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EC number: 814-113-5 | CAS number: 253454-23-8
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 April 2016 - 9 February 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The test was conducted before the REACH regulation came into force requesting in vitro testing first.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- Version / remarks:
- 22 July 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
Test material
- Reference substance name:
- rel-1-[(1R,6S)-2,2,6-trimethylcyclohexyl]hexan-3-ol
- EC Number:
- 814-113-5
- Cas Number:
- 253454-23-8
- Molecular formula:
- C15H30O
- IUPAC Name:
- rel-1-[(1R,6S)-2,2,6-trimethylcyclohexyl]hexan-3-ol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Hysandol called Timberol in the test report may be a multi of the cis and trans-isomer, while Hysandol is a mono-trans isomer. The cis isomer is expected to have the same results for this endpoint because it is stereo isomer.
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/N
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Central Lab. Animal Inc., Republic of Korea
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: 9 weeks old
- Weight at study initiation: 16.7-21.2 g (set 1) and 16.5-20.8 g (set 2)
- Housing: 2- 3 animals per cage, housed in polysulfone cages (200W x 320D x 140H (mm))
- Diet (e.g. ad libitum): Pelleted rodent chow (Teklad Certified Irradiated Global 18% Protein Rodent Diet 2918C), ad libitum
- Water (e.g. ad libitum): Public tap water in Cheongju-si (filtered and irradiated by ultraviolet light), ad libitum
- Acclimation period: 4 days (dose range finding study and main study/set 2) and 11 days (main study/set 1)
- Indication of any skin lesions: General health examinations were conducted by a staff veterinarian on the last day of the quarantine-acclimation period: no clinical abnormalities or abnormal body weight gains were observed.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.3–22.8°C (set 1) and 21.1–22.3°C (set 2)
- Humidity (%): 45.7–59.1% (set 1) and 49.5–55.4% (set 2)
- Air changes (per hr): 10–15 (filtered air)
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 10 May 2016 To: 15 May 2016 (set 1) and From: 10 November 2016 To: 15 November 2016 (set 2)
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 25, 50 and 100% (set 1); 0, 1, 5 and 10% (set 2)
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: the test substance was dissolved in the vehicle in a preliminary solubility test.
- In the dose range finding study, clinical signs, body weights, ear thickness, ear weights and erythema score by the toxicity of the test substance were evaluated.
MAIN STUDY: the main study was conducted in two sets, with lower treatment doses used in the second set.
TREATMENT PREPARATION AND ADMINISTRATION: A volume of 25 μL was applied to the dorsum of both ears of all animals daily for three consecutive days. The dose level of the positive substance was selected at 25%. Negative control animals were dosed with the vehicle, acetone/olive oil solution.
OBSERVATIONS:
- Clinical signs: All animals were observed for mortality, general condition and clinical signs for 6 days.
- Body weights: Body weights were recorded prior to dosing (day 1) and on the day of necropsy (day 6).
- Erythema: Both ears of each mouse were observed for erythema and scored for 6 days.
- Ear thickness: Ear thickness measurement was taken using a thickness gauge (543-681B, Mitutoyo Co., Japan) on day 1 (pre-dose), day 3 (approximately 48 hours after the first dose) and day 6 (the day of necropsy).
On day 5, a volume of 0.5 mL (5 mg/mouse) of BrdU (10 mg/mL) solution was injected (1mL, 26G) interperitoneally. 24 hours after BrdU injection, necorpsy was conducted on all animals. The draining auricular lymph nodes from each mouse ear were excised and processed separately in phosphate buffered saline for each animal.
Evaluation criteria:
SI Result
SI < 1.6 Negative
SI ≥ 1.6 Positive
Determination of cellular proliferation: BrdU was measured by ELISA: 100 μL of the LNC suspension was added to the wells of a flat-bottom microplate in triplicate. After fixation and denaturation of the LNC suspension, anti-BrdU antibody was added to each well and allowed to react. Subsequently, anti-BrdU antibody was removed by washing and the substrate solution was then added and allowed to produce chromogen. Absorbance at 370 nm with a reference wavelength of 492 nm was measured.
BrdU labelling index = (ABSem - ABSblank,em) - (ABSref-ABSblank,ref)
with ABS = Absorption; em = emission wavelength; ref= reference substance
SI= mean of BrdU labelling index in the test substance / mean of BrdU labelling index in the negative control
Acceptability criterium: positive control should have a SI ≥ 1.6. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Statistical analysis was conducted using a statistical program (version 9.3, SAS Institute Inc., U.S.A.) for the data including body weight, erythema score, ear thickness, ear weight and stimulation index.
Homogeneity of variance for body weights, ear thickness, ear weight and stimulation index: Bartlett’s test (α=0.05); homogeneous data; Dunnett’s ttest (α=0.05 and 0.01, one-tailed): multiple comparisons between the negative control group and each of the test substance groups. Since not significant, Kruskal-Wallis test was employed on heterogeneous data and Steel’s test was applied for multiple comparisons (α=0.05 and 0.01, onetailed) between the negative control group and each of the test substance groups or positive control group.
Erythema score: Kruskal-Wallis test on heterogenous data; Steel’s test for multiple comparisons (α=0.05 and 0.01, one-tailed) between the negative control group and each of the test substance groups or the positive control group.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- other: EC1.6 value (%)
- Value:
- 12.73
- Parameter:
- SI
- Value:
- 1.33
- Test group / Remarks:
- 1%
- Remarks on result:
- other: 1% test group
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 5%
- Remarks on result:
- other: 5% test group
- Parameter:
- SI
- Value:
- 1.27
- Test group / Remarks:
- 10%
- Remarks on result:
- other: 10% test group
- Parameter:
- SI
- Value:
- 1.91
- Test group / Remarks:
- 25%
- Remarks on result:
- other: 25% test group
- Parameter:
- SI
- Value:
- 3.53
- Test group / Remarks:
- 50%
- Remarks on result:
- other: 50% test group
- Parameter:
- SI
- Value:
- 2.35
- Test group / Remarks:
- 100%
- Remarks on result:
- other: 100% test group
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION
SI= mean of BrdU labelling index in the test substance/mean of BrdU labelling index in the negative control
EC1.6 CALCULATION:
EC1.6=c+[(1.6-d)/(b-d)] x (a-c)
a = The dose concentration with higher SI
b = The higher SI value
c = The dose concentration with lower SI
d = The lower SI value
CLINICAL OBSERVATIONS: There were no abnormal clinical signs or deaths in any dosing group during the observation period in both sets.
BODY WEIGHTS (mean)
- Set 1:
Negative control: 19.1–19.5 g (prior to dosing until day 6 after dosing.)
Positive control: 18.5–19.6 g. There were no significant differences when compared to the negative control group.
The test substance groups at 25, 50 and 100%: 19.3–18.9, 18.9–19.0 and 18.9–19.0 g, respectively. There were no significant differences when compared to the negative control group.
- Set 2:
Negative control: 18.7–18.9 g (prior to dosing until day 6 after dosing).
Positive control: 18.6–19.2 g. There were no significant differences when compared to the negative control group.
The test substance groups at 1, 5 and 10%: 18.6–18.5, 19.4–19.6 and 18.7–19.1 g, respectively. There were no significant differences when compared to the negative control group.
ERYTHEMA SCORE:
- Set 1:
Negative control: 0.0–0.0
Positive control: 0.0–0.7. There was a significant increase when compared to the negative control group (p<0.01: day 4, 5 and 6).
Test substance groups at 25, 50 and 100%: 0.0–0.3, 0.0–0.6 and 0.0–0.5, respectively. There was a significant increase when compared to the negative control group (p<0.05: Days 4, 5 and 6: 50 and 100%).
- Set 2:
Negative control: 0.0–0.0
Positive control: 0.0–1.8. There was a significant increase when compared to the negative control group (p<0.01: day 2, 3, 4, 5 and 6).
Test substance groups at 1, 5 and 10%: 0.0–0.0, 0.0–0.1 and 0.0–1.0, respectively. There was a significant increase when compared to the negative control group (p<0.01: days 4, 5 and 6: 10%).
EAR THICKNESS:
- Set 1:
Negative control: 0.20–0.20 mm
Positive control: 0.19–0.21 mm. There was a significant increase when compared to the negative control group (p<0.01: day 3, p<0.05: day 6).
Test substance group at 25, 50 and 100%: 0.19–0.20, 0.20–0.21 and 0.19–0.21 mm, respectively. There was a significant increase when compared to the negative control group (p<0.01: Day 3: 25, 50 and 100%, Day 6: 50 and 100%).
- Set 2:
Negative control: 0.19–0.19 mm
Positive control: 0.19–0.21 mm. There was a significant increase when compared to the negative control group (p<0.01: day 6).
Test substance group at 1, 5 and 10%: 0.19–0.19, 0.19–0.19 and 0.19–0.20 mm, respectively. There was a significant increase when compared to the negative control group (p<0.05: day 6: 10%, p<0.01: day 3: 10%).
EAR WEIGHTS (mean):
- Set 1:
Negative control: 12.9 mg.
Positive control: 14.9 mg. There was a significant increase when compared to the negative control group (p<0.01).
Test substance groups at 25, 50 and 100%: 15.3, 16.0 and 18.9 mg, respectively. There was a significant increase when compared to the negative control group (p<0.01: 25, 50 and 100%).
STIMULATION INDEX/EC1.6:
- Set 1:
Negative control: 1.00.
Positive control: 2.41. There was a significant increase when compared to the negative control group.
Test substance groups at 25, 50 and 100%: 1.91, 3.53 and 2.35, respectively. There was a significant increase when compared to the negative control group (p<0.05: 25, 50 and 100%).
- Set 2:
Negative control group: 1.00.
Positive control: 3.16. There was a significant increase when compared to the negative control group (p<0.01).
Test substance groups at 1, 5 and 10%: 1.33, 1.20 and 1.27, respectively. There were no significant differences when compared to the negative control group.
Three concentration showed SI of >1.6, and EC1.6 was calculated to be 12.73%
Any other information on results incl. tables
Estimation of the Proliferative Response of Lymph Node Cells
Treatment Group |
Concentration |
Stimulation Index |
Result |
Test Item |
25%v/vin |
1.91 |
Positive |
50%v/vin |
3.53 |
Positive |
|
100% |
2.35 |
Positive |
|
Positive |
25%v/vin |
2.41 |
Positive |
Clinical Observations, Bodyweight and Mortality Data – Preliminary Screening Test
Concentration |
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 |
|||||
0 |
2101 |
19.0 |
21.0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 | 2102 | 16.9 | 19.1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5 | 2201 | 16.5 | 20.4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5 | 2202 | 16.4 | 19.3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
10 | 2301 | 16.8 | 20.0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
10 | 2302 | 17.5 | 19.5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
25 | 2401 | 16.4 | 19.8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
25 | 2402 | 16.1 | 19.5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
50 | 2501 | 16.8 | 19.8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
50 | 2502 | 15.7 | 19.7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
100 | 2601 | 19.1 | 18.6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
100 | 2601 | 19.2 | 20.4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
0= No abnormalities detected
Local Skin Irritation
Concentration |
Animal Number |
Local Skin Irritation |
|||||||||||
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
||||||||
25% | mean | 0 | 0 | 0.2 | 0.3 | 0.3 | 0.3 | ||||||
50% | mean | 0 | 0 | 0.2 | 0.6 | 0.6 | 0.6 | ||||||
100% | mean | 0 | 0.2 | 0.3 | 0.5 | 0.5 | 0.5 | ||||||
Positive control (SET 1) | mean | 0 | 0 | 0.1 | 0.7 | 0.7 | 0.7 | ||||||
Negative control (SET 1) | mean | 0 | 0 | 0 | 0 | 0 | 0 | ||||||
1% | mean | 0 | 0 | 0 | 0 | 0 | 0 | ||||||
5% | mean | 0 | 0 | 0.1 | 0.1 | 0.1 | 0.1 | ||||||
10% | mean | 0 | 0.3 | 0.4 | 0.8 | 0.9 | 1.0 | ||||||
Positive control (SET 2) | mean | 0 | 0.6 | 1.1 | 1.7 | 1.7 | 1.8 |
|
|||||
Negative control (SET 2) |
mean |
0 |
0 |
0 |
|
0 |
0 |
0 |
|
|
|
|
|
Measurement of Ear Thicknessand Mean Ear Thickness Changes – SET 1
Concentration: 100% |
Ear Thickness Measurement (mm) |
||||||
Day 1 |
Day 3 |
Day 6 |
|||||
pre‑dose |
post dose |
||||||
|
|
|
|||||
overall mean (mm) |
0.19 |
0.21 |
0.21 |
||||
overall mean |
na |
10.5 |
10.5 |
Measurement of Ear Thicknessand Mean Ear Thickness Changes – SET 2
Concentration: 25% |
Ear Thickness Measurement (mm) |
||||||
Day 1 |
Day 3 |
Day 6 |
|||||
pre‑dose |
post dose |
||||||
|
|
|
|||||
overall mean (mm) |
0.19 |
0.21 |
0.21 |
||||
overall mean |
na |
10.5 |
10.5 |
na= Not applicable
Individual Clinical Observations and Mortality Data
Treatment Group |
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 |
2101 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2102 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2103 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2104 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2105 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Test Item |
2201 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2202 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2203 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2204 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2205 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Test Item |
2301 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2302 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2303 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2304 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2305 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Test Item |
2401 |
0 |
0 |
0 |
0· |
0 |
0· |
0 |
0 |
0 |
2402 |
0 |
0 |
0 |
0· |
0 |
0· |
0 |
0 |
0 |
|
2403 |
0 |
0 |
0 |
0· |
0 |
0· |
0 |
0 |
0 |
|
2404 |
0 |
0 |
0 |
0· |
0 |
0· |
0 |
0 |
0 |
|
2405 |
0 |
0 |
0 |
0· |
0 |
0· |
0 |
0 |
0 |
|
Positive Control Item 25% v/v in |
2501 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2502 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2503 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2504 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2505 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0= No signs of systemic toxicity
Individual Bodyweights and Bodyweight Changes
Treatment Group |
Animal Number |
Bodyweight (g) |
Bodyweight Change (g) |
|
Day 1 |
Day 6 |
|||
Vehicle |
2101 |
19 |
21 |
2 |
2102 |
16.9 |
19.1 |
2.2 |
|
2103 |
15.4 |
18.4 |
3 |
|
2104 |
16.5 |
18.3 |
1.8 |
|
2105 |
17.4 |
18.3 |
0.9 |
|
Test Item |
2201 |
16.5 |
20.4 |
3.9 |
2202 |
16.4 |
19.3 |
2.9 |
|
2203 |
17.0 |
18.5 |
1.5 |
|
2204 |
16.9 |
18.3 |
1.4 |
|
2205 |
16.5 |
18.3 |
1.8 |
|
Test Item |
2301 |
16.8 |
20.0 |
3.2 |
2302 |
17.5 |
19.5 |
2.0 |
|
2303 |
16.7 |
18.8 |
2.1 |
|
2304 |
16.6 |
18.4 |
1.8 |
|
2305 |
15.1 |
18.2 |
3.1 |
|
Test Item |
2401 |
16.4 |
19.8 |
3.4 |
2402 |
16.1 |
19.5 |
3.4 |
|
2403 |
16.8 |
19.1 |
2.3 |
|
2404 |
15.5 |
18.7 |
3.2 |
|
2405 |
14.9 |
17.8 |
2.9 |
|
Positive Control Item 25% v/v in |
2501 |
16.8 |
19.8 |
3.0 |
2502 |
15.7 |
19.7 |
4.0 |
|
2503 |
16.7 |
19.0 |
2.3 |
|
2504 |
16.5 |
18.6 |
2.1 |
|
2505 |
16.2 |
17.6 |
1.4 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin sensitizing Category 1B
- Remarks:
- In accordance with EU CLP (EC No. 1272/2008 and its amendments).
- Conclusions:
- The substance produced a SI ≥ 1.6 and an EC1.6 value of 12.73% was calculated. Based on these results, the substance is considered to be a skin sensitiser 1B.
- Executive summary:
In a Local Lymph Node Assay (BrdU-ELISA), the skin sensitisation potential of the substance was tested according to OECD TG 442B test guideline and GLP principles. Per concentration, 5 female mice were used. Skin sensitization potential was evaluated by ear thickness measurements. Cellular proliferations and SI were determined. In the first set, at 25, 50 and 100%, SI values were 1.91, 3.53 and 2.35, respectively. In the second set, at 1, 5 and 10%, SI values were 1.33, 1.20 and 1.27, respectively. Negative and positive controls were included and all acceptability criteria were met (SI values positive controls: 2.41 and 3.16). These results show that the substance could elicit a SI ≥ 1.6. An EC1.6 value of 12.73% was calculated. Based on the results, the substance is considered a skin sensitiser 1B.
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