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Diss Factsheets
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EC number: 244-311-1 | CAS number: 21282-97-3
- 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:
- 15 December - 11 January 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study conduct in accordance with international guidelines.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Test material form:
- other: Colourless to yellowish clear liquid
- Details on test material:
- - Name of test material (as cited in study report): LZ649
- Physical state: Colourless to yellowish clear liquid
- Expiration date of the lot/batch: 23 November 2014
- Storage condition of test material: Room temperature in the dark, desiccated
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: a reputable supplier
- Age at study initiation:10-11 weeks
- Weight at study initiation: 17.4 to 21.2 g
- Housing: animals were housed two animals per cage, in solid bottomed polycarbonate cages with a stainless steel mesh lid. Each cage contained a quantity of autoclaved wood flake bedding, additionally Nestlets and a plastic shelter were included for environmental enrichment.
- Diet (e.g. ad libitum): The animals were allowed free access to a standard rodent diet (Rat and Mouse No. 1 Maintenance Diet). This diet contained no added antibiotic or other chemotherapeutic or prophylactic agent.
- Water (e.g. ad libitum): Potable water taken from the public supply was freely available via polycarbonate bottles fitted with sipper tubes.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 40 to 70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): Artificial lighting was controlled to give a cycle of 12 hours continuous light and 12 hours continuous dark per 24 hours.
IN-LIFE DATES: From: 1st December 2011 To: 3rd January 2012
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50% v/v and As supplied main test
- No. of animals per dose:
- No preliminary test required
4 main test - Details on study design:
- RANGE FINDING TESTS:
The maximum practical concentration for dermal administration (using a micropipette) of the test substance prepared in acetone:olive oil (4:1) was assupplied. Available toxicity and irritancy information indicated this would be a suitable high concentration for the study therefore no preliminary
investigations were performed. The low and intermediate concentrations were selected from the concentration series given in regulatory guidelines
and the concentrations administered were:
25, 50% v/v or As supplied in acetone:olive oil (4:1)
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: The animals were allocated without conscious bias to cages within the treatment groups.
- Criteria used to consider a positive response: Results for each treatment group were expressed as the Stimulation Index (SI), derived by dividing the mean dpm/mouse for each treated group and the positive control group by the mean dpm/mouse in the vehicle control group. If the SI is 3 or more, the test substance is regarded as a skin sensitizer.
TREATMENT PREPARATION AND ADMINISTRATION:
The test substance, LZ649, was prepared for administration as a series of graded concentrations in the vehicle, by direct dilution.
The test substance was used as supplied and all formulations were prepared on the day of dosing at the required concentration(s).
The absorption of the test substance was not determined.
In the main phase of the study, five days following the first topical application of test substance (Day 6) all mice were injected via the tail vein with 250 µL of phosphate buffered saline containing 3H-methyl Thymidinea (3HTdR: 80 µCi/mL) giving a nominal 20 µ0Ci to each mouse. The injection into
the tail vein was carried out using a plastic syringe and needle after the mouse had been heated in a warming chamber. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Not applicable
Results and discussion
- Positive control results:
- The SI for the positive control substance hexyl cinnamic aldehyde (HCA), was 8.4 which demonstrates the validity of this study.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- concentration as supplied
- Parameter:
- SI
- Value:
- 1.6
- Test group / Remarks:
- concentration 25% v/v
- Parameter:
- SI
- Value:
- 1.7
- Test group / Remarks:
- concentration 50% v/v
Any other information on results incl. tables
PRELIMINMARY TEST
The maximum practical concentration for dermal administration (using a micropipette) of the test substance prepared in acetone:olive oil (4:1) was as supplied. Available toxicity and irritancy information indicated this would be a suitable high concentration for the study therefore no preliminary investigations were performed.
MAIN TEST
There were no deaths and no signs of ill health or toxicity were observed during this study.
No signs of dermal irritation were seen on the ears during the study. There was no indication of an effect of treatment on bodyweight gain.
Concentration |
dpm |
No. lymph nodes per group |
Dpm/node |
Stimulation index* |
Result - = negative |
AOO |
6153.80 |
8.0 |
769.23 |
n/a |
n/a |
25% v/v |
9737.50 |
8.0 |
1217.19 |
1.6 |
- |
50% v/v |
10584.30 |
8.0 |
1323.04 |
1.7 |
- |
As supplied |
7964.90 |
8.0 |
995.61 |
1.3 |
- |
HCA 25% v/v |
51437.70 |
8.0 |
6429.71 |
8.4 |
+ |
* Stimulation
Index of 3 or more indicates a positive result
n/a not
applicable
dpm disintegrations
per minute
AOO acetone:olive
oil (4:1 v/v) vehicle control
HCA hexyl cinnamic aldehyde (positive control)
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LZ649 is not regarded as a potential skin sensitizer.
- Executive summary:
The LLNA study was performed between December 2011 and January 2012 according to OECD Guideline 429 and GLP.
There were no deaths and no signs of ill health or toxicity were observed during this study. No signs of dermal irritation were seen on the ears during the study. There was no indication of an effect of treatment on bodyweight gain.
The SI (test/control ratios) obtained for 25, 50% v/v or as supplied LZ649 were 1.6, 1.7 or 1.3 respectively. As a SI of 3 or more was not recorded for any of the concentrations tested, LZ649 is not considered to have the potential to cause skin sensitization.
The SI for the positive control substance hexyl cinnamic aldehyde (HCA) was 8.4 which demonstrates the validity of this study.
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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