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Diss Factsheets
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EC number: 482-430-2 | 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
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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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed to GLP
- 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
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/CaBkl
- Sex:
- female
- Details on test animals and environmental conditions:
- Source: B & K Universal Ltd
Environmental conditions:
Housed individually in suspended solid floor cages.
Temperature: 19-25ºC
Humidity: 30-70%
Acclimitisation period: 5 days
Air changes: 15 per hour
Lighting: 12 hours continuous light and twelve hours darkness
Free access to mains drinking water and food - Vehicle:
- dimethylformamide
- Concentration:
- 10, 25 or 50 %
- No. of animals per dose:
- Preliminary test: two mice
Main test: Groups of four mice - Details on study design:
- Preliminary Screening test.
A preliminary screening test was performed using two mice. The mice were treated by daily application of 25µl of the undiluted test material and the test material at a concentration of 50% v/v in dimethyl formamide, to the dorsal surface of each ear for three consecutive days (Days 1, 2 and 3). The mice were observed twice daily on Day 1 and the surviving mouse on Days 2 and 3 and once daily on Days 4, 5 and 6. Any signs of toxicity or excessive local irritation noted during this time period were recorded. The body weight of each mouse was recorded on Day 1 (prior to dosing) and the surviving mouse on Day 6.
Main test
Groups of 4 mice were treated with the test material at concentrations of 10%, 25% or 50% v/v in dimethyl formamide. The preliminary screening test suggested that the test material would not produce systemic toxicity or excessive local irritation at the highest suitable concentration. The mice were treated by daily application of 25µl of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 1, 2 and 3). The test material formulation was administered using an automatic micropipette and spread over the surface of the ear using the tip of the pipette.
A further group of four mice received the vehicle alone in the same manner.
Five days following the first topical application of the test material (Day 6) all mice were injected via the tail vein with 250µl of phosphate buffered saline (PBS) containing 3H-methyl thymidine giving a total of 20 µCi to each mouse.
The mice were observed twice daily on Day 1 and the surviving mouse on Days 2 and 3 and once daily on Days 4, 5 and 6. - Parameter:
- SI
- Value:
- 3.13
- Test group / Remarks:
- 10 % concentration
- Parameter:
- SI
- Value:
- 3.37
- Test group / Remarks:
- 25 % concentration
- Parameter:
- SI
- Value:
- 7.45
- Test group / Remarks:
- 50 % concentration
- Interpretation of results:
- other: Sensitising
- Conclusions:
- The test material was considered to be a sensitiser under the conditions of the test.
- Executive summary:
A GLP study was performed in accordance with OECD 429 to assess the skin sensitisation potential of Inhibitor AHM P500 in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear.
Following a preliminary screening test, three groups, each of four animals, were treated with 50µl (25 µl per ear) of the test material as a solution in dimethyl formamide at concentrations of 10%, 25% or 50% v/v daily for a period of 3 days. A further group of four animals was treated with dimethyl formamide alone.
Five days following the first topical application all mice were injected with a solution of 3H-methyl thymidine (3HTdR). Five hours after administration of3HTdR, all mice were necropsied and the auricular lymph nodes from each group pooled for analysis.
The Stimulation Index (SI), expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group, was determined. Positive results for sensitisation by skin contact were obtained at all test concentrations, therefore the test material is considered to be a sensitiser under the conditions of the test.
Reference
Concentration (%v/v) in dimethyl formamide |
Dpm |
Dpm/Node a |
Stimulation index (SI)b |
Result |
Vehicle |
4485.95 |
560.74 |
N/A |
N/A |
10 |
14062.86 |
1757.86 |
3.13 |
Positive |
25 |
15126.04 |
1890.76 |
3.37 |
Positive |
50 |
33415.68 |
4176.96 |
7.45 |
Positive |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
- Justification for selection of skin sensitisation endpoint:
Single GLP guideline study available
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based upon the above information the substance meets the criteria for classification as set out by both 67/548/EEC and EC Regulation 1272/2008 and should therefore be classified as follows:
R43 - May cause sensitisation by skin contact.
Skin Sens 1 - H317 May cause an allergic skin reaction.
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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