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EC number: 425-950-7 | CAS number: 187393-00-6
- 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
- Study period:
- March 12, 1997 through March 20, 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): CF-C-1607
- Physical state: yellow solid
- Analytical purity: >98%
- Lot/batch No.: 003
- Expiration date of the lot/batch: August 31, 1998
- Storage condition of test material: at room temperature (ca. 20°C) away from direct sunlight
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Birkendorferstrasse 65, D-88397 Biberach/Riss
- Age at study initiation: 15 weeks
- Weight at study initiation: Male: 2900 g; Females: 2823 - 2983 g
- Housing: Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls and wood for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Kliba 341 rabbit maintenance diet ad libitum (batch no. 75/97).
- Water (e.g. ad libitum): Community tap water· from Itingen, ad libitum, in water bowls
- Acclimation period: Four days under test conditions after health examination. Only animals without any visual signs of illness wree used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3°C
- Humidity (%): 40-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Moisted with bi-distilled water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 g per animal
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours following treatment
- Number of animals:
- 1 male, 2 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2 of the intact skin of the clipped area
- Type of wrap if used: A 2.5 cm x 2.5 cm patch of surgical gauze covered with a semi-occlusive dressing. The dressing was wrapped around theabdomen and anchored with tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time
- Time after start of exposure: 4 hours
SCORING SYSTEM: According to EEC Commission Directive 92/691EEC, July 31, 1992
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Application of the test article to healthy intact rabbit skin resulted in a primary irritation score of 0.00. Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
- Other effects:
- Reversible light yellow staining by the test article of the treated skin was observed.
Any other information on results incl. tables
Table 1. Body weight (g) of test animals.
Animal No. |
Sex |
First Day of Acclimatisation |
First Day of Treatment |
Last Day of Treatment |
16 |
Male |
2900 |
2971 |
2999 |
17 |
Female |
2983 |
3150 |
3351 |
18 |
Female |
2823 |
2966 |
3041 |
Table 2. Skin irritation scores - individual values.
Animal No. |
Sex |
Evaluation Interval |
Erythema |
Edema |
Cumulative |
|
Score |
Mean |
|||||
16 |
M |
1 hour |
0 |
0 |
0.00 |
0.00 |
17 |
F |
0 |
0 |
0.00 |
||
18 |
F |
0 |
0 |
0.00 |
||
16 |
M |
24 hours |
0 |
0 |
0.00 |
0.00 |
17 |
F |
0 |
0 |
0.00 |
||
18 |
F |
0 |
0 |
0.00 |
||
16 |
M |
48 hours |
0 |
0 |
0.00 |
0.00 |
17 |
F |
0 |
0 |
0.00 |
||
18 |
F |
0 |
0 |
0.00 |
||
16 |
M |
72 hours |
0 |
0 |
0.00 |
0.00 |
17 |
F |
0 |
0 |
0.00 |
||
18 |
F |
0 |
0 |
0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- Based on these observations and on the referred classification criteria, CGP-C-1607 is considered to be "not irritating" to rabbit skin.
- Executive summary:
The primary skin irritation potential of the test article was investigated by topical application of 0.5 g to 6 cm2 intact dorsal skin of each of three young adult New Zealand rabbits. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing by the number of figures. The primary irritation score was 0.00 (max. 8.0). Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. The test article caused reversible light yellow staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any measuring interval. Based upon the referred classification criteria, the test article is considered to be "not irritating" to rabbit skin.
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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