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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(February 24, 1987)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
(30 May 2008)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
(August 1998)
Deviations:
no
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

Constituent 1
Chemical structure
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

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