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EC number: 281-876-3 | CAS number: 84051-87-6
- 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
By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation, other
- Remarks:
- in vivo (LLNA and non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Weight of evidence approach based on test chemicals
- Justification for type of information:
- Weight of evidence approach based on test chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: Weight of evidence approach based on test chemicals
- Principles of method if other than guideline:
- Weight of evidence approach based on test chemicals
- GLP compliance:
- not specified
- Type of study:
- other: Weight of evidence approach based on test chemicals
- Species:
- other: 1. guinea pigs; 2,3 mouse
- Strain:
- other: 1. Hartley; 2. CBA/J; 3. BALB/c
- Sex:
- female
- Route:
- intradermal
- Vehicle:
- not specified
- Concentration / amount:
- Three pairs of injections (0.05 ml each) were administered intradermally into the shaved interscapular area
: Freund’s complete adjuvant (in equal parts water), 0.1% the test chemical, and a mixture of equal parts of the adjuvant and dye - Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 25% test chemical in petrolatum
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 25% in petrolatum
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1. 10
- Details on study design:
- The data is based on weight of evidence approach based on various test chemicals
- Challenge controls:
- The data is based on weight of evidence approach based on various test chemicals
- Positive control substance(s):
- not specified
- Vehicle:
- other: 2. dimethylformamide (DMF); 3. saline and dimethylformamide (DMF)
- Concentration:
- 2. 1, 2.5, 5, 10 or 25% (w/v)
3. intradermal and topical applications were 2% and 10% respectively - No. of animals per dose:
- 2. 28
3. n=3 - Details on study design:
- The data is based on weight of evidence approach based on various test chemicals
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- A chemical was regarded as positive (a sensitizer) if it showed an SI total value of 3 or more.
- Reading:
- 1st reading
- Group:
- test chemical
- No. with + reactions:
- 0
- Clinical observations:
- no dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Parameter:
- SI
- Value:
- > 0 - <= 3
- Test group / Remarks:
- test groups
- Remarks on result:
- other: not sensitizing
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".
- Executive summary:
The skin sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.
The dermal sensitization potential of the test chemical was assessed in guinea pigs using the Kligman – Magnusson procedure.10 female Hartley guinea pigs were used for the study.
Three pairs of injections (0.05 ml each) were administered intradermally into the shaved interscapular area of each guinea pig: Freund’s complete adjuvant (in equal parts water), 0.1% the test chemical, and a mixture of equal parts of the adjuvant and dye. One week later, the sites were shaved again, and a 48-h occlusive patch containing 25% Disperse Black 9 in petrolatum was applied. Two weeks later, an occlusive challenge patch containing 25% test chemical in propylene glycol was applied to the shaved flank of each guinea pig. Sites were evaluated 24, 48, and 72 hours after patch removal.
No signs of dermal sensitization were observed on female guinea pig skin at any time point after challenge exposure.
Hence, the test chemical was considered to be not sensitizing to guinea pig skin.
This is supported by the results of LLNA assay performed on CBA/J female mice according to OECD 429 Guidelines to determine the sensitization potential of the test chemical.
The test material was soluble in dimethylformamide (DMF). This vehicle was selected on the basis of the results from a previous solubility study showing that HC Yellow n° 7 was non-soluble in other recommended vehicles, and that 25% (w/v) in DMF was the maximal practicable concentration. The test substance HC Yellow n° 7, DMF or HCA was applied in dose concentration 1, 2.5, 5, 10 or 25% (w/v) on the ears (25 μL per ear) of the animals for 3 consecutive days designated as days 1, 2 and 3. After 2 days of resting(day 6), mice received a single intravenous injection of triturated methyl thymidine (3H-TdR). Lymph nodes draining the application sites (auricular nodes) were sampled, pooled per group, and the proliferation of lymphocytes was evaluated by measuring the incorporation of 3H-TdR.The values obtained were used to calculate stimulation indices (SI), and the EC3 was estimated (theoretical concentration resulting in a SI of 3). The irritant potential of the test chemical was assessed by measuring ear thickness on days 1, 2, 3 and 6.
25% (v/v) α hexylcinnamaldehyde in DMF was used as positive control.
There were no irritation reactions and no lymphoproliferative responses, and the threshold SI of 3 values was not approached in any of the test chemical groups. Hence, the test chemical was considered to be not sensitizing in mice by LLNA method.
The above results are further supported by a sensitive mouse lymph node assay (SLNA) performed for the detection of contact allergens.
For intradermal injection of chemicals, a mixture of the chemical dissolved in saline with equivalent FCA and an emulsion was prepared for injection. Vehicle used for topical application to ears was DMF. The concentrations of the test chemical for the intradermal and topical applications were 2% and 10% respectively. Groups ofFemale BALB/c strain mice (n=3)were initially injected intradermally with a total of 50 microliters of test chemical-FCA emulsion into two sites of the abdominal skin at both sides of the ventral midline.
Five days after injection, 25 microliters of test chemical in vehicle was applied to both sides of each ear for three consecutive days. Control mice were treated by intradermal injection of vehicle-FCA emulsion into the abdomen and then after 5 days they were exposed to vehicle alone on the ears for three consecutive days. The next day following the final topical application, auricular lymph nodes were excised and pooled for each experimental group.
Control mice were treated by injection of saline-FCA emulsion and topical exposure to DMSO alone. The next day following the final topical application, auricular lymph nodes were excised and LNC suspensions were prepared. The LNCs (5 x lo5 cells/well) were cultured for 24 h and the LNC proliferation was measured by 3HTdR incorporation (cpm), or fluorescence and absorbance by the Alamar Blue assay. Increases in 3HTdR incorporation, fluorescence and absorbance relative to vehicle-treated controls were calculated for each group.
The increases in LNC number and 3HTdR incorporation relative to controls were derived for each experimental group and expressed as SIn and SIP, respectively; SItotal was obtained from SIn, x SIP, which indicates the total lymph node activation induced by the test chemicals. A chemical was regarded as positive (a sensitizer) if it showed an SI total value of 3 or more.
The SItotal value for the test chemical was 0.80.EC3 could not be calculated as the SI total was less than 3. Hence the test chemical was considered to be not sensitizing to the skin of BAlb/c mice in the SLNA assay.
By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.
The dermal sensitization potential of the test chemical was assessed in guinea pigs using the Kligman – Magnusson procedure.10 female Hartley guinea pigs were used for the study.
Three pairs of injections (0.05 ml each) were administered intradermally into the shaved interscapular area of each guinea pig: Freund’s complete adjuvant (in equal parts water), 0.1% the test chemical, and a mixture of equal parts of the adjuvant and dye. One week later, the sites were shaved again, and a 48-h occlusive patch containing 25% Disperse Black 9 in petrolatum was applied. Two weeks later, an occlusive challenge patch containing 25% test chemical in propylene glycol was applied to the shaved flank of each guinea pig. Sites were evaluated 24, 48, and 72 hours after patch removal.
No signs of dermal sensitization were observed on female guinea pig skin at any time point after challenge exposure.
Hence, the test chemical was considered to be not sensitizing to guinea pig skin.
This is supported by the results of LLNA assay performed on CBA/J female mice according to OECD 429 Guidelines to determine the sensitization potential of the test chemical.
The test material was soluble in dimethylformamide (DMF). This vehicle was selected on the basis of the results from a previous solubility study showing that HC Yellow n° 7 was non-soluble in other recommended vehicles, and that 25% (w/v) in DMF was the maximal practicable concentration. The test substance HC Yellow n° 7, DMF or HCA was applied in dose concentration 1, 2.5, 5, 10 or 25% (w/v) on the ears (25 μL per ear) of the animals for 3 consecutive days designated as days 1, 2 and 3. After 2 days of resting(day 6), mice received a single intravenous injection of triturated methyl thymidine (3H-TdR). Lymph nodes draining the application sites (auricular nodes) were sampled, pooled per group, and the proliferation of lymphocytes was evaluated by measuring the incorporation of 3H-TdR.The values obtained were used to calculate stimulation indices (SI), and the EC3 was estimated (theoretical concentration resulting in a SI of 3). The irritant potential of the test chemical was assessed by measuring ear thickness on days 1, 2, 3 and 6.
25% (v/v) α hexylcinnamaldehyde in DMF was used as positive control.
There were no irritation reactions and no lymphoproliferative responses, and the threshold SI of 3 values was not approached in any of the test chemical groups. Hence, the test chemical was considered to be not sensitizing in mice by LLNA method.
The above results are further supported by a sensitive mouse lymph node assay (SLNA) performed for the detection of contact allergens.
For intradermal injection of chemicals, a mixture of the chemical dissolved in saline with equivalent FCA and an emulsion was prepared for injection. Vehicle used for topical application to ears was DMF. The concentrations of the test chemical for the intradermal and topical applications were 2% and 10% respectively. Groups ofFemale BALB/c strain mice (n=3)were initially injected intradermally with a total of 50 microliters of test chemical-FCA emulsion into two sites of the abdominal skin at both sides of the ventral midline.
Five days after injection, 25 microliters of test chemical in vehicle was applied to both sides of each ear for three consecutive days. Control mice were treated by intradermal injection of vehicle-FCA emulsion into the abdomen and then after 5 days they were exposed to vehicle alone on the ears for three consecutive days. The next day following the final topical application, auricular lymph nodes were excised and pooled for each experimental group.
Control mice were treated by injection of saline-FCA emulsion and topical exposure to DMSO alone. The next day following the final topical application, auricular lymph nodes were excised and LNC suspensions were prepared. The LNCs (5 x lo5 cells/well) were cultured for 24 h and the LNC proliferation was measured by 3HTdR incorporation (cpm), or fluorescence and absorbance by the Alamar Blue assay. Increases in 3HTdR incorporation, fluorescence and absorbance relative to vehicle-treated controls were calculated for each group.
The increases in LNC number and 3HTdR incorporation relative to controls were derived for each experimental group and expressed as SIn and SIP, respectively; SItotal was obtained from SIn, x SIP, which indicates the total lymph node activation induced by the test chemicals. A chemical was regarded as positive (a sensitizer) if it showed an SI total value of 3 or more.
The SItotal value for the test chemical was 0.80.EC3 could not be calculated as the SI total was less than 3. Hence the test chemical was considered to be not sensitizing to the skin of BAlb/c mice in the SLNA assay.
By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The results of the experimental studies from the various test chemicals indicate a possibility that the test chemical can be not sensitizing to skin.
Hence, by applying the weight of evidence approach,the test chemical can be considered to be not sensitizing to skin.
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