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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experiment start date - 03 November 2009; Experiment completion date - 01 December 2009; Study completion date - 01 March 2010.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Details on test material:
- - Substance type: reactive dyestuff
- Physical state: orange powder
- Analytical purity: 69.9% of all colored components
- Lot/batch No.: TZ 5891 / BOP 02-09
- Expiration date of the lot/batch: 2014-07-31
- Storage condition of test material: At room temperature at about 20 °C
Constituent 1
- Specific details on test material used for the study:
- Identification: FAT 40851/A TE
Batch Number: TZ 5891 / BOP 02-09
Purity: 69.9 % all coloured components
Appearance: Orange powder
Expiry Date: July 31, 2014
Storage Conditions: At room temperature at about 20 °C
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS: Mice, CBA/CaOlaHsd
- Source: Harlan Laboratories B.V. Postbus 6174, 5960 AD Horst / The Netherlands
- Age at study initiation: 8 - 12 weeks (beginning of treatment)
- Weight at study initiation: 18.8 - 24.0 g
- Housing: Single caging
- Diet : pelleted standard diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6-7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): relative humidity 45-65 %
- Photoperiod (hrs dark / hrs light): 12/12
- bedding: granulated soft wood bedding
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Concentration:
- The highest test item concentration, which can be technically used was a 25 % suspension in methylethylketone.
First pre-test two mice were treated with concentrations of 10 and 25 %. Second pre-test two mice were treated with concentrations of 2.5 and 5 %. The test item in the main study was assayed at 1, 2.5, and 5 %. - No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: The highest test item concentration, which can be technically used was a 25 % suspension in methylethylketone. In the first pre-test two mice were treated with concentrations of 10 and 25 % each on three consecutive days. Within 1 hour after the first and second and 24 hours after the third application both animals showed reduced spontaneous activity and eyelid closure. In the second pre-test two mice were treated with concentrations of 2.5 and 5 % each on three consecutive days. At the tested concentrations the animals did not show any signs of irritation or systemic toxicity.
MAIN STUDY
TOPICAL APPLICATION
Each of the three groups of four female mice was treated by topical (epidermal) application to the dorsal surface of each ear lobe (left and right) with different test item concentrations of 1, 2.5, and 5% (w/v) in methylethylketone. The application volume, 25 μl, was spread over the entire dorsal surface (Ø ~ 8 mm) of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals).
ADMINISTRATION OF 3H-METHYL THYMIDINE AND DETERMINATION OF INCORPORATED 3H-METHYL THYMIDINE
Five days after the first topical application, the mice were intravenously injected into a tail vein with radio-labelled thymidine (³H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed and the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of ³H-methyl thymidine measured in a beta-scintillation counter.
INTERPRETATION OF RAW DATA
The proliferative response of lymph node cells is expressed as the number of radioactive disintegrations per minute per lymph node (DPM/node) and as the ratio of ³HTdR incorporated into lymph node cells of test lymph nodes relative to that recorded for control lymph nodes (stimulation index). Before DPM/node values were determined, mean scintillation-background DPM was subtracted from test and control raw data. A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of the test item resulted in an incorporation of ³HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the stimulation index.
- Second, that the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
OBSERVATIONS
In addition to the sensitising reactions the following observations and data were recorded during the test and observation period:
Mortality / Viability: once daily (week day) from experimental start to necropsy.
Body weights: prior to the first application and prior to treatment with 3HTdR.
Clinical signs (local / systemic): In the pre-test clinical signs were recorded within 1 hour and 24 ± 4 hours after each application as well as on day 7. In the main experiment clinical signs were recorded within 1 hour after each application, and 24 ± 4 hours after the first and second application as well as on the day of preparation. Especially the treatment sites were observed carefully. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Before DPM/node values were determined, mean scintillation-background DPM was subtracted from test and control raw data. The mean values and standard deviations were calculated in the body weight tables.
Results and discussion
- Positive control results:
- In the study with the positive control substance alpha-hexyl cinnamic aldehyde, Stimulation Indices of 1.79, 2.09, and 6.84 were determined with test item concentrations of 5, 10, and 25 % in acetone:olive oil (4+1). The EC3 value was calculated to be 12.9 %. The test item positive control substance alpha-hexyl cinnamic aldehyde was found to be a skin sensitiser under the described conditions, demonstrating the validity of the study.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- EC3
- Value:
- 1.1
- Parameter:
- SI
- Value:
- 2.83
- Test group / Remarks:
- 1 % Test item concentration
- Parameter:
- SI
- Value:
- 5.43
- Test group / Remarks:
- 2.5 % Test item concentration
- Parameter:
- SI
- Value:
- 7.16
- Test group / Remarks:
- 5 % Test item concentration
Any other information on results incl. tables
Calculation and Results of Individual Data; Vehicle: methylethylketone
Test item concentration | Group | Measured DPM | Calculation | Result | ||
DPM – BGa) | number of lymph nodes | DPM per lymph nodeb) | S.I. | |||
- | BG 1 | 25 | - | - | - | - |
- | BG 2 | * | - | - | - | - |
- | 1 | 1838 | 1813 | 8 | 226.6 | 1.00 |
1 | 2 | 5164 | 5139 | 8 | 642.4 | 2.83 |
2.5 | 3 | 9865 | 9840 | 8 | 1230.0 | 5.43 |
5 | 4 | 13009 | 12984 | 8 | 1623.0 | 7.16 |
BG = Background (1 ml 5% trichloroacetic acid) in duplicate
1 = Control Group
2-4 = Test Group
S.I. = Stimulation Index
a)= The mean value was taken from the figures BG I and BG II
b)= Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled
* = value could not be used, due to a technical problem
VIABILITY / MORTALITY: No deaths occurred during the study period.
CLINICAL SIGNS: No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.
BODY WEIGHTS: The body weight of the animals, recorded prior to the first application and prior to treatment with ³HTdR, was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- The test item was found to be a skin sensitiser under the described conditions.
- Executive summary:
In order to study a possible contact allergenic potential of FAT 40851/A, a local lymph node assay according to OECD guideline 429 was performed under GLP. Three groups each of four female mice were treated daily with the test item at concentrations of 1, 2.5, and 5 % (w/w) in methyl ethyl ketone by topical application to the dorsum of each ear lobe (left and right) for three consecutive days. A control group of four mice was treated with the vehicle (methyl ethyl ketone) only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (³H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of ³H-methyl thymidine measured in a scintillation counter. All treated animals survived the scheduled study period and no signs of toxicity were observed. A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentration resulted in 3-fold or greater increase in incorporation of ³HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value. In this study Stimulation Indices of 2.83, 5.43, and 7.16 were determined with the test item at concentrations of 1, 2.5, and 5 % in methyl ethyl ketone. The EC3 value calculated was 1.1 %. The test item FAT 40851/A was found to be a skin sensitiser under the described conditions.
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)
Embora a ECHA disponibilize muito material em linha na sua língua, uma parte desta página está disponível apenas em inglês. Mais informações sobreas práticas de multilinguismo da ECHA.
Bem-vindo ao sítio Web da ECHA O navegador Internet Explorer 7 (e versões anteriores) não é totalmente suportado por este sítio Web. Por favor atualize o seu Internet Explorer para uma versão mais recente.
Este sítio Web utiliza cookies a fim de garantir a melhor experiência possível nos nossos sítios Web.
Saiba mais sobre como utilizar cookies.