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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 928-226-3 | CAS number: 1179884-99-1
- 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://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 14 September 2009 and 30 September 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
- 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)
- Species:
- mouse
- Strain:
- other: CBA/Ca (CBA/CaOlaHsd)
- Sex:
- female
- Details on test animals and environmental conditions:
- Animals and Animal Husbandry
Female CBA/Ca (CBA/CaOlaHsd) strain mice were supplied by Harlan Laboratories UK Ltd., Bicester, Oxon, UK. On receipt the animals were randomly allocated to cages. The animals were nulliparous and non pregnant. After an acclimatisation period of at least five days the animals were selected at random and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card. At the start of the study the animals were in the weight range of 15 to 23 g, and were eight to twelve weeks old.
The animals were individually housed in suspended solid floor polypropylene cages furnished with softwood woodflakes. Free access to mains tap water and food (2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study.
The temperature and relative humidity were controlled to remain within target ranges of 19 to 25°C and 30 to 70%, respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06.00 to 18.00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study. - Vehicle:
- acetone/olive oil (4:1 v/v)
- Remarks:
- Please see below for Vehicle Determination Record
- Concentration:
- Each group was exposed to concentrations of 10% , 5% or 2.5% v/v (in acetone/olive oil 4:1)
- No. of animals per dose:
- Groups of four mice were treated
- Details on study design:
- Procedure
Preliminary Screening Test
Using available information regarding the systemic toxicity/irritancy potential of the test material, a preliminary screening test was performed using one mouse. The mouse was treated by daily application of 25 µl of the test material at a concentration of 10% w/w in acetone/olive oil 4:1, to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The mouse was observed twice daily on Days 1, 2 and 3 and once daily on Days 4, 5 and 6. Any signs of toxicity or excessive local irritation noted during this period were recorded. The bodyweight was recorded on Day 1 (prior to dosing) and on Day 6.
Main Test
Test Material Administration
Groups of four mice were treated with the test material at concentrations of 10%, 5% or 2.5% w/w in acetone/olive oil 4:1. The preliminary screening test suggested that the test material would not produce systemic toxicity or excessive local irritation at the highest suitable concentration. The mice were treated by daily application of 25 µl of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test material 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.
3H-Methyl Thymidine Administration
Five days following the first topical application of the test material (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):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- None provided.
- Positive control results:
- Methods. A group of five animals was treated with 50 µl (25 µl per ear) of α Hexylcinnamaldehyde as a solution in acetone/olive oil 4:1 at a concentration of 15% v/v. A further control group of five animals was treated with acetone/olive oil 4:1 alone. This control group was shared with Project
number 0673/0012.
Results.
The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of
the vehicle control group is as follows:
Concentration (% v/v) in
acetone/olive oil 4:1 Stimulation Index Result
15 3.70 Positive
Conclusion. α Hexylcinnamaldehyde was considered to be a sensitiser under the conditions of the test. - Parameter:
- SI
- Remarks on result:
- other: A stimulation index of less than 3 was recorded for the test material at concentrations of 10%, 5% and 2.5% v/v in acetone/olive oil 4:1. The stimulation index (SI) results are given in Table 2 - see section any other information on results.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: The radioactive disintegrations per minute (dpm) per lymph node and the stimulation index (SI) are given in Table 2- see section any other information on results.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material was considered to be a non-sensitiser under the conditions of the test.
- Executive summary:
Introduction.
A study was performed to assess the skin sensitisation potential of the test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was designed to meet the requirements of the following:
OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay" (adopted 24 April 2002)
Method B42 Skin Sensitisation (Local Lymph Node Assay) of CommissionRegulation (EC) No. 440/2008
Methods.
Following a preliminary screening test in which no clinical signs of toxicity were noted at a maximum attainable 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 material as asuspension/emulsioninacetone/olive oil 4:1at concentrations of 10%, 5% or 2.5% w/w. A further group of four animals was treated withacetone/olive oil 4:1alone.
Results.
The Stimulation Index 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
acetone/olive oil 4:1Stimulation Index
Result
2.5
1.12
Negative
5
1.00
Negative
10
0.86
Negative
Conclusion.
The test material was considered to be a non-sensitiser under the conditions of the test.
Reference
Concentration (%w/w) in |
Animal Number |
Bodyweight (g) |
Day |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Day 1 |
Day 6 |
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
|||||
10 |
S-1 |
21 |
21 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 = No signs of systemic toxicity
Table 2 Disintegrations per Minute, Disintegrations per Minute/Node and Stimulation Index
Concentration |
dpm |
dpm/Nodea |
Stimulation Indexb |
Result |
Vehicle |
12222.07 |
1527.76 |
na |
na |
2.5 |
13722.06 |
1715.26 |
1.12 |
Negative |
5 |
12251.10 |
1531.39 |
1.00 |
Negative |
10 |
10496.22 |
1312.03 |
0.86 |
Negative |
dpm = Disintegrations per minute
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
Table 3 Individual Clinical Observations and Mortality Data
Concentration |
Animal Number |
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
|||
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
|||||
Vehicle |
1-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.5 |
2-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
3-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
10 |
4-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 = No signs of systemic toxicity
Table 4 Individual Bodyweights and Bodyweight Changes
Concentration |
Animal Number |
Bodyweight (g) |
Bodyweight Change (g) |
|
Day 1 |
Day 6 |
|||
Vehicle |
1-1 |
19 |
18 |
-1 |
1-2 |
18 |
19 |
1 |
|
1-3 |
18 |
18 |
0 |
|
1-4 |
19 |
19 |
0 |
|
2.5 |
2-1 |
20 |
21 |
1 |
2-2 |
18 |
18 |
0 |
|
2-3 |
19 |
19 |
0 |
|
2-4 |
17 |
18 |
1 |
|
5 |
3-1 |
19 |
19 |
0 |
3-2 |
19 |
19 |
0 |
|
3-3 |
18 |
19 |
1 |
|
3-4 |
22 |
21 |
-1 |
|
10 |
4-1 |
18 |
18 |
0 |
4-2 |
21 |
21 |
0 |
|
4-3 |
20 |
19 |
-1 |
|
4-4 |
18 |
17 |
-1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A skin sensitisation test to OECD test guideline 429 and to acceptable quality standards show that the registered substance in its isolated form is non-sensitising under the conditions of the test.
Justification for selection of skin sensitisation endpoint:
GLP compliant guideline study with a klimisch score of 1
Justification for classification or non-classification
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)