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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 947-646-8 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20th Aug 2015 - 8th October 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 22 July 2010
- Deviations:
- no
- Qualifier:
- equivalent or similar 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
- Reference substance name:
- Reaction Mass of Mixed Xylenes and Sulphur Monochloride
- IUPAC Name:
- Reaction Mass of Mixed Xylenes and Sulphur Monochloride
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation:15 to 23g
- Housing: Suspended solid floor polypropylene cages furnished with softwood flakes.
- Diet (e.g. ad libitum): ad libitium
- Water (e.g. ad libitum): ad libitium
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 70%
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 1,2.5 and 5% v/v
- No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS
- Irritation: No local skin irritation was observed with undiluted test item or 50, 25, 10 or 5% v/v dilutions.
- Systemic toxicity: The animal dosed with 100% undiluted test item was killed on day 4 due to effects of systemic toxicity. No effects were observed in the surviving animals.
- Ear thickness measurements: Increases in ear thickness were observed in all dose groups by day 6.
50% dose groups : 52.5% increase in ear thickness
25% dose group: 63.6% increase in ear thickness
10% dose group: 27.9% increase in ear thickness
5% dose group: 2.38% increase in ear thickness
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: The test item will be regarded as as a sensitizer if at least one concentration of the test item results in a thhree fold or greater increase in 3HTdR incorporation compared to control values.
TREATMENT PREPARATION AND ADMINISTRATION:
The mice were treated with a daily application of 25 microlitres of the dose solution to the dorsal surface of each ear for three consecutive days using an automatic micropipette and spread of the surface using the tip. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- A group of 5 animals was treated wih 50 microlitres (25 per ear) of a 25% v/v solution of alpha-hexylcinnamaldehyde tech (85% purity) in acetone/olive oil 4:1.
A futher control group of 5 animals was dosed with the vehicle.
A stimulation index value of 13.93 was obtained indicating a positive response.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- ca. 3.11
- Variability:
- Not applicable - pooled method
- Test group / Remarks:
- 5% v/v
- Remarks on result:
- other: Positive indication of skin sensitization based on study results.
- Parameter:
- SI
- Value:
- ca. 0.72
- Variability:
- Not applicable - pooled method
- Test group / Remarks:
- 2.5% v/v
- Remarks on result:
- other: Negative indication of skin sensitization based on study results
- Parameter:
- SI
- Value:
- ca. 0.94
- Variability:
- Not applicable - pooled method
- Test group / Remarks:
- 1% v/v
- Remarks on result:
- other: Negative indication of skin sensitization based on study results
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node and as a ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).
CLINICAL OBSERVATIONS:
No signs of systemic toxicity were observed for any animal in any dose group over the course of the test or the 3 day observation period after dosing.
BODY WEIGHTS
The body weight change of the dose group animals between day 1 and day 6 was comparable to that of the control group.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The results of the LLNA study (pooled-method) indicated that the test item is a skin sensitizer under the conditions of the test.
- Executive summary:
A GLP study was performed in accordance with OECD 429 using the pooled method. Groups of four female mice were dosed with 1, 2.5 and 5% solutions of the test item, reaction mass of mixed xylenes and sulphur monochloride. 25 µl of the dose solution was applied to the dorsal surface of each ear on three consecutive days. Clinical observations and body weights were recorded from days 1 -6. No effects on the body weight or signs of systemic toxicity were observed.
On day 6 the animals were administered with 3HTdR and 5 hours later the animals were necropsied. The auricular lymph nodes from all animals in each experimental group were excised and pooled.
The Stimulation Index (SI) was calculated for each dose group, an increase of threefold or greater in the 3HTdR incorporation compared to control values was considered a sensitizer. The SI values for the three dose groups 1, 2.5 and 5% were 0.94, 0.72 and 3.11 respectively. The test item is considered to be a 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.