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EC number: 225-795-3 | CAS number: 5081-87-8
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2006-02-09 to 2006-02-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Well documented non-GLP study performed according to OECD Guideline for testing of Chemicals, Draft OECD Guideline 430, In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER), 27 March 2002.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draft OECD Guideline 430, In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER), 27 March 2002
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 3-(2-chloroethyl)(1H,3H)quinazoline-2,4-dione
- EC Number:
- 225-795-3
- EC Name:
- 3-(2-chloroethyl)(1H,3H)quinazoline-2,4-dione
- Cas Number:
- 5081-87-8
- Molecular formula:
- C10H9ClN2O2
- IUPAC Name:
- 3-(2-CHLOROETHYL)QUINAZOLINE-2,4(1H,3H)-DIONE
- Details on test material:
- - Name of test material (as cited in study report): T 1201
- Substance type: white to pale beige solid
- Physical state: solid
- Analytical purity: no data
- Purity test date: no data
- Lot/batch No.: 00464885 RT001201G1A251
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: room temperature, protected from moisture; kept away from direct sunlight
- Other:
Solubility:
0.09 g/L in water
26.7 g/L in acetone
7.9 g/L in ethanol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, 33178 Borchen
- Age at study initiation: 29 days
- Weight at study initiation: not applicable
- Housing: single, Makrolon Type II cage, with wire mesh top
- Diet (e.g. ad libitum): pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): artificial light 12h dark/12h light (6:00 am - 6:00 pm light)
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: concurrent negative control (deionised water) and positive control (hydrochloric acid (36% ~ 10 M) Reag. Ph Eur
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1305 g, 0.1105 g, and 0.1248 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 150 µL - Duration of treatment / exposure:
- 24 hours
- Observation period:
- not applicable
- Number of animals:
- Three skin discs were used for each test group
- Details on study design:
- - The test material was applied for 24 hours to the epidermal surfaces of rat skin discs. Corrosive materials are identified by their ability to produce a loss of normal stratum corneum integrity and barrier function, which is measured as a reduction in the inherent TER below a certain threshold level (5 kOhm). Irritant and non-corrosive materials do not reduce the TER below the threshold level. A dye-binding step is incorporated into the test procedure to verify the TER results, if the TER values of the test item are less than 5 kOhm. Surfactants and neutral organics may produce faltse positive artefacts in the TER assay due to enhanced permeability of the skin sample towards ions.
- TER measurements:
The TER was measured by using a low-voltage, alternating current impedance meter (WTW LF 330). Prior to measuring the electrical resistance, the surface tension of the skin was reduced by adding a sufficient volume of 70% ethanol to cover the epidermis. After a few seconds the ethanol was removed by inverting the tube, and the tissue was then hydrated by the addition of 3 mL magnesium sulphate solution (154 mM). The electrodes were placed on either side of the skin disc to take the conductivity measurement in µS/skin disc. The resistance values were calculated from conductivity by the following equation:
resistance (Ohm) = 1/conductivity (S)
The mean TER results are accepted on condition that concurrent positive and negative control values fall within the acceptable ranges for the method.The control substances and their associated resistance ranges for the methodology and apparatus used in this test are:
Positive control (10 M hydrochloric acid (36%)): 0.5 - 1 kOhm*
Negative control (deionised water): 8 - 25 kOhm*
*: values reflect the laboratory's historical data and - for the negative control - differ from the range given in the OECD Guideline. Since the range given in the guideline is only a suggestion, the acceptance range was established by the facility based on the own historical data. This does not affect the validity of the test system.
If the mean TER value obtained for the test item is greater than 5 kOhm, then it is classified as non-corrosive. If the TER value is less than or equal to 5 kOhm it is classified as corrosive.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Value:
- 12.59
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: mean, SD: 1.49
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- 1
- Value:
- 11.98
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- 2
- Value:
- 11.49
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- 3
- Value:
- 14.29
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Impedance measurement of all three skin discs treated with the test substance indicated no corrosive effect. The skin discs appeared macroscopically intact after treatment. An appropriate reference substance was used as positive control and showed a distinct increase in conductivity indicating that the test was sensitive and valid. The actual impedance values remained in the range given by the guideline and were far below the general threshold of 5 kOhm indicating a substantial corrosive potential of the positive control substance. The mean TER-value of the negative control of the experiment remained well within the acceptance range.
Summary TER-results:
Negative control: mean: 13.08 kOhm (SD: 4.67) - not corrosive
Negative control 1: 11.36 kOhm
Negative control 2: 10.64 kOhm
Negative control 3: 17.24 kOhm
Positive control: mean: 0.76 kOhm (SD: 0.07) - corrosive
Positive control 1: 0.83 kOhm
Positive control 2: 0.75 kOhm
Positive control 3: 0.69 kOhm
T 1201: mean: 12.59 kOhm (SD: 1.49) - not corrosive
T 1201 1: 11.98 kOhm
T 1201 2: 11.49 kOhm
T 1201 3: 14.29 kOhm
Any other information on results incl. tables
Sulforhodamine B Dye application and removal:
The assessment of dye penetration was not necessary, because the TER values of the test item T 1201 were greater than 5 kOhm.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- It was concluded that the test item did not corrode rat skin under the experimental conditions used. Both positive control and negative control reached typical impedance values as stated in the guideline and in the range of the laboratory's historical controls. Therefore, the test substance is considered to be non-corrosive in this TER test.
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