Registration Dossier
Registration Dossier
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EC number: 271-363-2 | CAS number: 68551-11-1 A complex combination of products produced by the distillation of products from the hydrogenation of butanal from the hydroformylation of propene. It consists predominantly of organic compounds such as aldehydes, alcohols, esters, ethers and carboxylic acids having carbon numbers in the range of C4-C32 and boiling in the range of approximately 143°C to 282°C (289°F to 540°F).
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:
- other: Acceptable, well-documented study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): Oxooel 740 roh
- Substance type: product mixture
- Physical state: yellowish brown liquid
- Composition of test material, percentage of components: 2,2,4-trimethyIpentanediol-1,3-mono-i-butyrat / 2-ethylhexandiol-1,3 / 2,2-dimethylhexandiol-1,3-mono-i-butyrate: 33%, 2,2-dimethylhexanediol-1,3-di-i-butyrate / 2-ethyIhexanediol-1,3-mono-n-butyrate: 22%, 1-ethylpentenyl (2)-4-propyl-5,5 dimethyl-dioxane-1,3 / C8-diol-mono-i-butyrate: 14%, i-di-n-butylacetale / 2-ethylhexanol: 13%, 2,2-dimethylhexanediol-1,3: 8%, n-butanol: 3%, 2-ethylhexyl-n-butyrate: 1.5%, 2,4-di-propyl-5,5-dimethyl-dioxane-1,3: 1.5%, trimer-n-butyraldehyd: 1.0%, n-butyl-n-butyrate: 0.6%, 2,2,4-trimethylpentanediol-1,3: 0.3%, 2-ethyl-4-methylpentanediol-1,3-n-i-butyrate: 0.3%, 4-methyl-2-ethylpentanol: 0.2%, n-di-n-butylacetal: 0.2%, 2-ethylhexyl-i-butyrate: 0.2%, 4-methyl-2-ethylpentenal / 2-ethylhexanal: 0.1%, i-di-i-butylacetal: 0.1%, 2-i-propyl-4-propyl-5,5-dimethyl-dioxane-1,3: 0.02%, trimer-i-butyraldehyd: 0.01%, phosphor: 0.0013%, unknown substances: 3%, water: 0.1%
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: mean(males): 2.94 kg, female: 3.11 kg
- Housing: single
- Diet: about 130 g Kliba 341, 4 mm/animal/day
- Water: about 250 mL tap water/animal/day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): about 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3 (2 males, 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: Test Patches are secured in position with a porous dressing (four layers of absorbent gauze + porous bandage)
REMOVAL OF TEST SUBSTANCE
- Washing: with lutrol and lutrol/water (1:1)
- Time after start of exposure: at the end of the exposure period of 4 h
SCORING SYSTEM: according to OECD guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no abnormalities detected
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no abnormalities detected
- Irritant / corrosive response data:
- No signs of irritation were found in all tested animals.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Classification: not irritating
- Executive summary:
The study is conducted according to OECD guideline 404 and reliable. A cloth (2.5 x 2.5 cm) soaked with test substance (about 0.5 mL) was applied onto the skin of three rabbits. After 4 h the test substance was washed away. No signs of irritation were observed.
Conclusion
Oxooel 740 is not irritant to the skin.
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