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EC number: 610-204-7 | CAS number: 446299-90-7
- 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
Skin sensitisation (in chemico): First key event (molecular initiating event): Data waiving. Preliminary to the study, in accordance with OECD Guideline 442C the solubility at 100 mM was assessed in all required solvents. It was not possible to obtain a solution homogeneous and stable enough for any of the solvents. Thus, the test item could not be tested in accordance with the DPRA method.
Skin sensitisation (in vitro): Second key event (activation of keratinocytes): Data waiving. Preliminary to the study, in accordance with OECD Guideline 442D the solubility was assessed in all required solvents and diffferent concentrations in culture medium. It was not possible to obtain a solution homogeneous and stable enough for any of the solvents and conditions. Thus, the test item could not be tested in accordance with the KeratinoSens assay.
Skin sensitisation (in vitro): Third key event (activation of dendritic cells): Data waiving. This test was not performed because the available method (OECD TG 442E) addressing this key event tends to produce false negatice results with substances with a Log Kow greater than 3.5, as it is the case with the substance under consideration.
Skin sensitisation (in vivo): Key study. Test method according to the OECD 442B Guideline with GLP. Under the experimental conditions the test item does not have to be classified as a skin sensitizer using the LLNA assay. The Stimulation Index (SI) calculated by individual approach was 0.86, 0.99 and 0.96 for the treated groups at 20%, 40%, 60%, respectively.
Conclusion: As it was not possible to perform the in vitro/in chemico tests addressing all the three key events required in column 1 of REACH Annex VII, it was necessary to conduct an in vivo LLNA assay according to column 2 of REACH Annex VII. Based on the results of the in vivo assay, the test substance does not need to be classified as 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:
- 09.12.2020 - 22.12.2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin sensitisation: Local Lymph Node Assay: BrdU-ELISA or –FCM)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.51 (Skin Sensitisation: Local Lymph Node Assay: BrDU-ELISA)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
- Species:
- mouse
- Strain:
- CBA:J
- Remarks:
- CBA/JRj
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elevage Janvier Labs (F-53941Le Genest Saint Isle).
- Females (if applicable) nulliparous and non-pregnant: yes.
- Age at study initiation: 8-9 weeks old.
- Weight at study initiation: 20.2-25.0 g (treated groups and control group)
- Housing: The animals were individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes.
- Diet: Teklad Global 16% Protein Rodent Diet (ENVIGO 2016) ad libitum
- Water: tap water from public distribution system ad libitum. Microbiological and chemical analyses of the water were carried out once every six months by Bureau Veritas - Eurofins (FRANCE).
- Acclimation period: at least five days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25ºC
- Humidity (%): 30-70%
- Air changes (per hr): at least ten changes per hour
- Photoperiod (hrs dark / hrs light): 12 h light (7.00 to 19.00) / 12 h darkness - Vehicle:
- propylene glycol
- Concentration:
- 60%, 40% and 20%.
- No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS:
As no information was available regarding irritant potential or systemic toxicity of the test item in the mouse, a preliminary screening test was performed using one mouse with the highest technically possible concentration. The mouse was treated by daily application of 25 μL of the test item diluted at 60% in PG to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The mouse was observed daily from day 1 to day 6. Ear thickness was recorded on day 1, day 3 and on day 6. The bodyweight of the mouse was recorded on Day 1 (prior to dosing) and on Day 6.
- Compound solubility: Not specified
- Irritation: No sign of excessive irritation was noted at the tested concentration of 60%.
- Systemic toxicity: No mortality was noted at the tested concentrations of 60%.
- Ear thickness measurements: values were within the acceptable range.
- Erythema scores: 0 (no sign of erythema)
MAIN STUDY:
-Three groups of four mice each were treated with the test item diluted at 60%, 40% and 20% in PG. A further group of four mice received the vehicle alone. All four groups of mice were treated by daily application of 25 μL of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days (Days 1, 2 and 3).
-Clinical Observations and mortality: All animals were observed daily on Days 1, 2, 3, 4, 5 and 6. Any signs of toxicity or signs of ill health during the test were recorded.
-Body weights: The bodyweight of each mouse was recorded on Day 1 (prior to dosing) and Day 6 (prior to termination)
-Ear thickness measurements and recording of local reactions: On day 1 and on day 3 (before application) as well as on day 6 (after sacrifice) of each experiment, the thickness of the right ear of each animal of the vehicle control and treated groups was measured by a micrometer. Furthermore, on day 6, punch biopsies of 8 mm in diameter of the apical area of both ears were prepared and weighed in order to assess the irritation potential of the test item and the two lymph nodes per mouse were weighed.
- Stimulation index (SI) determination: BrdU was measured by ELISA using a commercial kit. Briefly, 100 μL of the LNC suspension was added to the wells of a flat-bottom microplate at least in triplicate. After fixation and denaturation of the LNC, anti-BrdU antibody was added to each well and allowed to react. Subsequently the anti-BrdU antibody was removed by washing and the substrate solution was then added and allowed to produce chromogen. After 5 to 30 min, 30 μL of 1 M H2SO4 was added in each well, then shaken for one minute. Absorbance at 450 nm with a reference wavelength of 690 nm was then measured.
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: Results for each treatment group are expressed as the mean SI. The SI was derived by dividing the mean BrdU labelling index/mouse within each test group by the mean BrdU labelling index for the control group.
The BrdU labelling index was defined as:
BrdU labelling index = (ABSem – ABS blankem) – (ABSref – ABS blankref)
The test item will be regarded as a sensitiser if at least one concentration of the test item results is greater than 1.6 compared to control values.
-Determination of the EC1.6 value (theoretical concentration resulting in a SI value of 1.6): It was determined by linear interpolation of points on the dose-response curve, immediately above and below the 1.6-fold threshold. The equation used for calculation of EC1.6 was:
EC1.6 = c + [(1.6 – d) / (b – d)] x (a – c)
Legend: a = the lowest concentration giving stimulation index > 1.6
b = the actual stimulation index caused by a
c = the highest concentration failing to produce a stimulation index of 1.6
d = the actual stimulation index caused by c
According to Regulation (EC) No. 286/2011, the positive test item will be classified in subcategory 1A or 1B in accordance with:
If the EC value ≤ 2, the test item will be classified in "sub-category 1A".
If the EC value > 2, the test item will be classified in "sub-category 1B".
TREATMENT PREPARATION AND ADMINISTRATION
-Three groups of four mice each were treated with the test item diluted at 60%, 40% and 20% in PG. A further group of four mice received the vehicle alone. All four groups of mice were treated by daily application of 25 μL of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days (Days 1, 2 and 3). The test item 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.
- On day 5, 0.5 mL (5 mg/mouse) of BrdU (10 mg/mL) solution was injected by intra-peritoneal route. The BrdU solution was prepared by weighing 177.70 mg of 5-bromo-2'-deoxyuridine in a glass sample bottle and adding 17.77 mL of physiological saline. The preparation was then stirred by ultraturrax for 34 minutes just before the administration to obtain a colourless solution.
-On day 6 (end of the test), the animals were euthanized with sodium pentobarbital (Dolethal®).
The draining auricular lymph nodes from the four mice were excised.
-From each mouse, a single-cell suspension of lymph node cells (LNC) excised bilaterally was prepared by gentle mechanical disaggregation through a disposable plastic pestle to crush the lymph nodes followed by passage through a #70 nylon mesh in 15 mL of DPBS (Ca2+ / Mg2+ - free) into a well of a multi-well 6. The optimized volume was based on achieving a mean absorbance of the negative control group within 0.1- 0.2. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- EC1.6= 18.69%. Under the experimental conditions tested, the positive control substance has to be classified in category 1 “Skin sensitisation”, in accordance with the Regulation (EC) No. 1272/2008.
- Key result
- Parameter:
- SI
- Value:
- 0.86
- Test group / Remarks:
- 20%
- Key result
- Parameter:
- SI
- Value:
- 0.99
- Test group / Remarks:
- 40%
- Key result
- Parameter:
- SI
- Value:
- 0.96
- Test group / Remarks:
- 60%
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
No increase in ear thickness and in ear weight was noted in animals treated at 20%, 40%, 60% respectively.
DETAILS ON STIMULATION INDEX CALCULATION
No stimulation index higher than 1.6 was recorded whatever the tested concentration. The Stimulation Index (SI) calculated by individual approach was 0.86, 0.99 and 0.96 for the treated groups at 20%, 40%, 60%, respectively.
EC3 CALCULATION
The EC1.6 cannot be determined due to the absence of SI value higher than 1.6.
CLINICAL OBSERVATIONS:
No mortality was noted in the test and control animals during the test.
No signs of systemic toxicity were noted in the test animals treated at 20%, 40%, 60% and control animals during the test.
BODY WEIGHTS
No change in body weight was noted for all treated groups versus control group. - Interpretation of results:
- other: Not classified (Regulation EC No. 1272/2008)
- Conclusions:
- The Stimulation Index (SI) calculated by individual approach in the in vivo LLNA assay was 0.86, 0.99 and 0.96 for the treated groups at 20%, 40%, 60%, respectively. Therefore, the test item is classified as non-sensitiser.
- Executive summary:
The skin sensitisation potential of the test item was tested in the LLNA assay according to OECD 442B and E.U. B.51 method, under GLP conditions. A preliminary screening test was performed using one mouse (CBA:J) that was treated by daily application of 25 μL of the test item diluted at 60% in propylene glycol to the dorsal surface of each ear for three consecutive days. Neither mortality nor sign of excessive irritation was noted at the tested concentration of 60%. Therefore, 60% was chosen as the highest concentration for the main study. Three groups of four female mice each were treated with the test item diluted at 60%, 40% and 20% in propylene glycol (vehicle) and a fourth one of four mice received the vehicle alone. On day 5, 0.5 mL of BrdU solution (10mg/mL) was injected by intraperitoneal route. On day 6, the proliferation of lymphocytes in the draining auricular lymph nodes was determined by measurement of BrdU content in DNA of lymphocyte using an ELISA kit. A positive control study using alpha-hexylcinnamaldehyde was also performed, leading to a EC1.6 value of 18.69% (skin sensitiser, category 1).
No mortality was noted in the test and control animals during the test. No signs of systemic toxicity were noted in the test animals treated at 60%, 40%, 20% and control animals during the test and no statistical significant change in body weight was noted for all treated groups versus control group. No stimulation index higher than 1.6 was recorded whatever the tested concentrations.
The Stimulation Index (SI) calculated by individual approach was 0.96, 0.99 and 0.86 for the treated groups at 60%, 40%, 20%, respectively. No increase in ear thickness and in ear weight was noted in animals treated with the test item. Therefore, the test item has to be considered as not excessively irritant at these concentrations and the test item does not have to be classified as a skin sensitiser, in accordance with the Regulation EC No. 1272/2008.- Endpoint:
- skin sensitisation: in chemico
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
Preliminary to the study, in accordance with OECD Guideline 442C the solubility at 100 mM was assessed in all required solvents. It was not possible to obtain a solution homogeneous and stable enough for any of the solvents. Thus, the test item cannot be tested in accordance with the DPRA method. See attached a summary of this preliminary solubility test. - Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
Preliminary to the study, in accordance with OECD Guideline 442D the solubility of the test item was assessed in all required solvents and different concentrations in culture medium. It was not possible to obtain a solution homogeneous and stable enough for any of the solvents and conditions. Thus, the test item cannot be tested in accordance with the Keratino Sens assay. See attached a summary of this preliminary solubility test. - Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because the available in vitro test methods are not applicable for the substance and therefore an in vivo skin sensitisation study was conducted
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
According to column 2 of REACH Annex VII, the available in vitro test method addressing the key event activation of dentritic cells (h-CLAT method, OECD TG 442E) is not applicable for this substance because it tends to produce false negative results with substances with a Log Kow greater than 3.5, as it is the case with the substance under consideration. - Reason / purpose for cross-reference:
- data waiving: supporting information
Referenceopen allclose all
Table 1. Results of the preliminary test at 60% concentration of the test item.
Concentration % | Animal | Bodyweight (g) | Day | ||||||
Day 1 | Day 6 | 1 | 2 | 3 | 4 | 5 | 6 | ||
60% | Sf3214 | 21.0 | 22.5 | 0 | 0 | 0 | 0 | 0 | 0 |
N.t.R. | N.t.R | N.t.R | N.t.R | N.t.R | N.t.R |
0: no sign of erythema, N.t.R.: Nothing to report (no sign of systemic toxicity)
ANIMAL | Ear thickness (mm) on day 1 | Ear thickness (mm) on day 3 | Ear thickness (mm) on day 6 | Ear weight (mg) on day 6 | Weight Lymph nodes (mg) | Excessive irritation |
Sf3214 | 0.21 | 0.21 | 0.22 | 34.4 | 11.0 | No |
Table 2. Clinical observations and mortality data for test and control animals
1 | PG | Sf 3218 Sf 3219 Sf 3220 Sf 3221 | 0 | 0 | 0 | 0 | 0 | 0 |
0 | 0 | 0 | 0 | 0 | 0 | |||
0 | 0 | 0 | 0 | 0 | 0 | |||
0 | 0 | 0 | 0 | 0 | 0 | |||
2 | 20% | Sf 3243 Sf 3244 Sf 3245 Sf 3246 | 0 | 0 | 0 | 0 | 0 | 0 |
0 | 0 | 0 | 0 | 0 | 0 | |||
0 | 0 | 0 | 0 | 0 | 0 | |||
0 | 0 | 0 | 0 | 0 | 0 | |||
3 | 40% | Sf 3248 Sf 3249 Sf 3250 Sf 3251 | 0 | 0 | 0 | 0 | 0 | 0 |
0 | 0 | 0 | 0 | 0 | 0 | |||
0 | 0 | 0 | 0 | 0 | 0 | |||
0 | 0 | 0 | 0 | 0 | 0 | |||
4 | 60% | Sf 3253 Sf 3254 Sf 3255 Sf 3256 | 0 | 0 | 0 | 0 | 0 | 0 |
0 | 0 | 0 | 0 | 0 | 0 | |||
0 | 0 | 0 | 0 | 0 | 0 | |||
0 | 0 | 0 | 0 | 0 | 0 |
0: no sign of erythema
Groups | Test item | AnimalsNo. | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 |
1 | PG | Sf 3218 Sf 3219 Sf 3220 Sf 3221 | N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | N.t.R |
N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | |||
N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | |||
N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | |||
2 | 20% | Sf 3243 Sf 3244 Sf 3245 Sf 3246 | N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | N.t.R |
N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | |||
N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | |||
N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | |||
3 | 40% | Sf 3248 Sf 3249 Sf 3250 Sf 3251 | N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | N.t.R |
N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | |||
N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | |||
N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | |||
4 | 60% | Sf 3253 Sf 3254 Sf 3255 Sf 3256 | N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | N.t.R |
N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | |||
N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | |||
N.t.R | N.t.R | N.t.R | N.t.R | N.t.R | N.t.R |
N.t.R.: Nothing to report (no sign of systemic toxicity)
Table 3. Individual bodyweights and bodyweight changes for test and control animals
Groups | Test item | Animals No. | Bodyweight (g) | Body weight gain (g) | |
Day 1 | Day 6 | ||||
1 | PG | Sf 3218 | 23.0 | 23.2 | 0.2 |
Sf 3219 | 20.9 | 21.1 | 0.2 | ||
Sf 3220 | 21.8 | 22.8 | 1.0 | ||
Sf 3221 | 23.7 | 23.5 | -0.2 | ||
MEAN | 22.4 | 22.7 | 0.3 | ||
Standard-deviation | 1.2 | 1.1 | 0.5 | ||
2 | 20% | Sf 3243 | 25.0 | 25.0 | 0.0 |
Sf 3244 | 20.8 | 22.3 | 1.5 | ||
Sf 3245 | 21.5 | 22.5 | 1.0 | ||
Sf 3246 | 19.5 | 20.1 | 0.6 | ||
MEAN | 21.7 | 22.5 | 0.8 | ||
Standard-deviation | 2.4 | 2.0 | 0.6 | ||
3 | 40% | Sf 3248 | 22.0 | 22.1 | 0.1 |
Sf 3249 | 22.4 | 23.3 | 0.9 | ||
Sf 3250 | 22.2 | 22.5 | 0.3 | ||
Sf 3251 | 22.2 | 22.7 | 0.5 | ||
MEAN | 22.2 | 22.7 | 0.5 | ||
Standard-deviation | 0.2 | 0.5 | 0.3 | ||
4 | 60% | Sf 3253 | 20.6 | 23.0 | 2.4 |
Sf 3254 | 21.5 | 22.1 | 0.6 | ||
Sf 3255 | 23.4 | 24.0 | 0.6 | ||
Sf 3256 | 20.2 | 19.1 | -1.1 | ||
MEAN | 21.4 | 22.1 | 0.6 | ||
Standard-deviation | 1.4 | 2.1 | 1.4 |
Table 4. Results of the proliferation assay (1/2)
Groups | Test item | BrdU-index (mean*) | Stimulation Index SI (mean + standard deviation) | Result | EC1.6 value |
1 | PG | 0.621 | n.a | n.a | n.a. |
2 | 20% | 0.531 | 0.86 ± 0.12 | negative | n.a. |
3 | 40% | 0.617 | 0.99 ± 0.08 | negative | |
4 | 60% | 0.598 | 0.96 ± 0.19 | negative |
Table 5. Results of the proliferation assay (2/2)
Groups | Test item | Animal No. | BrdU-index (DO Indiv) | BrdU-index (DO mean) | BrdU-index mean* | Stimulation Index S.I. (indiv ± Standard deviation) |
1 | PG | Sf 3218 | 0.633 0.599 0.572 | 0.602 | 0.621 | n.a |
Sf 3219 | 0.749 0.939 0.440 | 0.710 | n.a | |||
Sf 3220 | 0.715 0.424 0.586 | 0.575 | n.a | |||
Sf 3221 | 0.639 0.640 0.504 | 0.595 | n.a | |||
2 | 20% | Sf 3243 | 0.313 0.588 0.653 | 0.518 | 0.531 | 0.83 ± 0.29 |
Sf 3244 | 0.728 0.559 0.510 | 0.599 | 0.97 ± 0.18 | |||
Sf 3245 | 0.477 0.747 0.512 | 0.579 | 0.93 ± 0.24 | |||
Sf 3246 | 0.516 0.356 0.418 | 0.429 | 0.69 ± 0.13 | |||
3 | 40% | Sf 3248 | 0.534 0.485 0.879 | 0.633 | 0.617 | 1.02 ± 0.35 |
Sf 3249 | 0.623 0.570 0.647 | 0.614 | 0.99 ± 0.06 | |||
Sf 3250 | 0.681 0.656 0.665 | 0.669 | 1.08 ± 0.02 | |||
Sf 3251 | 0.674 0.423 0.556 | 0.551 | 0.89 ± 0.20 | |||
4 | 60% | Sf 3253 | 0.465 0.690 0.475 | 0.544 | 0.598 | 0.88 ± 0.20 |
Sf 3254 | 0.342 0.728 0.396 | 0.490 | 0.79 ± 0.34 | |||
Sf 3255 | 0.568 0.623 0.587 | 0.594 | 0.96 ± 0.05 | |||
Sf 3256 | 0.708 0.808 0.775 | 0.763 | 1.23 ± 0.08 |
Table 6. Individual ear thickness and irritation level
Groups | Test item | Animals No. | Day 1 ear thickness (mm) | Day 3 ear thickness (mm) | Day 6 ear thickness (mm) | Ear thickness increase D3/D1 (%) | Ear thickness increase D6/D1 (%) | |
1 | PG | Sf | 3218 | 0.21 | 0.20 | 0.20 | -4.8 | -4.8 |
Sf | 3219 | 0.20 | 0.21 | 0.19 | 5.0 | -5.0 | ||
Sf | 3220 | 0.20 | 0.21 | 0.21 | 5.0 | 5.0 | ||
Sf | 3221 | 0.21 | 0.21 | 0.21 | 0.0 | 0.0 | ||
MEAN | 0.21 | 0.21 | 0.20 | 1.31 | -1.19 | |||
Standard-deviation | 0.01 | 0.00 | 0.01 | 4.68 | 4.73 | |||
2 | 20% | Sf | 3243 | 0.21 | 0.21 | 0.18 | 0.0 | -14.3 |
Sf | 3244 | 0.20 | 0.21 | 0.19 | 5.0 | -5.0 | ||
Sf | 3245 | 0.19 | 0.21 | 0.19 | 10.5 | 0.0 | ||
Sf | 3246 | 0.21 | 0.20 | 0.21 | -4.8 | 0.0 | ||
MEAN | 0.20 | 0.21 | 0.19 | 2.7 | -4.8 | |||
Standard-deviation | 0.01 | 0.00 | 0.01 | 6.6 | 6.7 | |||
3 | 40% | Sf | 3248 | 0.21 | 0.21 | 0.21 | 0.0 | 0.0 |
Sf | 3249 | 0.20 | 0.21 | 0.19 | 5.0 | -5.0 | ||
Sf | 3250 | 0.21 | 0.21 | 0.19 | 0.0 | -9.5 | ||
Sf | 3251 | 0.21 | 0.21 | 0.19 | 0.0 | -9.5 | ||
MEAN | 0.21 | 0.21 | 0.20 | 1.3 | -6.0 | |||
Standard-deviation | 0.00 | 0.00 | 0.01 | 2.5 | 4.5 | |||
4 | 60% | Sf | 3253 | 0.21 | 0.20 | 0.21 | -4.8 | 0.0 |
Sf | 3254 | 0.21 | 0.20 | 0.19 | -4.8 | -9.5 | ||
Sf | 3255 | 0.21 | 0.20 | 0.21 | -4.8 | 0.0 | ||
Sf | 3256 | 0.21 | 0.20 | 0.19 | -4.8 | -9.5 | ||
MEAN | 0.21 | 0.20 | 0.20 | -4.8 | -4.8 | |||
Standard-deviation | 0.00 | 0.00 | 0.01 | 0.0 | 5.5 |
Table 7. Individual ear biopsy and lymph node weights
Groups | Test item | Animals No. | ear weight Day 6 (mg) | % of ear weight increased/group1 | lymph nodes (mg) | |
1 | PG | Sf | 3218 | 29.4 |
| 4.2 |
Sf | 3219 | 25.8 |
| 5.1 | ||
Sf | 3220 | 26.8 |
| 4.4 | ||
Sf | 3221 | 25.2 |
| 3.3 | ||
MEAN | 26.8 |
| 4.3 | |||
Standard-deviation | 1.9 |
| 0.7 | |||
2 | 20% | Sf | 3243 | 26.0 | 1.8 | 3.3 |
Sf | 3244 | 27.5 | 4.9 | |||
Sf | 3245 | 26.9 | 4.1 | |||
Sf | 3246 | 28.7 | 3.8 | |||
MEAN | 27.3 | 4.0 | ||||
Standard-deviation | 1.1 | 0.7 | ||||
3 | 40% | Sf | 3248 | 25.6 | 0.4 | 5.0 |
Sf | 3249 | 26.5 | 5.4 | |||
Sf | 3250 | 28.7 | 4.5 | |||
Sf | 3251 | 26.8 | 4.5 | |||
MEAN | 26.9 | 4.9 | ||||
Standard-deviation | 1.3 | 0.4 | ||||
4 | 60% | Sf | 3253 | 27.0 | 4.2 | 5.3 |
Sf | 3254 | 28.0 | 5.0 | |||
Sf | 3255 | 28.2 | 6.5 | |||
Sf | 3256 | 28.5 | 5.8 | |||
MEAN | 27.9 | 5.7 | ||||
Standard-deviation | 0.7 | 0.7 |
Table 8. Summary of results- skin irritation.
Groups | Test item | Ear thickness increase D6/D1 (%) | Biopsy ear weight Increase (%) | Excessive irritation # |
1 | PG | -1.2 | n.a | No |
2 | 20% | -4.8 | 1.8 | No |
3 | 40% | -6.0 | 0.4 | No |
4 | 60% | -4.8 | 4.2 | No |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, the substance is not classified for skin sensitization according to CLP Regulation no. 1272/2008.
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