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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 284-698-4 | CAS number: 84962-05-0
- 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:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Test material form:
- other: waxy solid
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- Sponsor's identification: FAT 93580/A
Description: extremely pale yellow waxy solid
Batch number: 0022357000
Purity:94.3%
Date received: 23 January 2013
Expiry Date: 15 December 2015
Storage conditions: room temperature in the dark
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK.
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: 15 - 23 g
- Housing: individually in suspended solid-floor polypropylene cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark/hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 2.5, 5 or 10 % w/w in propylene glycol
- No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: 25 µI of the test item at a concentration of 10% w/w in propylene glycol
- Irritation: None
- Ear thickness measurements: Post dosing day 1, day 3 and day 6.
- Erythema scores: Daily
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Estimation of the Proliferative Response of Lymph Node Cells
- Criteria used to consider a positive response: The test item will be regarded as a sensitizer if at least one concentration of the test item results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test item failing to produce a threefold or greater increase in ³HTdR incorporation will be classified as a "non-sensitizer".
TREATMENT PREPARATION AND ADMINISTRATION: Groups of four mice were treated with the test item at concentrations of 10, 5 or 2.5 % w/w in propylene glycol. The preliminary screening test suggested that the test item would not produce systemic toxicity or excessive local skin irritation at the highest suitable concentration. The mice were treated by daily application of 25 μL of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test item formulation was administered using an automatic micropipette and spread over the dorsal 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 item or vehicle (Day 6) all mice were injected via the tail vein with 250 μL of phosphate buffered saline (PBS) containing 3H-methyl thymidine (³HTdR: 80 μCi/mL, specific activity 2.0 Ci/mmol, ARC UK Ltd) giving a total of 20 μCi to each mouse. - Positive control substance(s):
- other: Phenylacetaldehyde (>90 %)
- Statistics:
- None
Results and discussion
- Positive control results:
- Test Item: Phenylacetaldehyde (>90 %)
Stimulation Index: 6.32
Result: Positive
Conclusion. Phenylacetaldehyde (>90 %) was considered to be a sensitizer under the conditions of the test.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.37
- Test group / Remarks:
- 2.5%
- Parameter:
- SI
- Value:
- 1.27
- Test group / Remarks:
- 5 %
- Parameter:
- SI
- Value:
- 1.71
- Test group / Remarks:
- 10 %
- Cellular proliferation data / Observations:
- CLINICAL OBSERVATION:
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.
Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period.
No irritation was observed at the maximal concentration tested (10 %).
Any other information on results incl. tables
Table 1. Disintegrations per Minute, Disintegrations per Minute/Node and Stimulation Index
Concentration (% w/w) in propylene glycol |
dpm |
Dpm/Nodea |
Stimulation Indexb |
Result |
Vehicle |
4607.43 |
575.93 |
na |
na |
2.5 |
6301.03 |
787.63 |
1.37 |
negative |
5 |
5861.93 |
732.74 |
1.27 |
negative |
10 |
7891.20 |
986.40 |
1.71 |
negative |
a: disintegrations per minute/node obtained by dividing the disintegrations per minute value by 8 (total number of lymph nodes)
b: stimulation index of 3.0 or greater indicates a positive result
na = not applicable
Positive control : Phenylacetaldehyde (90 %)
Concentration (% v/v) in propylene glycol |
Stimulation Index |
Result |
2.5 |
6.32 |
Positive |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD TG 429 and EU Method B.42, the test item FAT #: 93580/A was considered to be a non-sensitizer.
- Executive summary:
A study was performed to assess the skin sensitisation potential of the test item FAT 93580/A in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear according to OECD TG 429 and Method B42 (EC) and as per GLP.
Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 10 % w/w, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 μl (25 μl per ear) of the test item as a suspension in propylene glycol at concentrations of 2.5, 5 or 10 % w/w. A further group of four animals was treated with propylene glycol alone.
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 are as follows:
Concentration (% w/w) in propylene glycol
Stimulation Index
Result
2.5
1.37
negative
5
1.27
negative
10
1.71
negative
Based on the findings, the test item FAT #: 93580/A was considered to be a non-sensitizer.
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)
Kuigi ECHA veebilehe paljud osad on sinu keeles olemas, on see leht osaliselt inglise keeles. Lisateave ECHA mitmekeelsuse kohta.
Tere tulemast Euroopa Kemikaaliameti (ECHA) veebilehele! Internet Explorer 7 (ja varasemad versioonid) ei toeta täielikult seda veebilehte. Uuendage oma Internet Exploreri versiooni.
Sellel veebilehel kasutatakse küpsiseid, et tagada lehe parim kasutus.
Lisateave küpsiste kohta.