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EC number: 249-171-5 | CAS number: 28706-25-4
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EPA guideline (§ 163.81-5 "Primary dermal irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978)
- GLP compliance:
- no
- Remarks:
- pre-GLP
Test material
- Reference substance name:
- FAT 11178/B
- IUPAC Name:
- FAT 11178/B
- Details on test material:
- - Name of test material (as cited in study report): FAT 11178/B
- Physical appearance: red powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Exp. Toxicology Sisseln, CIBA-Geigy Ltd.
- Age at study initiation: adult animals
- Weight at study initiation: 2 - 3 kg
- Housing: single housing in metal cages
- Diet: standard rabbit food ad libitum (NAFAG, No. 814, Gossau SG)
- Water: ad libitum
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 14 / 10
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved intact and scarified skin
- Vehicle:
- other: polyethylene glycol (PEG 400) + saline 0.9 % (70 : 30 parts)
- Controls:
- other: untreated skin of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: 50% - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 6 (3 males + 3 females)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm on back and flank
- Type of wrap if used: impermeable
SCORING SYSTEM: according to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No irritant response data after a 24-hours occlusive exposure to intact skin. Grade 1 edema was noted after 24 and 48 h for some animals with abraded skin.
Any other information on results incl. tables
Individual cutaneous examinations and mean values (24-hour exposure, occlusive, intact skin):
Readings |
Animal |
Exposure period: 24 h, occlusive |
|
Erythema |
Edema |
||
24 h |
01 |
0 |
0 |
02 |
0 |
0 |
|
03 |
0 |
0 |
|
04 |
0 |
0 |
|
05 |
0 |
0 |
|
06 |
0 |
0 |
|
48 h |
01 |
0 |
0 |
02 |
0 |
0 |
|
03 |
0 |
0 |
|
04 |
0 |
0 |
|
05 |
0 |
0 |
|
06 |
0 |
0 |
|
72 h |
01 |
0 |
0 |
02 |
0 |
0 |
|
03 |
0 |
0 |
|
04 |
0 |
0 |
|
05 |
0 |
0 |
|
06 |
0 |
0 |
|
Mean (24, 48, 72 h) |
01 |
0 |
0 |
02 |
0 |
0 |
|
03 |
0 |
0 |
|
04 |
0 |
0 |
|
05 |
0 |
0 |
|
06 |
0 |
0 |
|
Mean (24, 48, 72 h) |
|
0.0 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- The test material is not irritating to the rabbit skin.
- Executive summary:
The test item contained 89% active ingredient and 10% urea and was applied at a concentration of 50% in vehicle (propylene glycol and saline, 70:30 parts). Three male and female New Zealand rabbits were shaved on the back. The left side was abraded. Gauze patches of 6.25 cm² were loaded with 0.5 g of the test item. Both the abraded and non abraded sites were treated and covered with an impermeable material for 24h. The skin irritation was assessed after 1, 2, 3, 4 and 7 days. Grade 1 edema was noted after 24 and 48 h for some animals with abraded skin only. Erythema could not be assessed due to the coloration by the dye.
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