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EC number: 939-727-1 | 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
- 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:
- 16-31 October 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP study conducted in compliance with OECD Guideline 404 with minor deviations: age of the animals not reported; no details on the housing conditions; individual animal weights not reported
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- age of the animals not reported; no details on the housing conditions; individual animal weights not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- COFRAC accredidation on technical ability
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 9022-76-8
- Details on test material:
- - Name of test material (as cited in study report): CHIMEXANE NB - Batch M 752
- Physical state: Yellow viscous liquid
- Analytical purity: 98 %
- Lot/batch No.: M 752
- Date received: 09 October 1995
- Storage condition of test material: At room temperature, away from the light and heat
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bertho, Yffiniac, France
- Average weight at study initiation: 2.3 kg
- Housing: Individual housing on floor grid
- Diet (e.g. ad libitum): Complete pelleted rabbit maintenance diet Energie H326, COFNA (Tours, France)
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- In accordance with the requirements of the 86/609/EEC guideline.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 d
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal area of the trunk of the animals
- Type of wrap if used: Test substance was applied directly to the clipped skin under a gauze pad (2 cm X 2 cm) and held in place by means of a 5 x 5 cm wide ‘Micropore’ fastening tape. Then the animal's trunk was wrapped with a 10 cm wide stretch tape (varicose vein tape) fastened by adhesive tape of the same width.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After removal of the dressings, the residual test substance was removed using absorbent paper moistened with water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Scoring system same as recommended by OECD Guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritant / corrosive response data:
- Well defined erythema to moderate-severe erythema associated with slight to moderate oedema was observed in all 3 animals. These reactions decreased after 7 days and were completely reversible in one rabbit. Very slight erythema and oedema were perceptible respectively in one and two animals up to Day 15.
- Other effects:
- None
Any other information on results incl. tables
Table 7.3.1/1: Individual skin reactions
Animal no. |
Observation time |
Mean (24, 48 and 72 h) |
|||
1 h |
24 h |
48 h |
72 h |
||
Erythema |
|||||
1 |
2 |
3 |
3 |
3 |
3 |
2 |
2 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
2 |
2.7 |
Oedema |
|||||
1 |
2 |
2 |
3 |
3 |
2.7 |
2 |
2 |
3 |
3 |
3 |
3 |
3 |
2 |
3 |
3 |
2 |
2.7 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, CHIMEXANE NB - Batch M 752 is classified as ‘R38 Irritating to skin’ according to the criteria of Annex VI of the Directive 67/548/EEC and ‘Category 2: skin Irritant’ according to CLP Regulation (EC) N° (1272-2008).
- Executive summary:
In a primary dermal irritation study performed according to OECD Guideline 404 , three male New Zealand White rabbits were dermally exposed to 0.5 mL of CHIMEXANE NB - Batch M 752, under a semi-occlusive dressing (2 cm x 2 cm) for 4 h to clipped skin of the dorsal area of the trunk. After removal of the dressings, the residual test substance was removed using absorbent paper moistened with water. Irritation was scored as outlined in the OECD Guideline 404 at approximately 1, 24, 48 and 72 h after removal of the dressing and then daily until the end of the observation period (Day 15).
Well defined erythema to moderate-severe erythema associated with slight to moderate oedema was observed in all 3 animals. These reactions decreased after 7 days and were completely reversible in one rabbit. Very slight erythema and oedema were perceptible respectively in one and two animals up to Day 15. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 3, 3, 2.7 for erythema and 2.7, 3, 2.7 for oedema score, respectively. In this study, CHIMEXANE NB - Batch M 752 is a skin irritant on male rabbits.
Under the test conditions, CHIMEXANE NB - Batch M 752 is classified as ‘R38 Irritating to skin’ according to the criteria of Annex VI of the Directive 67/548/EEC and ‘Category 2: skin Irritant’ according to CLP Regulation (EC) N° (1272-2008).
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