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EC number: 919-489-5 | 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
Endpoint summary
Administrative data
Description of key information
The test substance was determined to be a weak skin sensitizer.
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:
- 2015-09-29 to 2015-10-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2010
- Deviations:
- yes
- Remarks:
- relative humidity was at times outside the protocol range. Study outcome was not affected.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- yes
- Remarks:
- relative humidity was at times outside the protocol range. Study outcome was not affected.
- 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
- Age at study initiation: young adult animals
- Weight at study initiation: 20.3 - 25.3 g
- Housing: 1-5 per cage in polycarbonate box with bedding
- Diet: PMI Feeds Inc., ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23
- Humidity (%): 35-92 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25 and 50 %
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS: No pre-test was performed.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: Stimulation index and EC3 -value
TREATMENT PREPARATION AND ADMINISTRATION:
The following test groups were included in the study: positive control, vehicle control, test group I (25 % test item), test group II (50 % test item), test group III (100 %). Each group consisted of 5 female CBA mice. The test animals received an open application of 25 µL of appropriate dilution (25 or 50 %, 100 %) of test item in the vehicle to the dorsum of both ears.
The vehicle group was treated with the vehicle only. The positive control group was treated with 100 % alpha-hexylcinnamaldehyde. All test and control animals were given a 2-day rest period on days 4 and 5.
On day 6, all animals were injected in the tail vein with 250 µL of 0.01 M phosphate-buffered saline (PBS), pH 7.4 at 25 °C containing 20 µCi of (methyl-3H)Thymidine. Five hours after injection, animals were sacrificed with an overdose of CO2, the draining auricular lymph nodes excised and pairs from each indicvidual animal processed.
A single cell suspension was prepared by mechanical disintegration through 200 mesh stainless steel gauze. Cells were washed twice and precipitated with 5 % trichloracetic acid. The pellets were resuspended in 1 mL TCA and transferred to 10 mL of scinitllation fluid. Incorporation of tritiated thymidine was measured by liquid scintillation counting as disintegrations per minute (DPM) from paired lymph nodes of each animal, and mean DPM/animal was calculated for each group. Background DPM values, determined by blanks, were automatically subtracted by the scintillation counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- A one-way parametric analysis of variance (ANOVA) with Dunnett's Multiple Comparison Test, using GraphPad InStat version 3.06 for Windows 95, GraphPad Software, San Diego California USA, was performed on DPM counts. If test groups showed a Stimulation Index (SI) of >3, then extrapolated EC3 was calculated from SI values at low % and either mid or high % concentrations per following formula:
If at least one concentration shows SI of <3, then the formula is: EC3 = c+ [3-d)/(b-d)] x (a-c)
where a = the dose concentration with higher SI;
b= the higher SI value
c= the dose concentration with lower SI,
d= the lower SI value using SI values closest to 3, one above and one below - Positive control results:
- The positive control item produced a stimulation index of >= 3, and is therefore considered a sensitizer.
- Key result
- Parameter:
- SI
- Value:
- 2.7
- Test group / Remarks:
- 25 % test substance concentration
- Key result
- Parameter:
- SI
- Value:
- 5.1
- Test group / Remarks:
- 50 % test substance concentration
- Key result
- Parameter:
- SI
- Value:
- 6.4
- Test group / Remarks:
- 100 % test substance concentration
- Key result
- Parameter:
- SI
- Value:
- 7.1
- Test group / Remarks:
- Positive control
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
For the 25 % test substance group the mean DPM count was 6366 (±3201). For the 50 % test substance group the mean DPM count was 12075 (±1487). For the 100 % test substance group the mean DPM count was 14998 (±4996). For the vehicle control group the mean DPM count was 2351 (±1895). For the positive control group the mean DPM count was 16498 (±5131).
EC3 CALCULATION
The extrapolated EC3 was 27.98 % using the 25 % and 50 % concentrations.
CLINICAL OBSERVATIONS:
All animals appeared to be normal for the study duration.
BODY WEIGHTS
All test group animals exhibited weight gain during the study. - Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The test substance produced a stimulation index >=3 in two groups of test animals, and is therefore considered a sensitizer. As the EC3 value was greater than 10 %, the substance was assessed as a weak sensitizer.
- Executive summary:
To assess the sensitizing potential of the test substance, a local lymph node assay in the mouse was conducted according to OECD 429. Three test groups consisted of 5 female CBA mice each. The animals received an open application of 25 µL of test item in the vehicle (25 or 50 %, 100 %) to both ears. All test and control (vehicle and positive) animals were given a 2-day rest period on days 4 and 5. On day 6, all animals were injected in the tail vein with 250 µL of 0.01 M phosphate-buffered saline containing 20 µCi of (methyl-3H)Thymidine. Five hours after injection, animals were sacrificed, the draining auricular lymph nodes excised and processed. Incorporation of tritiated thymidine was measured by liquid scintillation counting as disintegrations per minute (DPM) from paired lymph nodes of each animal, and mean DPM/animal was calculated for each group. As a result, the positive control item produced a stimulation index of >= 3, and is therefore considered a sensitizer. The test substance produced a stimulation index >=3 (27.98 %) in two groups (II and III) of test animals, and is therefore considered a sensitizer. As the EC3 value was greater than 10 %, the substance was assessed as a weak sensitizer.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline available
- GLP compliance:
- no
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- No LLNA study was available as the in vivo study was conducted in 1977, before the first version of the LLNA (OECD 429) was issued in 2002.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- 100, 30, 10, 3 %
- Day(s)/duration:
- 21 days
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- 3 %
- Day(s)/duration:
- on day 21
- No.:
- #2
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- 3 %
- Day(s)/duration:
- on day 35
- No.:
- #3
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- 3 %
- Day(s)/duration:
- on day 49
- No. of animals per dose:
- 6-8
- Details on study design:
- RANGE FINDING TESTS:
One day before the induction exposure the threshold-toxic concentration of the test material was estimated by applying the substance at the the test concentrations to the skin of guinea pigs. The minimal irritant and the maximal non irritant concentration were determined.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 21 (daily for 3 weeks)
- Exposure period: The test substance was applied uncovered and not washed off.
- Site: flank
- Frequency of applications: daily
- Concentrations: 100, 30, 10 and 3 %
B. CHALLENGE EXPOSURE
- No. of exposures: 3
- Day(s) of challenge: 21, 35 and 49
- Exposure period: The test substance was applied uncovered and not washed off.
- Site: contralateral flank
- Concentrations: 3 %
- Evaluation: Skin reactions were read after 24, 48 and 72 hours. - Challenge controls:
- 6-8 untreated or vehicle treated animals served as challenge control.
- Positive control substance(s):
- not required
- Key result
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 3
- Total no. in group:
- 6
- Clinical observations:
- no data
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The test substance was found to be a weak sensitizer in the OET in guinea pigs.
- Executive summary:
An open epicutaneous test using guinea pigs was performed to determine the skin sensitising property of the test substance. Therefore, 0.1 mL the test substance was applied at concentrations of 100, 30, 10 and 3 % to the clipped flanks of the test animals (6 -8 per group) daily for 3 weeks. The test site remained uncovered and the test material was not washed off. Skin reactions were read afterwards and the minimal irritant concentration was determined to be 3 %, the maximal non irritant concentration was 1 %. On days 21, 35 and 49 the challenge exposures (0.025 mL of the test substance at a concentration of 3 % and some lower concentrations) were applied to the skin. Skin reactions were evaluated 24, 48 and 72 hours afterwards. As a result, in half of the animals of the high dose induction group (100 % test substance concentration) positive skin reactions were observed. As a conclusion, the test substance was determined to be a weak skin sensitizer.
Referenceopen allclose all
Skin sensitization after daily application for three week
Concentration [%] |
Sensitization rate [Number of animals positive/total] |
||
Challenge on Day 21 |
Challenge on Day 35 |
Challenge on Day 49 |
|
100 |
3/6 |
3/6 |
2/6 |
30 |
0/6 |
0/6 |
0/6 |
10 |
0/6 |
0/6 |
0/6 |
3 |
0/6 |
0/6 |
0/6 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin sensitization
To assess the sensitizing potential of the test substance, a local lymph node assay in the mouse was conducted according to OECD 429. Three test groups consisted of 5 female CBA mice each. The animals received an open application of 25 µL of test item in the vehicle (25 or 50 %, 100 %) to both ears. All test and control (vehicle and positive) animals were given a 2-day rest period on days 4 and 5. On day 6, all animals were injected in the tail vein with 250 µL of 0.01 M phosphate-buffered saline containing 20 µCi of (methyl-3H)Thymidine. Five hours after injection, animals were sacrificed, the draining auricular lymph nodes excised and processed. Incorporation of tritiated thymidine was measured by liquid scintillation counting as disintegrations per minute (DPM) from paired lymph nodes of each animal, and mean DPM/animal was calculated for each group. As a result, the positive control item produced a stimulation index of >= 3, and is therefore considered a sensitizer. The test substance produced a stimulation index >=3 (EC3 27.98 %) in two groups (II and III) of test animals, and is therefore considered a sensitizer. As the EC3 value was greater than 10 %, the substance was assessed as a weak sensitizer.
An open epicutaneous test using guinea pigs was performed to determine the skin sensitising property of the test substance. Therefore, 0.1 mL of the test substance was applied at concentrations of 100, 30, 10 and 3 % to the clipped flanks of the test animals (6 -8 per group) daily for 3 weeks. The test site remained uncovered and the test material was not washed off. Skin reactions were read afterwards and the minimal irritant concentration was determined to be 3 %, the maximal non irritant concentration was 1 %. On days 21, 35 and 49 the challenge exposures (0.025 mL of the test substance at a concentration of 3 % and some lower concentrations) were applied to the skin. Skin reactions were evaluated 24, 48 and 72 hours afterwards. As a result, in half of the animals of the high dose induction group (100 % test substance concentration) positive skin reactions were observed. As a conclusion, the test substance was determined to be a weak skin sensitizer.
Conclusion:
Both the LLNA and the in vivo test in guinea pigs concluded that the test substance is a weak skin sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
Based on available data on skin sensitisation, the test item is classified for skin sensitisation into category 1B and labeled with H317 (May cause an allergic skin reaction) according to Regulation (EC) No 1272/2008 (CLP), as amended for the ninth time in Regulation (EU) No 2016/1179.
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