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EC number: 240-521-2 | CAS number: 16470-24-9
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to guidelines/standards
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 427 (Skin Absorption: In Vivo Method)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium 4,4'-bis[[6-anilino-4-[(2-hydroxyethyl)methylamino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
- EC Number:
- 237-600-9
- EC Name:
- Disodium 4,4'-bis[[6-anilino-4-[(2-hydroxyethyl)methylamino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
- Cas Number:
- 13863-31-5
- Molecular formula:
- C38H40N12Na2O8S2
- IUPAC Name:
- disodium 2,2'-ethene-1,2-diylbis[5-({4-anilino-6-[(2-hydroxyethyl)(methyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]
- Details on test material:
- - Specific activity (if radiolabelling): 10.5 µCi/mg
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14-C
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.16 kg (No. 7517), 2.56 kg (No. 7518), 2.74 kg (No. 7519)
- Housing: individually
- Individual metabolism cages: yes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: water and dodecylbenzene sulfonate
- Duration of exposure:
- 72 hours
- Doses:
- - Nominal doses: 2 mg/animal = 20 µg/square cm
- Dose volume: 1 mL - No. of animals per group:
- 3
- Control animals:
- no
- Details on study design:
- APPLICATION OF DOSE: evenly distributed using a syringe fitted with a blunted hypodermic needle. The water was evaporated with a hair-dryer
VEHICLE
- Justification for use and choice of vehicle (if other than water): dodecylbenzene sulfonate is used as wetting agent
- Amount(s) applied (volume or weight with unit): 1 mL water and 0.1 mg dodecylbenzene sulfonate
TEST SITE
- Preparation of test site: hair removed with electric veterinary clipper followed by a treatment with a commercial depilatory
- Area of exposure: 100 square cm
- Type of cover / wrap if used: aluminium foil, fixed with an elastic net sleeve. Finally protected with a plaster wrapped around the trunk
SITE PROTECTION / USE OF RESTRAINERS FOR PREVENTING INGESTION: yes: see Type of cover
REMOVAL OF TEST SUBSTANCE
- Removal of protecting device: 72 hours after application
- Washing procedures and type of cleansing agent: no
- Time after start of exposure: 72 hours
SAMPLE COLLECTION
- Collection of blood: yes
- Collection of urine and faeces: yes
- Collection of expired air: no
- Terminal procedure: killed by intraveneous injection of 0.3 ml T 61
- Analysis of organs: skeletal muscle, skin
SAMPLE PREPARATION AND ANALYSIS
Radioactivity was measured on a Packard Tricarb Scintillation Counter, Model 3375 or Model 3385. Quenching was corrected for by the AES channels ratio method or by the internal standard method.
Blood/Urine: 0.6 mL and 0.5 mL aliquots, respectively were adsorbed on cellulose powder and directly combusted using the Packard Tricarb Sample Oxidizer, Model 306.
Subcutaneous tissue/net sleeve: As it was difficult to obtain representative aliquots, these materials were totally combusted in several portions.
Faeces: The faeces were lyophilized, homogenized in a disc mill, model T 250 and aliquots of approximately 400 mg combusted.
Skin/Muscle: These materials were homogenized with water, 3 mL/g, using a Polytron mixer. After lyophilization the material was homogenized in the disc mill and aliquots of approximately 250 mg were combusted.
Aluminium foil: The aluminium foil was extracted with methanol under reflux. The extract was reduced in volume and aliquots measured in the counting medium.
For control purposes the total aluminium foil after extraction was combusted in an oxygen stream at 900°C. The CO2 liberated was absorbed in three traps each containing 10 mL ethanolamine/methanol (1.2/8.8 v/v). Radioactivity was measured after addition of 10 mL of the counting medium.
Plaster: The plaster was cut in small pieces, several of which were randomly selected to assemble aliquots of 500 mg. These aliquots were combusted as discribed for the aluminium foil.
Background measurements in blood, faeces and urine were carried out prior to application from each individual rabbit. Samples of skin, subcutaneous tissue and muscle for background measurement were taken from a control rabbit, maintained under experimental conditions, but without application of radioactive material. Samples from this animal were also used for fortified sample experiments to determine the recovery of radioactivity. For all materials the recovery was within 100 ± 5%, with exception of the plaster, where only 85% of the radioactivity was recovered. The values obtained were not corrected for 100% recovery.
Results and discussion
Any other information on results incl. tables
Table 1: Distribution of radioactivity in male rabbits three days after topical application of 20µg 14C-test substance / cm²
(values are given in percent of dose):
|
|
Animal Number |
|
||
|
Material |
7517 |
7518 |
7519 |
Average |
|
Plaster |
n.d. |
0.2 |
0.2 |
0.2 |
|
Net Sleeve |
n.d. |
0.8 |
0.3 |
0.6 |
|
Aluminium Foil |
33.2 |
38 |
33.4 |
34.9 |
|
Skin |
52.4 |
51.2 |
54.5 |
52.7 |
|
Subcutaneous Tissue |
0.4 |
0.1 |
0.2 |
0.2 |
Urine |
|
|
|
|
|
1st day |
0.6 |
0.6 |
0 |
0.4 |
|
2nd day |
< 0.1 |
0.1 |
n.m. |
< 0.1 |
|
3rd day |
< 0.1 |
< 0.1 |
0.8 |
0.3 |
|
Subtotal |
0.6 |
0.7 |
0.8 |
0.7 |
|
Faeces |
|
|
|
|
|
1st day |
0.3 |
0.1 |
0.6 |
0.3 |
|
2nd day |
0.2 |
1 |
0.2 |
0.5 |
|
3rd day |
0.8 |
0.2 |
n.m. |
0.3 |
|
Subtotal |
1.3 |
1.3 |
0.8 |
1.1 |
|
|
Total Recovery |
87.9 |
92.3 |
90.2 |
90.4 |
n.d. = not determined, n.m. = no material obtained
Table 2: Blood levels of radioactivity in male rabbits after topical application of 14C-test substance/ cm2
(values are given in percent of dose, present in the total blood volume, assuming that blodd represents 5% of the body weight.
|
Animal Number |
||
Elapsed Time (hours) |
7517 |
7518 |
7519 |
1 |
0.064 |
- |
0.02 |
1.5 |
- |
0.021 |
- |
2 |
0.066 |
- |
< LQ |
3.25 |
- |
< LQ |
- |
4 |
0.042 |
- |
< LQ |
6 |
- |
< LD |
- |
8 |
< LQ |
< LQ |
< LD |
24 |
< LD |
< LQ |
< LD |
30 |
- |
< LQ |
< LQ |
48 |
< LQ |
< LQ |
< LD |
72 |
< LQ |
< LD |
< LD |
LQ: Limit of quantitation: 0.016%, equivalent to 2.7 ppb
LD: Limit of detection: 0.006%, equivalent to 0.9 ppb
Applicant's summary and conclusion
- Conclusions:
- Test substance is not absorbed by rabbits after topical application as tested in this study.
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