Octene, hydroformylation products, high-boiling

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:

2009

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

Test material information

Constituent 1

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

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.