2 were noted in 17/20 test animals and 1/10 challenge control animals at the 24-hour scoring interval. At the 48-hour scoring interval, dermal scores of 1 or 2 were noted in 19/20 test animals and 1/10 challenge control animals. Dermal reactions in the remaining test and challenge control animals were scores of 0 or ±. Group mean dermal scores were higher in the test animals (1.2 to 1.3) as compared to challenge control animals (0.2 to 0.2).
α-Hexylcinnamaldehyde (HCA) (Positive control)
Following challenge with 2.5% w/v HCA in acetone, dermal scores of 1 or 2 were noted in 10/10 HCA test animals at the 24-hour and 48-hour scoring intervals. Dermal reactions in the HCA control animals were limited to scores of 0. Group mean dermal scores were higher in the HCA test animals (1.8 to 1.9) compared to the HCA control animals (0.0).
Following challenge with 1.0% w/v HCA in acetone, dermal scores of 1 or 2 were noted in 9/10 HCA test animals at the 24-hour scoring interval and in 8/10 HCA test animals at the 48-hour scoring interval. Dermal reactions in the remaining HCA test animal and HCA control animals were limited to scores of 0 or ±. Group mean dermal scores were higher in the HCA test animals (1.0 to 1.1) compared to the HCA control animals (0.0).
Conclusion
Based on the results of this study, the test material is considered to be a contact sensitizer in guinea pigs. The criterion for sensitization (dermal scores≥1 in at least 15% of the test animals) was met at challenge, even with a single naïve animal responding with a dermal score of 1, as 35% of the test animals responded with a dermal score of 2. There was a clear demonstration of sensitization potential in the guinea pig based on increasing irritation during induction with a similar to higher dermal response at challenge, as would be expected in the guinea pig when sensitized to a test substance. The results of the HCA positive control study demonstrated that a valid test was performed and indicated that the test design would detect potential contact sensitizers.
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