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Diss Factsheets
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EC number: 245-524-2 | CAS number: 23251-72-1
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1999-07-10 to 2000-04-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is the result of a structural analogue substance used as read-across substance. Study is conducted according to Guidelines in a GLP certified laboratory.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The room temperature should be 20°C±3°C and not 22 ±3°C. This deviation is not thought to have affected the results of this study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The room temperature should be 20°C±3°C and not 22 ±3°C. This deviation is not thought to have affected the results of this study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- RA1
- IUPAC Name:
- RA1
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: Liquid
- Stability under test conditions: Maximum 365 days
- Storage condition of test material: At room temperature at about 20 ºC, 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: Elevage Scientifique des Dombes,
F-01400 Chatillon sur Charlaronne.
- Age at study initiation: Male: 15 weeks
Female: 15 weeks
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls with autoclaved wood and haysticks for chewing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water from Füllinsdorf ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 40 -70%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light.
IN-LIFE DATES: From: 16-08-1999 To: 19-08-1999
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml/animal
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 animals: 1 male, 2 female
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal area
- Type of wrap if used: Semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The area was washed with lukewarm tap water
- Time after start of exposure: 4 hours following application
SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours after removal of application
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Reversibility not applicable as no irritation seen
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours after removal of application
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Reversibility not applicable as no irritation seen
- Irritant / corrosive response data:
- The test article did not elicit any skin reactions at the appplication site at any of the observation times. The mean values from 24 to 72 hours were therefore 0/4 for erythema and 0/4 for oedema.
No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin. - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.
No staining by the test article of the treated skin was observed.
The body weights of all rabbits were considered to be with in the normal range of variability.
Any other information on results incl. tables
Table 1: Body Weights
Body Weights in grams |
||||
Animal No. |
Sex |
First Day of Acclimatization |
Day of Treatment |
Last Day of Observation |
10 |
Male |
2585 |
2752 |
2782 |
11 |
Female |
2503 |
2681 |
2679 |
12 |
Female |
2579 |
2612 |
2668 |
Table 2: Skin Irritation Scores - Individual Values
Animal Number |
Sex |
Evaluation Interval |
Erythema |
Oedema |
10 11 12 |
Male Female Female |
1 hour |
0 0 0 |
0 0 0 |
10 11 12 |
Male Female Female |
24 hours |
0 0 0 |
0 0 0 |
10 11 12 |
Male Female Female |
48 hours |
0 0 0 |
0 0 0 |
10 11 12 |
Male Female Female |
72 hours |
0 0 0 |
0 0 0 |
Table 3: Skin Irritation Scores - Mean values of 24, 48 and 72 hours
Animal Number |
Sex |
Erythema N |
Oedema N |
10 11 12 |
Male Female Female |
0.00 3 0.00 3 0.00 3 |
0.00 3 0.00 3 0.00 3 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the classification criteria, RA1 is considered to be "not irritating" to rabbit skin following a 4-hr application.
- Executive summary:
RA1 was tested for its dermal irritancy potential. 0.5 ml of test substance was applied to the skin of 3 White New Zealand rabbits for 4 hours using a semi-occlusive dressing. Following removal of the dressing and washing off the test substance, the animals were observed for 72 hours for signs of skin irritation, clinical signs, and changes in body weight.
The test article did not elicit any skin reactions at the appplication site at any of the observation times. The mean values at 24, 28 and 72 hours were 0/4 for erythema and 0/4 for oedema. The test substance did not induce any clinical signs in the treatment animals and all animals gained body weight during the course of the study.
Based on these results, RA1 is not considered to be a skin irritant.
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