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EC number: 690-995-3 | CAS number: 756-12-7
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 April 2012 to 14 May 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP conditions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- *Temp. dev. from the min. level of daily mean rel. humidity:Hist.data don’t indicate effect *Subst wasn’t flushed with N2:subst was weighted,kept in closed cont. & used within 2 h following weighing.Don’t expect that H2O content of air affected integrity.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- *Temp. dev. from the min. level of daily mean rel. humidity:Hist.data don’t indicate effect *Subst wasn’t flushed with N2:subst was weighted,kept in closed cont. & used within 2 h following weighing.Don’t expect that H2O content of air affected integrity.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- *Temp. dev. from the min. level of daily mean rel. humidity:Hist.data don’t indicate effect *Subst wasn’t flushed with N2:subst was weighted,kept in closed cont. & used within 2 h following weighing.Don’t expect that H2O content of air affected integrity.
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/J Strain, inbred, SPF-Quality
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Approx. 10 weeks old
- Weight at study initiation: 20-24 grams
- Housing: Labeled Makrolon cages (MIII type; height 18cm) containing sterized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France)
- Diet (e.g. ad libitum): Pelleted rodent diet (SM R/M-Z from SSNIFF Spezialdaten GmbH, Soest, Germany) ad libitum.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: At least 5 days before start of treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 25 April 2012To: 14 May 2012 - Vehicle:
- other: Water (Elix, Millipore S.A.S., Molsheim, France) with 1% pluronic L92 (BASF, New Jersey, USA)
- Concentration:
- 0, 25, 50, and 100 % (w/w) of the test subtance
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: Reacts with water, the hydrate is soluble up to 75%
- Irritation: Very slight erythema of the ears was observed at 100% test substance (w/w)
- Lymph node proliferation response:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
- Criteria used to consider a positive response: An SI value greater than or equal to 3 signifies that the test substance may be regarded as a skin sensitizer.
TREATMENT PREPARATION AND ADMINISTRATION
The dorsal suface of both ears was topically treated (25 microliters/ear) with the test substance concentration. Dosing was done using directed air extraction equipment. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Key result
- Parameter:
- SI
- Value:
- 1.4
- Test group / Remarks:
- 25% Test Article
- Key result
- Parameter:
- SI
- Value:
- 2.3
- Test group / Remarks:
- 50% Test Article
- Key result
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- 100% Test Article
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 25%: 603 50%: 1004 100%: 370
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The SI values for the 25, 50, and 100% concentrations were 1.4, 2.3, and 0.8 respectively. No EC3 value was calculated because all SI values were <3.There was very slight erythema of the ears in animals treated with the 50% and 100% concentrations of the test material, but was considered not toxicologically significant. No mortality, clinical signs of toxicity, or significant body weight change were observed. All auricular lymph nodes were considered normal in size. Based on the results of the test, extracts of the test article showed no evidence of dermal sensitization.
- Executive summary:
The dermal sensitization potential of the test article (clear colorless liquid, purity 99.99%) was evaluated in the local lymph node assay (LLNA) with CBA/J strain mice. This study was performed in compliance with OECD GLP ENV/MC/CHEM (98)17 (1997). The test method was based on OECD Section 4 No. 429 (2010), EC No. 440/2008 B42, and EPA OPPTS 870.2600 (2003). The test article was prepared in 1% watery pluronic L92 (as approved by the sponsor). A pre-screen test was conducted to select the highest test article concentrations of 100% and 50%. Female mice (5/treatment) received the control (1% L92 in water), 25%, 50%, or 100% concentrations of the test substance. The corresponding treatment (25 uL/ear) was applied to the dorsal surface of both ears for three consecutive days. Three days after the last exposure, all animals were injected with 0.25 mL of sterile phosphate buffered solution containing 3H-methyl thymidine and subsequently euthanized The auricular lymph nodes were removed to visually estimate the relative size and any abnormalities. The nodes were pooled to measure the amount of operative DNA by disintegrations per minute (DPM). The stimulation index (SI) was calculated for each group. Consideration was given to the EC3 value. The 6-month reliability check with alpha-hexylcinnamicaldehyde indicated that the LLNA is an appropriate model for evaluating dermal sensitization at the test facility. Observations for mortality (twice daily), body weights (Day 1 and 6), clinical signs (one daily), and irritation (once daily) were performed as well. Mean DPM/animal values for the 25%, 50%, and 100% test article concentrations were 603, 1004, and 370 respectively. The control mean DPM/animal value was 441. The SI values for the 25, 50, and 100% concentrations were 1.4, 2.3, and 0.8 respectively. No EC3 value was calculated because all SI values were <3. There was very slight erythema of the ears in animals treated with the 50% and 100% concentrations of the test material, but was considered not toxicologically significant. No mortality, clinical signs of toxicity, or significant body weight change were observed. All auricular lymph nodes were considered normal in size. Based on the results of the test, extracts of the test article showed no evidence of dermal sensitization.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The dermal sensitization potential of the test article (clear colorless liquid, purity 99.99%) was evaluated in the local lymph node assay (LLNA) with CBA/J strain mice. This study was performed in compliance with OECD GLP ENV/MC/CHEM (98)17 (1997). The test method was based on OECD Section 4 No. 429 (2010), EC No. 440/2008 B42, and EPA OPPTS 870.2600 (2003). The test article was prepared in 1% watery pluronic L92 (as approved by the sponsor). A pre-screen test was conducted to select the highest test article concentrations of 100% and 50%. Female mice (5/treatment) received the control (1% L92 in water), 25%, 50%, or 100% concentrations of the test substance. The corresponding treatment (25 uL/ear) was applied to the dorsal surface of both ears for three consecutive days. Three days after the last exposure, all animals were injected with 0.25 mL of sterile phosphate buffered solution containing 3H-methyl thymidine and subsequently euthanized The auricular lymph nodes were removed to visually estimate the relative size and any abnormalities. The nodes were pooled to measure the amount of operative DNA by disintegrations per minute (DPM). The stimulation index (SI) was calculated for each group. Consideration was given to the EC3 value. The 6-month reliability check with alpha-hexylcinnamicaldehyde indicated that the LLNA is an appropriate model for evaluating dermal sensitization at the test facility. Observations for mortality (twice daily), body weights (Day 1 and 6), clinical signs (one daily), and irritation (once daily) were performed as well. Mean DPM/animal values for the 25%, 50%, and 100% test article concentrations were 603, 1004, and 370 respectively. The control mean DPM/animal value was 441. The SI values for the 25, 50, and 100% concentrations were 1.4, 2.3, and 0.8 respectively. No EC3 value was calculated because all SI values were <3.There was very slight erythema of the ears in animals treated with the 50% and 100% concentrations of the test material, but was considered not toxicologically significant. No mortality, clinical signs of toxicity, or significant body weight change were observed. All auricular lymph nodes were considered normal in size. Based on the results of the test, extracts of the test article showed no evidence of dermal sensitization.
Migrated from Short description of key information:
A Local Lymph Node Assay (LLNA) for skin sensitization was conducted on CAS# 756-12-7. The result of the study was:
Non-sensitizing in the LLNA according to OECD 429.
Justification for classification or non-classification
Criteria for classifying CAS# 756-12-7 as a dermal sensitizer were not met.
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