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EC number: 211-889-1 | CAS number: 705-86-2
- Life Cycle description
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- Endpoint summary
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- Particle size distribution (Granulometry)
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
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- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Decan-5-olide
- EC Number:
- 211-889-1
- EC Name:
- Decan-5-olide
- Cas Number:
- 705-86-2
- Molecular formula:
- C10H18O2
- IUPAC Name:
- 6-pentyloxan-2-one
- Test material form:
- liquid
- Details on test material:
- Name : Decan-5-olide
Chemical Name (IUPAC) : Decan-5-olide
Molecular Formula : C10-H18-O2
Molecular Weight : 170.25
Origin : Organic
Physical state : Colourless liquid
Purity as per Certificate of Analysis : 97.2 %
Batch No. : P586
InChI: InChI=1S/C10H18O2/c1-2-3-4-6-9-7-5-8-10(11)12-9/h9H,2-8H2,1H3
Smiles : CCCCCC1CCCC(=O)O1
Constituent 1
- Specific details on test material used for the study:
- Name : Decan-5-olide
Chemical Name (IUPAC) : Decan-5-olide
Molecular Formula : C10-H18-O2
Molecular Weight : 170.25
Origin : Organic
Physical state : Colourless liquid
Purity as per Certificate of Analysis : 97.2 %
Batch No. : P586
InChI: InChI=1S/C10H18O2/c1-2-3-4-6-9-7-5-8-10(11)12-9/h9H,2-8H2,1H3
Smiles : CCCCCC1CCCC(=O)O1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo Kreuzelweg 53, 5961 NM Horst, Nederland
- Females (if applicable) nulliparous and non-pregnant: yes, Animals used were nulliparous and non-pregnant
- Microbiological status of animals, when known: Not specified
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 17.0 to 20.5 gm
- Housing: Animals were housed individually (to avoid licking of test item by cage mates) in solid floor standard polysulfone cages (Size: Approximately L 360 x B 205 x H 140 mm), with stainless steel top grill having facilities for providing pelleted food and drinking water in polycarbonate bottle with stainless steel sipper tubes. Steam sterilized corn cob was used as bedding and changed along with the cage once a week
- Diet (e.g. ad libitum): Altromin Rat/Mice Maintenance diets manufactured by Altromin Spezialfutter GmbH & Co. KG, Im Seelenkamp 20, 32791 Lage, Germany, was provided ad libitum
- Water (e.g. ad libitum): Deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier (manufactured by Eureka Forbes Limited, Mumbai - 400 001, India)
- Acclimation period: The animals were acclimatized for 6 days before start of the treatment
- Indication of any skin lesions: After physical examination for good health and the suitability for the study animals were used. No indication of any skin lesions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 24°C
- Humidity (%): 65 to 67 %
- Air changes (per hr): 13.5 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours darkness
- IN-LIFE DATES: From: 18 January 2022 To: 24 February 2022
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Concentration:
- In the irritation screen, the vehicle MEK, concentrations of 10, 25, 50 and 75% v/v in MEK and 100% (undiluted) test item.
In main study (dermal sensitization), the vehicle MEK, concentrations of 25, 50% v/v in MEK and 100% (undiluted) test item. - No. of animals per dose:
- In Iriritation screen - One female mice / dose
In main study - Four female mice / dose - Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: The miscibility / solubility of the test item was tested using AOO, DMF, MEK, PG, MEK and 1% L92 at the following concentrations: 90, 75, 60, 50, 40, 25 and 10 % w/v. The test item is a Colourless liquid. Based on the maximum miscible concentration, MEK was selected as the vehicle. The solubility results were captured in table and attached in any other information on materials and method incl. tables.
- Irritation: In the irritation screen, the vehicle MEK, concentrations of 10, 25, 50 and 75% v/v in MEK and 100% (undiluted) test item were evaluated for irritation potential (1 mouse / group) at each dose level for 3 consecutive days, as measured by erythema of the ears. There were no clinical signs, no erythema at the site of application, no significant increase in the ear thickness and ear punch weights and no effect on body weight. Results from this screening study were used to determine the dosing concentrations of test item for the main LLNA study
- Systemic toxicity: No effects observed.
- Ear thickness measurements: Ear thickness was measured using Digimatic micrometer (Mitutoyo, Japan) prior to dosing on Days 1 and 3 and on day 6. Additionally, on Day 6, ear thickness was determined by ear punch weight determination, after animals were euthanized.
- Erythema scores: Erythema scores, ear thickness and body weight data following the test item applications were compared to the response of the animals treated with vehicle alone.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
Animals were randomly distributed to different groups by body weight stratification method. The mice procured for the study were weighed and grouped into body weight ranges. These body weight stratified animals were distributed to all the study groups. Mice with extreme body weights were removed from the study
- Name of test method: Skin Sensitization: Local Lymph Node Assay
- Criteria used to consider a positive response: If the test item produces a Stimulation Index (SI) < 3, it is considered “Negative” for sensitization, and therefore an EC3 is not determined. Any test material that produces a SI >3 in the LLNA is normally considered “positive” for dermal sensitization potential (Kimber et al., 1994). While a SI >3 was originally developed empirically, a robust statistical evaluation indicated that it is an acceptable practical value for hazard identification (Basketter et al., 1999). While a test material that produces a SI of >3 in the LLNA should be considered “positive” for contact sensitization (Kimber et al., 1994).
TREATMENT PREPARATION AND ADMINISTRATION:
Dose Preparation: Concentrations tested for the irritancy screen were selected based upon solubility in an appropriate LLNA vehicle. The toxicity data regarding the irritation potential was also taken into consideration. The required quantity of the test item was mixed with MEK to get concentration of 25 and 50% v/v The dose formulations were prepared daily just prior to dosing.
Irritation Screen: Concentrations tested for the irritancy screen were selected based upon miscibility in an appropriate LLNA vehicle. The toxicity data regarding the irritation potential was also taken into consideration. Since a concentration of 90% was the maximum miscible concentration in MEK, the highest possible dose concentration of 100% undiluted test item was selected as highest dose concentration for testing.
In the irritation screen, the vehicle MEK, concentrations of 10, 25, 50 and 75% v/v in MEK and 100% (undiluted) test item were evaluated for irritation potential (1 mouse / group), as measured by erythema of the ears. Both ears of six female mice (one mouse/concentration) were topically treated once daily for three consecutive days with one of the concentrations of the test item.
The test item was applied using an adjustable micropipette with disposable tips. All mice received 25 µL of one concentration of the test item, spread over the dorsal surface of each ear in a manner to prevent test item loss (50 µL total / mouse). Similarly, the vehicle was applied to the ears of one animal. Both ears were observed for skin reaction prior to application of the test item (on day 1, 2 and 3), and on day 6. All mice were weighed on Days 1 and 6. Ear thickness was measured using Digimatic micrometer (Mitutoyo, Japan) prior to dosing on Days 1 and 3 and on day 6. Additionally, on Day 6, ear thickness was determined by ear punch weight determination as detailed in paragraph 9.6, after animals were euthanized. Erythema scores, ear thickness and body weight data following the test item applications were compared to the response of the animals treated with vehicle alone. I
Based on the results of this screening study, the dose concentrations of 25, 50% of test item in MEK and 100% (undiluted) test item were selected for the main study, because none of the tested concentrations elicited any irritation reaction, no increased ear thickness and ear punch weights.
Note: Ear thickness and ear punch weight were determined for irritation screen only.
Main Study, Dermal Sensitization: The test item (25 µL/ear) was applied on the dorsum of both ears as described above. Four female mice/group received the vehicle (MEK, the positive control substance (25% v/v α-hexylcinnamaldehyde), and 25, 50% of test item in MEK and 100% (undiluted) test item, once daily for three consecutive days. Both ears were observed for skin reaction prior to application of the test item (on day 1, 2 and 3), and on day 6. All mice were weighed on days 1 and 6.
Preparation of 3H-Methyl Thymidine (3H -TdR): A solution of 3H-TdR (80 µCi/mL) [specific activity 0.9637 mci/mmol; Perkin Elmer, USA] in sterile phosphate buffer saline (PBS) was prepared freshly. The prepared working solution of 3H-TdR was analyzed for radioactivity.
Injection of 3H-Methyl Thymidine (3H -TdR): On day 6, a volume of 250 µL (20 µCi) of 3H-TdR in PBS was administered to each mouse via the lateral tail vein using a 1.0 mL disposable syringe fitted with 26 G x ½ inch needle
Collection of auricular lymph nodes: Approximately five hours post injection of 3H-TdR, animals were euthanized using isoflurane anaesthesia. The auricular lymph nodes (bilateral) were excised and placed in PBS, processed and the radioactivity was counted.
Ear punch weight: The animals were euthanized using isoflurane anesthesia and both ears (left and right) of mice were punched at the apical area using a biopsy punch (Ø 6 mm). For each animal both punches were immediately weighed using an analytical balance.
Processing of auricular lymph nodes : A single cell suspension of the lymph node cells (LNC) from each mouse was prepared by gentle mechanical disaggregation using a tissue homogeniser (Stomacher 80 MicroBiomaster, Seward Ltd, United Kingdom) for 30 seconds at medium speed using PBS (approx. 10 mL).
After all the nodes had been processed, the tubes were centrifuged at 200 x g for 10 minutes at 4°C. The supernatant was poured into a container for radiolabel waste collection. 10 mL of PBS was added to each tube and inverted to resuspend the pellet. The tubes were centrifuged as described above and the supernatant was poured off. After the second wash, the cell pellet was suspended in 3.0 mL of 5% trichloroacetic acid (TCA) and stored overnight at 2-8°C for approximately 19 hours. Clumping of LNC was avoided by ensuring that the pellet was completely resuspended in a small volume of PBS before making up to the final volume. The suspended precipitates were centrifuged at 200 x g for 10 minutes at 4°C and the supernatant was poured off into container for radiolabel waste collection. The pellet from each mouse was reconstituted in 1 mL of 5% TCA and subsequently transferred to a scintillation vial containing 10 mL of a scintillation cocktail (Insta-Gel Plus, PerkinElmer, USA). Two additional 2 mL aliquots of Milli-Q-water were used to rinse the tubes and the rinses were added to the scintillation vial containing 1 mL of the pellet in TCA and cocktail. The samples were mixed using a snapping wrist action.
The radioactivity in each precipitate was measured for 5 minutes using a ß-scintillation counter (Tricarb 4910-TR, Packard Instruments, USA) as disintegrations per minute (dpm) per mouse. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Means and SD were generated for body weight data (absolute and gain) and LLNA response (dpm and SI values). The body weight and dpm data were analysed by one-way analysis of variance. When the differences were indicated by the ANOVA, a comparison of treated vs. control groups was done using a Dunnett’s t-test (p<0.05).
Statistically significant differences (p<0.05), indicated by the aforementioned tests, are designated by the superscripts throughout the report as stated below:
+/- : Significantly higher (+)/lower (-) than the vehicle control group
Results and discussion
- Positive control results:
- Positive controls are used to demonstrate appropriate performance of the assay by responding with adequate and reproducible sensitivity to a sensitising test substance for which the magnitude of the response is well characterised. α-hexylcinnamaldehyde [HCA] (CAS No. 101-86-0) was used as a positive control for contact sensitization. HCA was diluted to 25% v/v in MEK as suggested in test guideline.
The sensitivity of this LLNA assay was demonstrated via the response from the positive control (25% v/v HCA in MEK), which elicited a stimulation index (SI) of 4.16, in comparison with the vehicle-treated mice.
In vivo (LLNA)
Results
- Key result
- Parameter:
- SI
- Value:
- 2.795
- Test group / Remarks:
- G5 100% Concentration of test item(undiluted)
- Remarks on result:
- other: Since, the test item produced a Stimulation Index (SI) < 3, it is considered “Negative” for sensitization
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
: Individual and summary data of Disintegrations Per Minute (DPM) for 3H-Methyl Thymidine incorporation in Auricular Lymph Nodes and Stimulation Index (SI) was mentioned in the section" Any other infomation on results incl. tables"
DETAILS ON STIMULATION INDEX CALCULATION : The SI was calculated for each mouse using the equation mentioned in the section " Any other information on materials and methods incl. tables". The results of calculated SI index values were captured in tabular format and attached in section " Any other infomation on results incl. tables"
EC3 CALCULATION : Since, the test item, produced a Stimulation Index (SI) < 3, it is considered “Negative” for sensitization, and therefore an EC3 was not determined.
CLINICAL OBSERVATIONS: A cage-side examination was conducted twice daily, and the following parameters were evaluated: decreased / increased activity, repetitive behavior, vocalization, incoordination / limping, injury, neuromuscular function (convulsion, fasciculation, tremor, and twitches), altered respiration, blue/pale skin and mucous membranes, severe eye injury (rupture), alterations in fecal consistency, and fecal / urinary quantity. In addition, all animals were observed for morbidity and mortality (twice daily).
The ears were graded for erythema once test item exposure as per scoring system mentioned in the section " Any other information on materials and methods incl. tables".
BODY WEIGHTS: The initial and terminal body weights were recorded.
Any other information on results incl. tables
Resultsand discussion:
Irritation Screening Study
Once daily topical applications of vehicle-MEK, 10, 25, 50 and 75% v/v in MEK and 100% (undiluted)test item were performed to one animal at each dose level for 3 consecutive days. There were no clinical signs, no erythema at the site of application, no significant increase in the ear thickness and ear punch weights and no effect on body weight. Results from this screening study were used to determine the dosing concentrations of test item for the main LLNA study.
Main Study:
The analyzed radioactivity of3H-TdR working solution was 77.38 µCi/mL against the nominal concentration of 80 µCi/mL.
There were no clinical signs, no erythema at the site of application and no significant effect on body weight gains.
The sensitivity of this LLNA assay was demonstrated via the response from the positive control (25% v/v HCA inMEK), which elicited a stimulation index (SI) of 4.16, in comparison with the vehicle-treated mice. The Mean SI values for 25, 50%of test iteminMEK and 100% (undiluted) test item were 2.22, 2.52 and 2.80 respectively.
Irritation Screening Test:
A. Body Weights (g) and Clinical Signs
Mice Nos. |
Dose Concentration |
Day 1 (Pre-dose) |
Day 6 |
Body wt. Gain (g) |
Clinical Signs |
Mh3461 |
Vehicle: MEK |
17.3 |
18.5 |
1.2 |
NAD |
Mh3462 |
10% v/v |
17.2 |
18.3 |
1.1 |
NAD |
Mh3463 |
25% v/v |
17.0 |
18.0 |
1.0 |
NAD |
Mh3464 |
50% v/v |
17.5 |
18.3 |
0.8 |
NAD |
Mh3465 |
75% v/v |
18.3 |
19.1 |
0.8 |
NAD |
Mh3466 |
100 % (undiluted) |
18.5 |
19.2 |
0.7 |
NAD |
NAD: No Abnormality Detected
B.Erythema Scores (for both ears)
Mice Nos. |
Dose Concentration |
Day 1 (Pre-dose) |
Day 2 |
Day 3 |
Day 6 |
Mh3461 |
Vehicle: MEK |
0 |
0 |
0 |
0 |
Mh3462 |
10% v/v |
0 |
0 |
0 |
0 |
Mh3463 |
25% v/v |
0 |
0 |
0 |
0 |
Mh3464 |
50% v/v |
0 |
0 |
0 |
0 |
Mh3465 |
75% v/v |
0 |
0 |
0 |
0 |
Mh3466 |
100 % (undiluted) |
0 |
0 |
0 |
0 |
Erythema scores – 0: No erythema
C.Ear thickness measurement and ear punch weight
Mice Nos. |
Dose Concentration
|
Ear thickness (µm) |
Ear punch weight (g) |
||||||
Day 1 (pre-dose) |
Day 3 |
Day 6 |
Day 6 |
||||||
L.E |
R.E |
L.E |
R.E |
L.E |
R.E |
L.E |
R.E |
||
Mh3461 |
Vehicle: MEK |
252 |
251 |
252 |
252 |
253 |
253 |
0.008 |
0.009 |
Mh3462 |
10% v/v |
253 |
250 |
253 |
250 |
254 |
251 |
0.009 |
0.008 |
Mh3463 |
25% v/v |
251 |
254 |
252 |
254 |
252 |
255 |
0.007 |
0.008 |
Mh3464 |
50% v/v |
256 |
253 |
257 |
253 |
257 |
254 |
0.009 |
0.008 |
Mh3465 |
75% v/v |
261 |
259 |
262 |
260 |
263 |
261 |
0.009 |
0.008 |
Mh3466 |
100 % (undiluted) |
264 |
262 |
264 |
263 |
265 |
263 |
0.010 |
0.009 |
L.E: Left ear; R.E: Right ear
D. Percent change in ear thickness
Mice Nos. |
Dose concentration
|
% Change in ear thickness compared to day 1 |
|||
Day 3 |
Day 6 |
||||
L.E |
R.E |
L.E |
R.E |
||
Mh3461 |
Vehicle: MEK |
0.00 |
0.40 |
0.40 |
0.80 |
Mh3462 |
10% v/v |
0.00 |
0.00 |
0.40 |
0.40 |
Mh3463 |
25% v/v |
0.40 |
0.00 |
0.40 |
0.39 |
Mh3464 |
50% v/v |
0.39 |
0.00 |
0.39 |
0.40 |
Mh3465 |
75% v/v |
0.38 |
0.39 |
0.77 |
0.77 |
Mh3466 |
100 % (undiluted) |
0.00 |
0.38 |
0.38 |
0.38 |
L.E: Left ear; R.E: Right ear
Summary of Body Weight and Body Weight Changes:
Group and Dose Concentration
|
No. of Mice |
|
Body weight (g) |
|||
Day 1 (Initial) |
Day 6 |
Weight change (Day 6 – Initial) |
Clinical signs |
|||
G1 Vehicle:MEK |
4 |
|
|
|
|
|
Mean |
18.975 |
19.900 |
0.925 |
NAD |
||
SD |
1.355 |
1.311 |
0.050 |
|||
|
|
|
|
|
||
G2 25% v/v HCA |
4 |
|
|
|
|
|
Mean |
18.925 |
19.575 |
0.650 |
NAD |
||
SD |
1.044 |
1.034 |
0.058 |
|||
|
|
|
|
|
||
G3 25% v/v test item |
4 |
|
|
|
|
|
Mean |
18.875 |
19.750 |
0.875 |
NAD |
||
SD |
1.040 |
1.008 |
0.050 |
|||
|
|
|
|
|
||
G4 50% v/v test item |
4 |
|
|
|
|
|
Mean |
18.975 |
19.775 |
0.800 |
NAD |
||
SD |
0.768 |
0.793 |
0.082 |
|||
|
|
|
|
|
||
G5 100% (undiluted) |
4 |
|
|
|
|
|
Mean |
18.900 |
19.650 |
0.750 |
NAD |
||
SD |
0.702 |
0.714 |
0.058 |
|||
|
|
|
|
|
Summary of Disintegrations Per Minute (DPM) for3H-Methyl Thymidine Incorporation in Auricular Lymph Nodes and Stimulation Index (SI):
Group and Dose Concentration
|
No. of Mice |
|
DPM / Mouse
|
SI
|
G1 Vehicle:MEK |
4 |
|
|
|
Mean |
590.750 |
1.000 |
||
SD |
196.364 |
0.331 |
||
|
|
|
||
G2 25% v/v HCA |
4 |
|
+ |
|
Mean |
2458.750 |
4.163 |
||
SD |
421.404 |
0.714 |
||
|
|
|
||
G3 25% v/v test item |
4 |
|
+ |
|
Mean |
1311.250 |
2.220 |
||
SD |
366.537 |
0.622 |
||
|
|
|
||
G4 50% v/v test item |
4 |
|
+ |
|
Mean |
1489.000 |
2.520 |
||
SD |
233.522 |
0.396 |
||
|
|
|
||
G5 100% (undiluted) |
4 |
|
+ |
|
Mean |
1652.750 |
2.795 |
||
SD |
206.777 |
0.350 |
||
|
|
|
+: Significantly higher than the vehicle control group, HCA: α – Hexylcinnamaldehyde
Individual Body Weights and Clinical signs:
Group and Dose concentration
|
Mouse No. |
Body weight (g) |
Weight change (g) (Day 6 – Initial) |
Clinical signs |
|||||||
Initial (Pre-Dose) Day 1 |
Day 6 |
||||||||||
G1 Vehicle:MEK |
Mh3191 |
17.2 |
18.2 |
1.00 |
NAD |
||||||
Mh3192 |
20.5 |
21.4 |
0.90 |
NAD |
|||||||
Mh3193 |
19.1 |
20.0 |
0.90 |
NAD |
|||||||
Mh3194 |
19.1 |
20.0 |
0.90 |
NAD |
|||||||
G2 25% v/v HCA |
Mh3195 |
19.2 |
19.8 |
0.60 |
NAD |
||||||
Mh3196 |
20.0 |
20.7 |
0.70 |
NAD |
|||||||
Mh3197 |
17.5 |
18.2 |
0.70 |
NAD |
|||||||
Mh3198 |
19.0 |
19.6 |
0.60 |
NAD |
|||||||
G3 25% v/v test item |
Mh3199 |
19.4 |
20.3 |
0.90 |
NAD |
||||||
Mh3200 |
19.9 |
20.7 |
0.80 |
NAD |
|||||||
Mh3201 |
18.7 |
19.6 |
0.90 |
NAD |
|||||||
Mh3202 |
17.5 |
18.4 |
0.90 |
NAD |
|||||||
G4 50% v/v test item |
Mh3203 |
18.1 |
18.8 |
0.70 |
NAD |
||||||
Mh3204 |
18.6 |
19.5 |
0.90 |
NAD |
|||||||
Mh3205 |
19.4 |
20.2 |
0.80 |
NAD |
|||||||
Mh3206 |
19.8 |
20.6 |
0.80 |
NAD |
|||||||
G5 100% (undiluted) |
Mh3207 |
18.2 |
18.9 |
0.70 |
NAD |
||||||
Mh3208 |
18.4 |
19.2 |
0.80 |
NAD |
|||||||
Mh3209 |
19.4 |
20.1 |
0.70 |
NAD |
|||||||
Mh3210 |
19.6 |
20.4 |
0.80 |
NAD |
NAD: No Abnormality Detected, HCA: α – Hexylcinnamaldehyde
Individual Local Reaction Scores at the Site of Application:
Group and Dose Concentration |
Mouse No. |
Erythema Score in both ears |
|||||||
Day 1 Pre-dose |
Day 2 |
Day 3 |
Day 6 |
||||||
R.E |
L.E |
R.E |
L.E |
R.E |
L.E |
R.E |
L.E |
||
G1 Vehicle:MEK |
Mh3191 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mh3192 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mh3193 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mh3194 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
G2 25% v/v HCA |
Mh3195 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
Mh3196 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
|
Mh3197 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
|
Mh3198 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
|
G3 25% v/v test item |
Mh3199 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mh3200 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mh3201 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mh3202 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
G4 50% v/v test item |
Mh3203 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mh3204 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mh3205 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mh3206 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
G5 100% (undiluted) |
Mh3207 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mh3208 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mh3209 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mh3210 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
L.E: Left ear ; R.E: Right ear;0 : No erythema; 1 :Very slight erythema (barely perceptible)HCA: α – Hexylcinnamaldehyde
Disintegrations Per Minute (DPM) for3H-Methyl Thymidine Incorporation in Auricular Lymph Nodes and Stimulation Index (SI):
Group and Dose concentration |
Mouse No. |
*DPM/Mouse |
SI |
||||
G1 Vehicle:MEK |
Mh3191 |
732 |
1.24 |
||||
Mh3192 |
539 |
0.91 |
|||||
Mh3193 |
335 |
0.57 |
|||||
Mh3194 |
757 |
1.28 |
|||||
G2 25% v/v HCA |
Mh3195 |
2066 |
3.50 |
||||
Mh3196 |
3024 |
5.12 |
|||||
Mh3197 |
2521 |
4.27 |
|||||
Mh3198 |
2224 |
3.76 |
|||||
G3 25% v/v test item |
Mh3199 |
1551 |
2.63 |
||||
Mh3200 |
1283 |
2.17 |
|||||
Mh3201 |
804 |
1.36 |
|||||
Mh3202 |
1607 |
2.72 |
|||||
G4 50% v/v test item |
Mh3203 |
1802 |
3.05 |
||||
Mh3204 |
1447 |
2.45 |
|||||
Mh3205 |
1470 |
2.49 |
|||||
Mh3206 |
1237 |
2.09 |
|||||
G5 100% (undiluted) |
Mh3207 |
1898 |
3.21 |
||||
Mh3208 |
1484 |
2.51 |
|||||
Mh3209 |
1750 |
2.96 |
|||||
Mh3210 |
1479 |
2.50 |
HCA: α – Hexylcinnamaldehyde, *: DPM / Mouse = Measured DPM – Average Background DPM
Applicant's summary and conclusion
- Interpretation of results:
- other: Not-sensitising
- Conclusions:
- A topical application with 25, 50% of test item in MEK and 100% (undiluted) test item elicited a stimulation index (SI) of 2.22, 2.52 and 2.80 respectively. The test item DECAN-5-OLIDE (CAS: 705-86-2) did not demonstrate dermal sensitization potential in the mouse LLNA, as the lymph nodes draining the area of topical application did not elicit a proliferative response greater than the 3X threshold.
- Executive summary:
The test item,DECAN-5-OLIDE (CAS: 705-86-2) was evaluated for the potential to cause contact sensitization by measuring the lymphocyte proliferative response from auricular lymph nodes following topical application to the female CBA/Ca mouse ear.The test item was formulated in Methyl Ethyl Ketone (MEK) following a solubility assessment.
Screening Study: One female CBA/Ca mice/dose received the vehicle MEK and10, 25, 50 and 75% v/v of test item inMEK and 100% (undiluted) test item respectively once daily for three consecutive days. There were no clinical signs, no erythema at the site of application, no significant increase in the ear thickness and ear punch weights and no effect on body weight. Based on the results dose concentrations of25, 50% v/vof test item inMEK and 100% (undiluted) test item was selected for the main study.
Main study: Four female CBA/Ca mice/group received the vehicle (MEK), 25% v/v α-hexylcinnamaldehyde (HCA: positive control inMEK), and 25, 50% of test item inMEK and 100% (undiluted) test item once daily for three consecutive days on days 1 to 3. On day 6, the uptake of 3H-methyl thymidine into the auricular lymph nodes draining the site of test item application was measured approximately five hours post administration. Performance of the study was confirmed via a positive response using 25% v/v α-hexylcinnamaldehyde, a contact sensitizer, which elicited proliferation with a Stimulation Index (SI) value of 4.16, in comparison to vehicle-treated miceThere were no clinical signs, no local skin reactions at the tested concentrations and treatment had no significant effect on body weight gain. The test item at dose concentrations of 25, 50% v/vof test iteminMEK and 100% (undiluted) test item elicited proliferative response with SI of 2.22, 2.52 and 2.80 respectively in comparison with the vehicle-treated mice.
The test item “DECAN-5-OLIDE(CAS: 705-86-2)” did not demonstrate dermal sensitization potential in the mouse LLNA, as the lymph nodes draining the area of topical application did not elicit a proliferative response greater than the 3X threshold.
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