Registration Dossier
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EC number: 947-329-4 | CAS number: -
- 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
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted similar to OECD guideline 404. However some deviations occurred (e.g. 24 h occluded exposure, limited data on test substance).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report Date:
- 1978
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to
- Guideline:
- other: Draize test
- Deviations:
- yes
- Remarks:
- e.g. 24 h occluded exposure, limited data on test substance
- Qualifier:
- according to
- Guideline:
- other: patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study was conducted prior to implementation of GLP.
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rabbit
- Strain:
- other: Russian
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.0 to 2.3 kg
- Housing: Individually in metal cages
- Diet (ad libitum): Standard rabbit food - NAFAG Gossau SG
- Water (ad libitum)
- Acclimation period: At least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±1
- Humidity (%): 55±5
- Photoperiod (hrs dark / hrs light): 10/14
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 7 d
- Number of animals:
- 3 males and 3 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.61
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
Any other information on results incl. tables
Table 1: Details on results
Observation time | Rabbit No. | |||||||||||
1 | 2 | 3 | 4 | 5 | 6 | |||||||
er | ed | er | ed | er | ed | er | ed | er | ed | er | ed | |
24 h | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 1 | 2 | 1 | 1 | 1 |
48 h | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
72 h | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Mean value 24 + 48 + 72 h | 0.67 | 0 | 0.67 | 0 | 0.33 | 0.33 | 0.33 | 0.33 | 1.0 | 0.33 | 0.67 | 0.33 |
Mean value 24 + 48 + 72 h, all animals | 0.61 | 0.22 |
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er: erythema, ed: edema
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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