Registration Dossier
Registration Dossier
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EC number: 271-237-7 | CAS number: 68526-89-6 A complex combination of hydrocarbons produced by the distillation of products from the hydrogenation of isononanal from the hydroformylation of octene. It consists predominantly of C9-10 primary aliphatic alcohols, C10-20 dimer alcohols, C>18 acetals and esters and C>18 acid sodium salts and boils in the range of approximately 200°C to 400°C (392°F to 752°F).
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bioassay-Labor fuer biologische Analytik GmbH, Heidelberg, Germany
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Octene, hydroformylation products, high-boiling
- EC Number:
- 271-237-7
- EC Name:
- Octene, hydroformylation products, high-boiling
- Cas Number:
- 68526-89-6
- Molecular formula:
- Unspecified
- IUPAC Name:
- Reaction products of octene, hydroformylation products of C8-alkenes, high boiling
- Details on test material:
- - Name of test material (as cited in study report): Oxooel 9N
- Physical state: Liquid / colorless, clear
- Analytical purity: >99 %
- Lot/batch No.: Tank 252 (25.01.2008)
- Test-item No.: 08/0015-1
- Homogeneity: The test-item was homogeneous by visual inspection.
- Storage condition of test material: Room temperature; under N2
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: Young adult animals (male animals approx. 8 weeks, female animals approx. 12 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight); mean(males): 233 g; mean(females): 214.4 g
- Housing: Single housing
- Diet: VRF1(P); SDS Special Diets Services, Altrip, Germany
- Water: Tap water ad libitum
- Acclimation period: Acclimatization period at least 5 days before the beginning of the experimental phase.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 26
- Humidity (%): 20 - 80
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: clipped skin (dorsal and dorso-lateral parts of the trunk); the application area comprised at least 10% of body surface area.
- Type of wrap if used: covering of the application site with a semiocclusive dressing (the bandage consists of four layers absorbent gauze, Ph. Eur. Lohmann GmbH & Co. KG and Fixomull stretch (adhesive fleece), Beiersdorf AG) for 24 hours;
REMOVAL OF TEST SUBSTANCE
- Washing: Rinsing of the application site with warm water.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.31 ml/kg - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
Clinical observations: Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
Scoring of skin findings: Individual readings 30 – 60 minutes after removal of the semiocclusive dressing (day 1), as a rule weekly thereafter and on the last day of observation. The evaluation of skin reactions was performed according to Draize, J.H. (1959): Appraisal of the safety of chemicals in foods, drugs and cosmetics.
Mortality: A check for any dead or moribund animal was made at least once each workday.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No signs of systemic toxicity or skin effects were observed in the animals and no local effects were observed.
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.
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