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Diss Factsheets
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EC number: 602-941-8 | CAS number: 123560-48-5
- 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
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Endpoint summary
Administrative data
Description of key information
The test item was concluded to be no skin sensitiser.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jul 02 - Sep 26, 2007
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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 Netherlands B.V. Postbus 6174 NL - 5960 AD Horst
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 19.4 +/- 0.8 g
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-85
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: day 1 To: day 5 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- pre test for signs of irritation: 1, 2.5, 5, and 10 % (v/v)
main test: 2.5, 5, and 10 % (v/v) - No. of animals per dose:
- pre test: 2
main test: 5 (f) per group (3 test groups, 1 control group) total 20 (f) - Details on study design:
- RANGE FINDING TESTS:
To determine the highest non-irritant test concentration or the highest technically applicable concentration, a pretest was performed in two mice on three consecutive days. The data of a solubility experiment showed that the highest test item concentration, which could be technically used was a 10 % solution. At concentrations of 1 and 2.5 % the treated mouse did not show any signs of irritation. At concentrations of 5 and 10 % the treated mouse showed reddening of the ear skin only after the third application of the test item. The test item in the main study was, therefore, assayed at 2.5, 5, and 10 %.
MAIN STUDYANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD 429
- Criteria used to consider a positive response: 3-fold greater response at one concentration in SI than control animals
TREATMENT PREPARATION AND ADMINISTRATION:
a) Topical application of 25 µL test item preparation (test group) or vehicle (control group)
b) five days after topical application: iv application of 3H-methyl thymidin
c) prior each treatment (a and b) ear thickness measurement
d) five hours after treatment (b) necropsy and analysis of the 3H thymidin incorporation in draining lymph nodes
e) method: pooled per animal - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Dunnets Test
- Positive control results:
- Conc. SI
5 %: 2.43
10 % 4.07
25 % 4.88 - Key result
- Parameter:
- SI
- Value:
- 1.6
- Test group / Remarks:
- Test Group 2.5 %
- Key result
- Parameter:
- SI
- Value:
- 2.02
- Test group / Remarks:
- Test Group: 5 %
- Key result
- Parameter:
- SI
- Value:
- 1.12
- Test group / Remarks:
- Test Group: 10 %
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
DPM per lymph node
Control: 793.6
2.5 %: 1267.1
5 %: 1599.8
10 %: 889.4
DETAILS ON STIMULATION INDEX CALCULATION
ratio of 3HTdR incorporated into lymph node cells of test lymph nodes relative to that recorded for control lymph nodes
EC3 CALCULATION
The EC3 value could not be calculated since all SIs were below 3.
CLINICAL OBSERVATIONS
No deaths occurred 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.
SIGNS OF TOXICITY
No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.
The measured ear thickness of all animals treated was recorded prior to the 1stapplication and prior to treatment with 3HTdR. A relevant increase in ear thickness gain was not observed after treatment with the test item. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was concluded to be no skin sensitiser.
- Executive summary:
In the study the test item was dissolved in acetone:olive oil (4+1) was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed using test item concentrations of 2.5, 5, and 10 %. The GLP study was performed according to OECD 429. The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. A relevant increase in ear thickness gain could not be observed after treatment with the test item. In this study Stimulation Indices (S.I.) of 1.60, 2.02, and 1.12 were determined with the test item at concentrations of 2.5, 5, and 10 % in acetone:olive oil (4 +1), respectively. Since the S.I. was not increased above 3 at any test group, and EC3 could not be determined. From the data it can be concluded that the test item is not a skin sensitiser under the conditions of this assay.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In the study the test item was dissolved in acetone:olive oil (4+1) was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed using test item concentrations of 2.5, 5, and 10 %. The GLP study was performed according to OECD 429. The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. A relevant increase in ear thickness gain could not be observed after treatment with the test item. In this study Stimulation Indices (S.I.) of 1.60, 2.02, and 1.12 were determined with the test item at concentrations of 2.5, 5, and 10 % in acetone:olive oil (4 +1), respectively. Since the S.I. was not increased above 3 at any test group, and EC3 could not be determined. From the data it can be concluded that the test item is not a skin sensitiser under the conditions of this assay.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin sensitisation, the test item does not require classification for skin sensitisation according to Regulation (EC) No 1272/2008 (CLP).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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