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EC number: 224-580-1 | CAS number: 4418-26-2
- 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
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
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- Endpoint summary
- Stability
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- 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
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- Biotransformation and kinetics
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
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Endpoint summary
Administrative data
Description of key information
Local lymph node assay: not a skin sensitiser
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:
- other:
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 May - 11 Jun 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 23 Jul 2010
- Deviations:
- yes
- Remarks:
- ear thickness measurements in pre-test not performed
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, ländlichen Raum und Verbraucherschutz, Wiesbaden, Germany
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- Dehydroacetic acid
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands, Horst, The Netherlands
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 20.2 ± 0.5
- Housing: Individual in Makrolon Type I with wire mesh top and granulated soft wood bedding
- Diet: pelleted standard diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- propylene glycol
- Concentration:
- 5, 10 and 20% (w/v)
- No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: The highest test item concentration, which can be technically used was a 20 % suspension in propylene glycol.
- Irritation: To determine the highest non-irritant test concentration, a pre-test was performed in two animals. Two mice were treated with concentrations of 2.5, 5, 10, and 20 % on one ear each on three consecutive days. Clinical signs were recorded 24 ± 4 hours after each application. At the tested concentrations the animals did not show any signs of irritation.
- Systemic toxicity: During the pre-test, no systemic toxicity could be observed.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-methyl thymidine incorporation determined by β-scintillation.
- Criteria used to consider a positive response: The proliferative response of lymph node cells is expressed as the number of radioactive disintegrations per minute per lymph node (DPM/node) and as the ratio of 3HTdR incorporated into lymph node cells of test lymph nodes relative to that recorded for control lymph nodes (stimulation index). Before DPM/node values were determined, mean scintillation-background DPM was subtracted from test and control raw data.
A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the stimulation index.
- Second, that the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
25 µl of the test compound was applied to the entire dorsal surface of each ear of each mouse. The application was repeated on days 2 and 3. On day 6 an injection of 250 µl phosphate buffered saline (PBS) containing 19.7 µCi of 3H-methylthymidine (3H-TdR) into the tail vein of each experimental mouse. Five hours later, the draining auricular lymph node of each ear was excised into PBS. A single cell suspension of lymph node cells was prepared from each mouse and pooled per group (8 nodes per group).The draining lymph nodes were rapidly excised and pooled per group (8 nodes per group).Single cell suspensions (in phosphate buffered saline) of pooled lymph node cells were prepared by gentle mechanical disaggregation through stainless steel gauze (200 um mesh size). After washing two times with phosphate buffered saline (approx. 10 ml) the lymph node cells were resuspended in 5 % trichloroacetic acid (approx. 3 ml) and incubated at approximately +4 °C for at least 18 hours for precipitation of macromolecules. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations of the body weights were calculated.
- Positive control results:
- The positive control substance hexyl cinnamic aldehyde (25% (w/v) induced positive reactions and a SI of 4.87 could be determined, thus meeting the reliability criteria for the LLNA.
- Key result
- Parameter:
- SI
- Value:
- 1.07
- Test group / Remarks:
- 5% (w/v)
- Key result
- Parameter:
- SI
- Value:
- 2.1
- Test group / Remarks:
- 10% (w/v)
- Key result
- Parameter:
- SI
- Value:
- 2.36
- Test group / Remarks:
- 20% (w/v)
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
Please refer to table 1 under "any further information on results".
EC3 CALCULATION
The EC3 value could not be calculated, since all SI values were below 3.
CLINICAL OBSERVATIONS
No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.
BODY WEIGHTS
The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age. - Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- The test material was not a skin sensitiser.
CLP: not classified - Executive summary:
In a LLNA three groups each of four female mice were treated daily with the test item at concentrations of 5, 10, and 20% (w/v) in propylene glycol by topical application to the dorsum of each ear lobe (left and
right) for three consecutive days. A control group of four mice was treated with the vehicle (propylene glycol) only. All treated animals survived the scheduled study period and no signs of toxicity were
observed. The test material was found not to be a skin sensitiser.
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Positive control results:
- The positive control substance hexyl cinnamic aldehyde (25% (w/v) induced positive reactions and a SI of 4.87 could be determined, thus meeting the reliability criteria for the LLNA.
- Key result
- Parameter:
- SI
- Value:
- 1.07
- Test group / Remarks:
- 5% (w/v)
- Key result
- Parameter:
- SI
- Value:
- 2.1
- Test group / Remarks:
- 10% (w/v)
- Key result
- Parameter:
- SI
- Value:
- 2.36
- Test group / Remarks:
- 20% (w/v)
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
Please refer to table 1 under "any further information on results".
EC3 CALCULATION
The EC3 value could not be calculated, since all SI values were below 3.
CLINICAL OBSERVATIONS
No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.
BODY WEIGHTS
The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age. - Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- CLP: not classified
Referenceopen allclose all
Table 1 Calculation and results of individual data
Test item concentration % (w/v) | Measurement DPM | Calculation | Result | ||
DPM-BG | number of lymph nodes | DPM per lymph node | SI | ||
BG I | 35 | - | |||
BG II | 33 | - | |||
Vehicle control | 3816 | 3782 | 8 | 472.8 | - |
5 | 4098 | 4064 | 8 | 508.0 | 1.07 |
10 | 7963 | 7929 | 8 | 991.1 | 2.10 |
25 | 8959 | 8925 | 8 | 1115.6 | 2.36 |
BG = Background (1 mL 5% trichloracetic acid) in duplicate
Vehicle = propylene glycol
SI = Stimulation index
Table 2 Individual body weights
Animal No. | Dose group | Initial Weight (g) | weight prior to treatment with 3HTdR (g) | ||
Individual | Mean± SD | Individual | Mean± SD | ||
1 | 1 | 19.9 | 20.3 ± 0.9 | 21.2 | 21.2 ± 1.1 |
2 | 1 | 19.3 | 19.8 | ||
3 | 1 | 21.3 | 21.2 | ||
4 | 1 | 20.8 | 22.4 | ||
5 | 2 | 18.6 | 19.4 ± 1.1 | 20.3 | 21.1 ± 1.2 |
6 | 2 | 18.9 | 19.9 | ||
7 | 2 | 21.0 | 22.7 | ||
8 | 2 | 19.0 | 21.3 | ||
9 | 3 | 20.9 | 20.3 ± 0.5 | 21.0 | 20.6 ± 0.5 |
10 | 3 | 20.4 | 19.8 | ||
11 | 3 | 20.0 | 20.6 | ||
12 | 3 | 19.8 | 20.9 | ||
13 | 4 | 21.5 | 20.8 ± 1.5 | 22.1 | 21.0 ± 1.4 |
14 | 4 | 22.4 | 22.2 | ||
15 | 4 | 18.9 | 19.6 | ||
16 | 4 | 20.3 | 20.0 |
Table 1 Calculation and results of individual data
Test item concentration % (w/v) | Measurement DPM | Calculation | Result | ||
DPM-BG | number of lymph nodes | DPM per lymph node | SI | ||
BG I | 35 | - | |||
BG II | 33 | - | |||
Vehicle control | 3816 | 3782 | 8 | 472.8 | - |
5 | 4098 | 4064 | 8 | 508.0 | 1.07 |
10 | 7963 | 7929 | 8 | 991.1 | 2.10 |
25 | 8959 | 8925 | 8 | 1115.6 | 2.36 |
BG = Background (1 mL 5% trichloracetic acid) in duplicate
Vehicle = propylene glycol
SI = Stimulation index
Table 2 Individual body weights
Animal No. | Dose group | Initial Weight (g) | weight prior to treatment with 3HTdR (g) | ||
Individual | Mean± SD | Individual | Mean± SD | ||
1 | 1 | 19.9 | 20.3 ± 0.9 | 21.2 | 21.2 ± 1.1 |
2 | 1 | 19.3 | 19.8 | ||
3 | 1 | 21.3 | 21.2 | ||
4 | 1 | 20.8 | 22.4 | ||
5 | 2 | 18.6 | 19.4 ± 1.1 | 20.3 | 21.1 ± 1.2 |
6 | 2 | 18.9 | 19.9 | ||
7 | 2 | 21.0 | 22.7 | ||
8 | 2 | 19.0 | 21.3 | ||
9 | 3 | 20.9 | 20.3 ± 0.5 | 21.0 | 20.6 ± 0.5 |
10 | 3 | 20.4 | 19.8 | ||
11 | 3 | 20.0 | 20.6 | ||
12 | 3 | 19.8 | 20.9 | ||
13 | 4 | 21.5 | 20.8 ± 1.5 | 22.1 | 21.0 ± 1.4 |
14 | 4 | 22.4 | 22.2 | ||
15 | 4 | 18.9 | 19.6 | ||
16 | 4 | 20.3 | 20.0 |
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
Local lymph node assay: not a skin sensitiser: no classification warranted
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