1-(vinyloxy)octadecane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011-06-29 to 2011-07-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline compliant study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

(February 24, 1987)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

(30 May 2008)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

(August 1998)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nosan No. 8147 as this in line with OECD 402

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-(vinyloxy)octadecane

EC Number:

213-208-3

EC Name:

1-(vinyloxy)octadecane

Cas Number:

930-02-9

Molecular formula:

C20H40O

IUPAC Name:

1-(ethenyloxy)octadecane

Test material form:

other: colourless liquid

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, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: Male animals approx. 8 weeks, female animals approx. 12 weeks
- Weight at study initiation: Group 1 male: 228-244 g; Group 2 female: 196-210 g (± 20% of the mean weight)
- Housing: Single housing, Makrolon cage, type III
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water: Tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30–70
- Air changes: Fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 6.00 a.m.–6.00 p.m.

Administration / exposure

Vehicle:

olive oil

Remarks:

Ph.Eur.

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorsal and dorsolateral parts of the trunk
- % coverage: About 40 cm² (corresponds to at least 10% of the body surface)
- Type of wrap if used: Semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Warm water
- Time after start of exposure: Afterwards removal of the semi- occlusive dressing

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 8.33 mL/kg bw
- Concentration (if solution): 60 g/100 mL
- Constant volume or concentration used: Yes
- For solids, paste formed: No

VEHICLE
- Amount(s) applied: 100 mL

Duration of exposure:

24 hours

Doses:

5000 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: Observations everday; Body weight: Day 0, 7,14
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, scoring of skin findings

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No systemic clinical signs were observed during clinical examination.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information