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Diss Factsheets
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EC number: 943-492-0 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 October 2006 - 13 December 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L 'Arbresle Cedex, France
- Age at study initiation: ca. 11 weeks
- Housing: animals were housed individually in labelled Macrolon cages furnished with sterilised sawdust as bedding material.
- Diet: pelleted rodent diet (SM R/M-Z from SNIFF® Spezialdiäten GmbH, Soets, Germany) ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1 - 22.7 °C
- Humidity (%): 43 - 89 %
- Air changes (per hr): ca. 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 10, 25 and 50%
- No. of animals per dose:
- 5
- Details on study design:
- In the main study, three groups of five experimental animals were treated with 25 µL test material concentrations of 10%, 25% or 50% on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with vehicle alone (dimethyl formamide). Three days after the last exposure, all animals were injected with 0.25 mL 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised. After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of Disintegrations Per Minute (DPM) and a stimulation index was subsequently calculated for each group.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The SI values calculated for the substance concentrations 5, 10 and 25% were 1.4, 2.2 and 6.2 respectively. An EC3 value of 13.1% was calculated using linear interpolation.
The calculated EC3 value was found to be in the acceptable range of 2 and 20%. The results of the 6 monthly HCA reliability checks of the recent years were 8.8, 5.5, 7.3 and 10.3%.
Based on the results, it was concluded that the Local Lymph Node Assay as performed at NOTOX is an appropriate model for testing for contact hypersensitivity.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks:
- 10%
- Value:
- 1.4
- Parameter:
- SI
- Remarks:
- 25%
- Value:
- 2.2
- Parameter:
- SI
- Remarks:
- 50%
- Value:
- 6.2
- Parameter:
- EC3
- Value:
- 13.1
- Test group / Remarks:
- Extrapolated
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Mean DPM/animal values for the experimental groups treated with test substance concentrations 10, 25 and 50% were 408, 727 and 582 respectively. The mean DPM/animal value for the vehicle control group was 290.
Any other information on results incl. tables
Skin reaction/ irritation
No skin reactions were observed in any of the animals examined.
Macroscopy of the auricular lymph nodes and surrounding area
All nodes of the experimental and control groups were
considered normal in size.
No macroscopic abnormalities of the surrounding area were noted.
Body weights
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
Toxicity and mortality
No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.
Positive control
The six monthly reliability check with Hexylcinnamic aldehyde indicates that the Local Lymph Node Assay as performed at NOTOX is an appropriate model for testing for contact hypersensitivity.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study the test material was found not to be a skin sensitiser.
- Executive summary:
The potential of the test material to cause skin sensitisation was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 429, EU Method B.42 and EPA OPPTS 870.2600.
Test material concentrations selected for the main study were based on the results of a preliminary study.
In the main study, three groups of five experimental animals were treated with test material concentrations of 10%, 25% or 50% on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with vehicle alone (dimethyl formamide). Three days after the last exposure, all animals were injected with 0.25 mL 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised. After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of Disintegrations Per Minute (DPM) and a stimulation index was subsequently calculated for each group.
No skin reactions were observed in any of the animals examined.
All nodes of the experimental and control groups were considered normal in size. No macroscopic abnormalities of the surrounding area were noted.
Mean DPM/animal values for the experimental groups treated with test substance concentrations 10, 25 and 50% were 408, 727 and 582 respectively.
The mean DPM/animal value for the vehicle control group was 290.
The SI values calculated for the substance concentrations 10%, 25% and 50% were 1.4, 2.5 and 2.0 respectively.
Since there was no indication that the test material could elicit an SI ≥ 3 when tested up to 50%, it was established that the EC3 value (if any) exceeds 50%.
The six monthly reliability check with Hexylcinnamic aldehyde indicates that the Local Lymph Node Assay as performed at the test laboratory is an appropriate model for testing for contact hypersensitivity.
Based on these results, the test material was not considered to be a skin sensitiser.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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