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EC number: 944-675-8 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 November - 20 December 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was conducted in accordance with international guidelines and in accordance with GLP. All guideline validity criteria were met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- 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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Reaction products of 3-methyl-5-[(1S,4aS,8aS)-5,5,8a-trimethyl-2-methylenedecahydro-1-naphthalenyl]-1-penten-3-ol, cyclized
- Molecular formula:
- Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)
- IUPAC Name:
- Reaction products of 3-methyl-5-[(1S,4aS,8aS)-5,5,8a-trimethyl-2-methylenedecahydro-1-naphthalenyl]-1-penten-3-ol, cyclized
- Test material form:
- liquid: viscous
- Details on test material:
- Appearance: Off white paste
1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Recognised supplier
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: Not reported
- Age at study initiation: ca. 10 weeks
- Weight at study initiation: all within ± 20 % of the mean sex value
- Housing: Makrolon cage (MIII type; height 18 cm) containing sterilised sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany). Paper (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom) and shelters (disposable paper corner home, MCORN 404, Datesand Ltd, USA) were supplied as cage-enrichment. The acclimatization period was at least 5 days before the start of treatment under laboratory conditions. On Day 6, the animals were group housed in Makrolon MII type cages with a sheet of paper instead of sawdust and cage enrichment.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
- Indication of any skin lesions: Not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24 ºC
- Humidity (%): 40 - 70 %
- Air changes (per hr): min. 10
- Photoperiod (hrs dark / hrs light): 12 / 12
- IN-LIFE DATES: Not reported
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 2, 5, 10 % w/w
- No. of animals per dose:
- 5 per study group
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility:solubilised in acetone:olive oil (4:1 v/v)
- Irritation: Yes
- Systemic toxicity: Yes
- Ear thickness measurements: Yes
- Erythema scores: Yes
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Mouse LLNA
- Criteria used to consider a positive response: Stimulation Index (SI) - an SI result greater than or equal to 3 indicates that the test item is a skin sensitiser.
TREATMENT PREPARATION AND ADMINISTRATION:
Test item and positive control preparation
The test item and positive control item preparations (w/w) were prepared within 4 hours prior to each dosing. Test item preparations were stirred for 30 minutes during preparation. No adjustment was made for specific gravity of the vehicle. Homogeneity was assessed by visual inspection of the solutions. Correction of the purity/composition of the test item is not applicable, since the test method requires a logical concentration range rather than specific dose levels to be dosed.
Induction
The dorsal surface of both ears was topically treated (25 μL/ear) with the test item, at approximately the same time on each day. The concentrations were stirred with a magnetic stirrer immediately prior to dosing. The vehicle and positive control animals were treated in the same way as the experimental animals, except that the vehicle and/or positive control item was administered instead of the test item. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- DPM values are presented for each animal and for each dose group. A Stimulation Index (SI) is calculated for each group using the individual SI values. The individual SI is the ratio of the DPM/animal compared to the DPM/vehicle control group mean.
Results and discussion
- Positive control results:
- The positive control group added to the study showed that the vehicle is suitable for eliciting a SI>3 in this batch of animals and with the procedures used for this study.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- 2 % w/w
- Key result
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- 5 % w/w
- Key result
- Parameter:
- SI
- Value:
- 2.2
- Test group / Remarks:
- 10 % w/w
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
N/A
DETAILS ON STIMULATION INDEX CALCULATION:
Mean DPM/animal values for the experimental groups treated with test item concentrations 2, 5 and 10% were 368, 471 and 966 DPM, respectively. The mean DPM/animal value for the vehicle control group was 443 DPM and a mean DPM/animal value of 1840 DPM was obtained from the positive control group. The SI values calculated for the test item concentrations 2, 5 and 10% were 0.8, 1.1 and 2.2, respectively.
EC3 CALCULATION
> 10 % w/w
CLINICAL OBSERVATIONS:
None (none obesrved in pre-screen test at 10 % w/w test group).
BODY WEIGHTS:
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
Any other information on results incl. tables
Table 2: Body weights and skin reaction
group |
TS1 (%) |
animal |
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
||||||||
bw (g)2 |
erythema3 |
erythema |
erythema |
erythema |
erythema |
erythema |
bw (g) |
|||||||||
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
|||||
1 |
0 |
1 |
20.0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
19.3 |
|
|
2 |
19.8 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
20.1 |
|
|
3 |
19.3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
20.5 |
|
|
4 |
19.6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
20.7 |
|
|
5 |
20.0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
21.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2 |
2 |
6 |
20.6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
20.7 |
|
|
7 |
21.1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
22.0 |
|
|
8 |
20.5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
21.6 |
|
|
9 |
23.2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
23.2 |
|
|
10 |
22.5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
21.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3 |
5 |
11 |
20.8 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
20.0 |
|
|
12 |
21.4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
21.9 |
|
|
13 |
20.3 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
20.1 |
|
|
14 |
20.6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
21.4 |
|
|
15 |
19.4 |
1 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
19.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4 |
10 |
16 |
22.4 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
20.8 |
|
|
17 |
21.3 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
21.2 |
|
|
18 |
22.6 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
22.1 |
|
|
19 |
22.6 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
20.6 |
|
|
20 |
21.1 |
0 |
1 |
1 |
1 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
1 |
20.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5 |
HCA |
21 |
19.5 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1s |
1 |
1s |
1s |
19.3 |
|
25 |
22 |
24.0 |
1 |
1 |
1 |
2 |
2 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
22.1 |
|
|
23 |
21.7 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
20.9 |
|
|
24 |
20.3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1s |
1s |
1s |
20.8 |
|
|
25 |
19.4 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1s |
1 |
1s |
19.8 |
s.Scaliness
1 TS = test item (% w/w).
2 Body weight (grams).
3 Grading erythema and eschar formation(Left = dorsal surface of left ear; right = dorsal surface of right ear):
0 = No erythema
1 = Very slight erythema (barely perceptible)
2 = Well-defined erythema
Table 3: Relative size lymph nodes, radioactivity counts and stimulation index
group |
TS1 (%) |
animal |
Size nodes2 |
DPM3/ animal |
mean DPM ± SEM4 |
mean SI ± SEM |
|||||
left |
right |
||||||||||
1 |
0 |
1 |
n |
n |
414 |
443 |
± |
62 |
1.0 |
± |
0.2 |
|
|
2 |
n |
n |
462 |
||||||
|
|
3 |
n |
n |
236 |
||||||
|
|
4 |
n |
n |
618 |
||||||
|
|
5 |
n |
n |
483 |
||||||
|
|
|
|
|
|
|
|
|
|
|
|
2 |
2 |
6 |
n |
n |
291 |
368 |
± |
23 |
0.8 |
± |
0.1 |
|
|
7 |
n |
n |
431 |
||||||
|
|
8 |
n |
n |
364 |
||||||
|
|
9 |
+ |
+ |
394 |
||||||
|
|
10 |
n |
n |
359 |
||||||
|
|
|
|
|
|
|
|
|
|
|
|
3 |
5 |
11 |
n |
n |
309 |
471 |
± |
78 |
1.1 |
± |
0.2 |
|
|
12 |
n |
n |
564 |
||||||
|
|
13 |
n |
n |
264 |
||||||
|
|
14 |
n |
n |
560 |
||||||
|
|
15 |
n |
n |
660 |
||||||
|
|
|
|
|
|
|
|
|
|
|
|
4 |
10 |
16 |
+ |
+ |
523 |
966 |
± |
157 |
2.2 |
± |
0.5 |
|
|
17 |
+ |
+ |
919 |
||||||
|
|
18 |
+ |
+ |
758 |
||||||
|
|
19 |
+ |
+ |
1260 |
||||||
|
|
20 |
+ |
+ |
1369 |
||||||
|
|
|
|
|
|
|
|
|
|
|
|
5 |
HCA |
21 |
+ |
+ |
426 |
1840 |
± |
546 |
4.2 |
± |
1.4 |
|
25 |
22 |
+ |
+ |
711 |
||||||
|
|
23 |
+ |
+ |
3217 |
||||||
|
|
24 |
+ |
+ |
2193 |
||||||
|
|
25 |
+ |
+ |
2653 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was not considered to be a skin sensitiser.
- Executive summary:
The skin sensitising potential of the test item was established in accordance with OECD guideline 429 using the mouse local lymph node assay method.
Test item concentrations selected for the main study were based on the results of a pre-screen test.
In the main study, three experimental groups of five female CBA/J mice were treated with test item concentrations of 2, 5 or 10% w/w on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with the vehicle alone (Acetone/Olive oil (4:1 v/v)) and another group of five animals received a positive control item (HCA).
Three days after the last exposure, all animals were injected with3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised and pooled for each animal. After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of disintegrations per minute (DPM) and a stimulation index (SI) was subsequently calculated for each group.
The very slight erythema of the ears as shown by several animals treated at 5% between Days 1 and 3 and all animals treated at 10% between Days 1 and 6 was considered not to have a toxicologically significant effect on the activity of the nodes.
The very slight to well-defined erythema and/or scaliness as shown by all animals of the positive control group between Days 1 and 6 was considered not to have a toxicologically significant effect on the activity of the nodes.
Variations in ear thickness during the observation period were less than 25% from Day 1 pre-dose values. Except for the ear thickness of ear of one positive control animal on Day 2 only which was enlarged by 27%. This incidental finding was considered not to have a toxicologically significant effect on the activity of the nodes.
The majority of auricular lymph nodes were considered normal in size, except for the nodes in one animal treated at 2%, all animals treated at 10% and all positive control animals, which were considered enlarged. No macroscopic abnormalities of the surrounding area were noted for any of the animals.
Mean DPM/animal values for the experimental groups treated with test item concentrations 2, 5 and 10% were 368, 471 and 966 DPM, respectively. The mean DPM/animal value for the vehicle control group was 443 DPM and a mean DPM/animal value of 1840 DPM was obtained from the positive control group. The SI values calculated for the test item concentrations 2, 5 and 10% were 0.8, 1.1 and 2.2, respectively.
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