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EC number: 237-331-7 | CAS number: 13749-61-6
- 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
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 perfonned between 12 November 2007 and 05 December 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
- 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:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Female CBA/Ca (CBA/CaOlaHsd) strain mice were supplied by Harlan UK Limited
- Age at study initiation: Eight to twelve weeks old.
- Weight at study initiation: Weight range of 15 to 23 g.
- Housing: The animals were individually housed in suspended solid-floor polypropylene cages furnished with softwood wood flakes.
- Diet (e.g. ad libitum): Free access to mains tap water was allowed throughout the study.
- Water (e.g. ad libitum): Free access to food (Certified Rat and Mouse Diet) was allowed throughout the study.
- Acclimation period: At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Controlled to remain within target range of 19 to 25°C.
- Humidity (%): Controlled to remain within target range of 30 to 70%.
- Air changes (per hr): Approximately fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): Controlled by a time switch to give twelve hours continous light (06.00 to 18.00) andd twelve hours darkness. - Vehicle:
- dimethylformamide
- Remarks:
- For the purpose of the study, the test material was freshly prepared in dimethyl formamide. This vehicle was chosen as it produced the highest concentration that was suitable for dosing.
- Concentration:
- Main test: test material at concentrations of 5%, 10% or 25% v/v in dimethyl formamide.
- No. of animals per dose:
- Groups of four mice per dose.
- Details on study design:
- PRELIMINARY SCREENING TEST:
As no toxicological information was available 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 25% v/v in dimethyl formamide, 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 of the mouse 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 5%, 10% or 25% v/v in dimethyl formamide. 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) giving a total of 20 µCi to each mouse.
OBSERVATIONS:
CLINICAL OBSERVATIONS:
All animals were observed twice daily on Days I, 2 and 3 and on a daily basis on Days 4, 5 and 6. Any signs of toxicity or signs of ill health during the test were recorded.
BODYWEIGHTS:
The bodyweight of each mouse was recorded on Day 1 (prior to dosing) and Day 6 (prior to termination).
TERMINAL PROCEDURES:
TERMINATION:
Five hours following the administration of 3HTdR all mice were killed by carbon dioxide asphyxiation. The draining auricular lymph nodes from the four mice were excised and pooled for each experimental group. For each group 1 ml of PBS was added to the pooled lymph nodes.
PREPARATION OF SINGLE CELL SUSPENSION:
A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through a 200-mesh stainless steel gauze. The lymph node cells were rinsed through the gauze with 4 ml of PBS into a petri dish labelled with the project number and dose concentration. The lymph node cell suspension was transferred to a centrifuge tube. The petri dish was washed with an additional 5 ml of PBS to remove all remaining lymph node cells and these were added to the centrifuge tube. The pooled lymph node cells were pelleted at 1400 rpm (approximately 190 g) for ten minutes. The pellet was resuspended in 10 ml of PBS and re-pelleted. To precipitate out the radioactive material, the pellet was resuspended in 3 ml of 5% Trichloroacetic acid (TCA).
DETERMINATION OF 3HTdR INCORPORATION:
After approximately eighteen hours incubation at approximately 4°C, the precipitates were recovered by centrifugation at 2100 rpm (approximately 450 g) for ten minutes, re-suspended in 1 ml of TCA and transferred to 10 ml of scintillation fluid (Optiphase 'Trisafe'). 3HTdR incorporation was measured by ß-scintillation counting. The "Poly Q" vials containing the samples and scintillation fluid were placed in the sample changer of the scintillator and left for approximately twenty minutes. The purpose of this period of time in darkness was to reduce the risk of luminescence, which has been shown to affect the reliability of the results. After approximately twenty minutes, the vials were shaken vigorously. The number of radioactive disintegrations per minute was then measured using the Beckman LS6500 scintillation system. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- Three groups, each of five animals, were treated with 50 µl (25 µl per ear) of α-Hexylcinnamaldehyde, Tech, 85% as a solution in dimethyl formamide at concentrations of 5%, 10% and 25% v/v. A further control group of five animals was treated with dimethyl formamide alone.
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 (% v/v) in demethyl formamide: 5
Stimulation Index: 2.11
Result: Negative
Concentration (% v/v) in demethyl formamide: 10
Stimulation Index: 2.82
Result: Negative
Concentration (% v/v) in demethyl formamide: 25
Stimulation Index: 6.37
Result: Positive
α-Hexylcinnamaldehyde, Tech, 85% was considered positive under the conditions of the test. - Parameter:
- SI
- Value:
- 1.23
- Test group / Remarks:
- 5 %, 5 animals
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 25 %, 5 animals
- Parameter:
- SI
- Value:
- 1.77
- Test group / Remarks:
- 10 %, 5 animals
- Interpretation of results:
- GHS criteria not met
- 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 Commission Directive 2004173/EC
Methods.
Following a preliminary screening test, three groups, each of four animals, were treated with 50 µl (25 µl per ear) of the test material as a solution in dimethyl formamide at concentrations of 5%, 10% or 25% v/v. A further group of four animals was treated with dimethyl formamide alone.
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 (% v/v) in dimethyl formamide
Stimulation Index
Result
5
1.23
Negative
10
1.77
Negative
25
1.00
Negative
Conclusion.
The test material was considered to be a non-sensitiser under the conditions of the test.
Reference
Preliminary Screening Test:
Clinical observations, bodyweight and mortality data are given in Table 1.
No signs of systemic toxicity were noted.
Based on this information the dose levels selected for the main test wer 5%, 10% and 25% v/v in dimethyl formamide.
Clinical Observations and Mortality Data:
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.
Bodyweight:
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.
Table 1: Clinical Observations, Bodyweight and Mortality Data – Preliminary Screening Test
Concentration (% v/v) in dimethyl formamide |
Animal number |
Bodyweight (g) |
Day |
|||||||||
Day 1 |
Day 6 |
1 |
2 |
3 |
4 |
5 |
6 |
|||||
Pre-dose |
Post dose |
Pre-dose |
Post dose |
Pre-dose |
Post dose |
|||||||
25 |
S-1 |
19 |
19 |
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 (% v/v) in dimethyl formamide |
Dpm |
Dpm/Nodea |
Stimulation Indexb |
Result |
Vehicle |
3596.38 |
449.55 |
na |
na |
5 |
4410.37 |
551.30 |
1.23 |
Negative |
10 |
6348.28 |
793.54 |
1.77 |
Negative |
25 |
3610.40 |
451.30 |
1.00 |
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
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 Commission Directive 2004173/EC
Methods.
Following a preliminary screening test, three groups, each of four animals, were treated with 50 µl (25 µl per ear) of the test material as a solution in dimethyl formamide at concentrations of 5%, 10% or 25% v/v. A further group of four animals was treated with dimethyl formamide alone.
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 (% v/v) in dimethyl formamide
Stimulation Index
Result
5
1.23
Negative
10
1.77
Negative
25
1.00
Negative
Conclusion.
The test material was considered to be a non-sensitiser under the conditions of the test.
Migrated from Short description of key information:
The test material was considered to be a non-sensitiser under the conditions of the test.
Justification for selection of skin sensitisation endpoint:
The study has been conducted according to OECD Guideline 429 and GLP and is adequately reported. The study has been assigned a reliability 1.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In view of the results from an OECD 429 "Skin Sensitisation: Local Lymph Node Assay" study, under these experimental conditions, the test item is not a skin sensitiser as the Stimulation Index was below 3 at all concentrations test.
In accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures, the test item must not be classified. No hazard statement or signal word is required.
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