Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 600-687-2 | CAS number: 105839-18-7
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 September 2012 to 17 January 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Fully GLP compliant and in accordance with current test guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Test material form:
- other: viscous semi-solid
- Details on test material:
- Name: MonoFA_TETA_PAA_BADGE_BGE_Adduct
CAS number: 105839-18-7
Batch number: WA 521
Purity: 100%
Expiry date: 28 Feb 2014
Receipt date: 3 Sep 2012
Storage: Stored in sealed container at 15 to 25°C, in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaCrl
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate.
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 18 to 20 g
- Housing: Individually housed in cages that conformed to the 'Code of Practicefor the Housing and Care of Animals Used in Scientific Procedures' (Home Office, London, 1989).
- Diet (e.g. ad libitum): SQC(E) Rat and Mouse Main Diet No 1, ad libitum
- Water (e.g. ad libitum): Mains water, ad libitum
- Acclimation period: 8 to 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 20 to 24°C
- Air changes (per hr): 15 to 20 air changes per hour.
- Photoperiod (hrs dark / hrs light): The rooms were illuminated by flourescent strip-lights for twelve hours daily.
IN-LIFE DATES: From: 18 September 2012 To: 02 October 2012
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Group number 1: Vehicle control
Group 2: Low concentration (10% w/v)
Group 3: Intermediate concentration (25% w/v)
Group 4: High concentration (50% w/v) - No. of animals per dose:
- 4 animals per dose group
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: Not reported
- Irritation: No signs of irritation
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Not reported
- Criteria used to consider a positive response: Not reported
TREATMENT PREPARATION AND ADMINISTRATION: Each mouse was manually restrained with both auditory pinnae left free. The outer aspect of both pinnae of each mouse was treated by direct application of the appropriate test or control formulation (0.025 mL/pinna) dispensed from an automatic micro pipette. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- mercaptobenzothiazole (CAS No 149-30-4)
- Statistics:
- Not reported
Results and discussion
- Positive control results:
- Positive controls were not tested as a part of this test but are checked independently every 6 months,
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 15.2
- Test group / Remarks:
- 10% w/v
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Scintillation fluid with 5% w/v trichloroacetic acid: 59 DPM Vehicle control: 2152 DPM Test article, 10% w/v: 32808 DPM Test article, 25% w/v: 39115 DPM Test article, 50% w/v: 37488 DPM
- Parameter:
- SI
- Value:
- 18.2
- Test group / Remarks:
- 25% w/v
- Parameter:
- SI
- Value:
- 17.4
- Test group / Remarks:
- 50% w/v
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The Local Lymph Node Assay demonstrated that MonoFA_TETA_PPA_BADGE_BGE_Adduct has the potential to cause skin sensitisation.
The test article was classified as a Category 1 sensitiser according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). - Executive summary:
This study was conducted to assess the potential of the test article, MonoFA_TETA_PPA_BADGE_BGE_Adduct, to cause skin sensitisation in the mouse.
Following a preliminary screening test using a 50% w/v formulation, the test article was prepared for administration at 10, 25 and 50% w/v in 80% v/v acetone in olive oil. Groups of four female CBA/CaCrl mice were subjected to topical applications of vehicle or of the test formulations to the outer aspect of the auditory pinnae once daily on Days 1, 2 and 3. On Day 6 a 20 µCi dose of tritiated 3H-methyl thymidine was injected intravenously into each mouse. Approximately five hours later the auricular lymph nodes were recovered from each animal. The nodes from mice subjected to the same treatment were pooled and suspensions of the cellular components of the lymph node were prepared in 5% w/v trichloroacetic acid and processed through a scintillation counter.
Test results are expressed in terms of Stimulation Indices, the ratios of the mean scintillation count per group obtained from the test groups relative to the corresponding mean scintillation count from the controls. The threshold level for the Stimulation Index to be considered a positive indicator of the potential to cause skin sensitisation is 3.0.
Concentration of test article in applied formulation (% w/v)
10%
25%
50%
Stimulation Index
15.2
18.2
17.4
The Local Lymph Node Assay demonstrated that MonoFA_TETA_PAA_BADGE_BGE_Adduct has the potential to cause skin sensitisation.
The test article was classified as a Category 1sensitiser according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Lai gan ECHA nodrošina Jūsu valodā daudz tiešsaistes dokumentu, daļa no šīs tīmekļa lapas ir pieejama tikai angļu valodā. Lai iegūtu plašāku informāciju par ECHA daudzvalodības praksi, spiediet .
Laipni lūdzam ECHA tīmekļa vietnē! Šī vietne netiek pilnībā atbalstīta programmā Internet Explorer 7 (un agrākās versijās) “Lūdzu, nomainiet to ar jaunāku Internet Explorer versiju.”
Šajā tīmekļa vietnē tiek izmantoti sīkfaili, lai nodrošinātu Jums vislabāko lietojumu mūsu tīmekļa vietnēs.
Uzziniet vairāk par sīkfailu lietošanu.