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EC number: 458-680-3 | CAS number: 797751-44-1 WASOX-VMAC2
- 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 "Skin Sensitisation: Local Lymph Node Assay" for the test substance was performed in five groups of 5 female CBA mice (According to OECD Guideline 429).
The test substance is regarded as a not sensitising, since the SIs of all examined test substance concentrations were clearly smaller than 3.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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 adequate data from an in vivo skin sensitisation study are available
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
An in vitro study does not need to be conducted since adequate data from an in vivo skin sensitisation study are available. - Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 12-19, 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- According to OECD Guideline 429, with GLP.
- 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
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelman
- Age at study initiation: 8 weeks
- Weight at study initiation: 16.8 – 20.1 g
- Housing: single caging. Makrolon cages type II
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.8 ºC (average)
- Humidity (%): 48.2% (average)
- Photoperiod (hrs dark / hrs light): only artificial light from 6.00 a.m. to 6.00 p. m. - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- High dose: 100% test substance (as it is).
Mid dose: 50% (v/v) solution of the test substance in acetone:olive oil.
Low dose: 25% (v/v) solution of the test substance in acetone:olive oil. - No. of animals per dose:
- five female mice/dose level.
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: Solubility testing showed that the test substance solves for at least 50% (v/v) in vehicle AOO.
- Irritation: about 24 hours after the last administration of the test substance as it is (100%) little increase in ear thickness was observed.
TREATMENT PREPARATION AND ADMINISTRATION:
Administration was performed epicutaneously to the dorsal surface of both ears, once a day on three consecutive days. The volume administered was 25 µL per ear. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- The positive control result was: 42767 dpm (desintegrations per minute); and a SI (Stimulation Index) of 10.2
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Negative control
- Key result
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- Low dose
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Mid dose
- Key result
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- High dose
- Key result
- Parameter:
- SI
- Value:
- 10.2
- Test group / Remarks:
- Positive control
- Interpretation of results:
- other: Not classified for skin sensitization (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The test substance is regarded as a non sensitiser in the "Skin Sensitisation: Local Lymph Node Assay", since the SIs of all examined test substance concentrations were clearly smaller than 3.
- Executive summary:
The "Skin Sensitisation: Local Lymph Node Assay" for the test substance was performed in five groups of 5 female CBA mice( According to OECD Guideline 429). The doses tested were 100% of test material (as it is); 50% (v/v) and 25 % (v/v). The vehicle used was acetone:oil (4:1, v/v) (AOO). A positive control (25% solution of hexyl cinnamic aldehyde in AOO) and a negative control (AOO) were included on the test. Both control substances were administrated under identical conditions as the test substance. The Administration was performed epicutaneously to the dorsal surface of both ears, once a day on three consecutive days. The volume administrated was 25 µl per ear. 5 days after the first topical administration, each animal received 20 µlCi3HTdR by intravenous administration. Approximately 5 hour after 3HTdR injection all animals were sacrificed and the3HTdR incorporation determinate. The application sites were visually checked for local irritations at least once a day. Body weight was recorded on days 1 and 6 after the administration.
The test substance is regarded as a not sensitising, since the SIs of all examined test substance concentrations were clearly smaller than 3.
Referenceopen allclose all
Body masses
The body mass of each animal was recorded on days 1 and 6.
Individual body masses (b.m.) and body mass gains in g of all animals. Means, standard deviations (SD) and number of animals per group (n).
group K negative control |
|
group A (low dose) |
group B (mid dose) |
group C (high dose) |
group P (positive control) |
||||||||||||||
|
|||||||||||||||||||
animal |
b.m. on Day |
b.m. |
animal |
b.m. on Day |
b.m. |
animal |
b.m. on Day |
b.m. |
animal |
b.m. on Day |
b.m. |
animal |
b.m, on Day |
b.m. |
|||||
No. |
1 |
6 |
gain |
No. |
1 |
6 |
gain |
No. |
1 |
6 |
gain |
No. |
1 |
6 |
oain |
No. |
1 |
6 |
gain |
1 |
18.9 |
21,1 |
2.2 |
31 |
20.1 |
19.6 |
-0.5 |
36 |
18.8 |
20.7 |
1.9 |
41 |
17,7 |
19,2 |
1.5 |
21 |
18.3 |
19.0 |
0.7 |
2 |
18.7 |
20.3 |
1.6 |
32 |
18.1 |
19.4 |
1.3 |
37 |
18.0 |
18.6 |
0.6 |
42 |
20.0 |
20.5 |
0.5 |
22 |
19.9 |
21.3 |
1.4 |
3 |
19.4 |
20.0 |
0.6 |
33 |
19.2 |
20.1 |
0.9 |
38 |
18.8 |
20.4 |
1,6 |
43 |
16.8 |
17.8 |
1.0 |
23 |
17.3 |
18.9 |
1.6 |
4 |
17.8 |
17.8 |
0.0 |
34 |
18.5 |
20.1 |
1.6 |
39 |
18.6 |
19.9 |
1.3 |
44 |
18.6 |
19.7 |
1.1 |
24 |
18.0 |
18.9 |
0.9 |
5 |
19.7 |
21.3 |
1.6 |
35 |
19.5 |
20.2 |
0.7 |
40 |
19,3 |
21.2 |
1.9 |
45 |
19.7 |
21.8 |
2.1 |
25 |
19.3 |
19.8 |
0.5 |
mean |
18.9 |
20.1 |
1.2 |
mean |
19.1 |
19.9 |
0.8 |
mean |
18.7 |
20.2 |
1.5 |
mean |
18.6 |
19.8 |
1,2 |
mean |
18.6 |
19.6 |
1.0 |
SD |
0.7 |
1.4 |
0.9 |
SD |
0.8 |
0.4 |
0.8 |
SD |
0.5 |
1.0 |
0.5 |
SD |
1.3 |
1.5 |
0.6 |
SD |
1.0 |
1.0 |
0.5 |
n |
5 |
5 |
5 |
n |
5 |
5 |
5 |
n |
5 |
5 |
5 |
n |
5 |
5 |
5 |
n |
5 |
5 |
5 |
Body masses and body mass gains of all animals were in the range to be expected from animals of the same strain, sex and age.
Body weight loss was noted in 1/5 animals in group A.
Evidence of sensitisation of each challenge concentration:
Results are presented as test/control ratio (Stimulation index), calculated as dpm test group/dpm negative control group, (dpm - disintegrations per minute, corrected by the subtraction of the background)
dpm results and calculated SIs
|
dpm |
SI |
Group K (negative control) |
4197 |
1 |
Group A (low dose) |
4964 |
1.2 |
Group B (mid dose) |
4383 |
1.0 |
Group C (high dose) |
2736 |
0.7 |
Group P (positive control) |
42767 |
10.2 |
SI: dpm test group/dpm negative contro) group
The stimulation indices of each of the 3 test substance concentrations were below 3: 1.2 at the low concentration, 1.0 at the mid concentration, and 0.7 at the high concentration.
theow concentration, concentration The stimulation index of the positive control was 10.2.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The doses tested were 100% of test material (as it is); 50% (v/v) and 25 % (v/v). The vehicle used was acetone:oil (4:1, v/v) (AOO). A positive control (25% solution of hexyl cinnamic aldehyde in AOO) and a negative control (AOO) were included on the test. Both control substances were administrated under identical conditions as the test substance. The Administration was performed epicutaneously to the dorsal surface of both ears, once a day on three consecutive days. The volume administrated was 25 µl per ear.5 days after the first topical administration, each animal received 20 µlCi3HTdR by intravenous administration. Approximately 5 hour after3HTdR injection all animals were sacrificed and the3HTdR incorporation determinate. The application sites were visually checked for local irritations at least once a day. Body weight was recorded on days 1 and 6 after the administration.
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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