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Administrative data

Description of key information

Oral: The acute oral LD50 of 1-(vinyloxy)octadecane was determined to be greater than 5000 mg/kg bw in rats.
Dermal: The median lethal dose (LD50) of 1-(vinyloxy)octadecane after dermal application was found to be greater than 5000 mg/kg bw in male and female rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987-12-17 to 1988-02-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Equivalent or similar to OECD guideline 401. No GLP.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
Deviations:
not specified
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Thomae GmbH; D-7950 Biberach; Germany
- Weight at study initiation: Males: 189 g; Females: 180 g
- Fasting period before study: about 16 hours
- Housing: Stainless steel wire mesh cages; type DK-III (Becker Co., Castrop-Rauxel, Germany)
- Diet: Kliba Labordiät 343, Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland, ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12 (6 .00 - 18 .00 hours/18 .00 - 6 .00 hours )
Route of administration:
oral: gavage
Vehicle:
other: olive oil
Details on oral exposure:
FASTING PERIOD
- Animals were given no feed about 16 hours before administration, but water was available at libitum

VEHICLE
- Test substance formulation with: olive oil
- Concentration in vehicle: 50 (w/v)
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: test substance is insoluble in water

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg


Doses:
5000 mg/kg
No. of animals per sex per dose:
10 (5 males/5 females) per dose
Control animals:
no
Details on study design:
- Time of day of observation: in the morning
- Duration of observation period following administration: 18 days
- Frequency of observations and weighing: observation: daily; weighing: day 0, 6 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathological examination
Statistics:
NA
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities
Clinical signs:
No clinical signs
Body weight:
No abnormalities
Gross pathology:
No abnormalities
Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
5 000 mg/kg bw
Quality of whole database:
On GLP and guideline study available.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
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.
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(February 24, 1987)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
(30 May 2008)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
(August 1998)
Deviations:
no
Qualifier:
according to
Guideline:
other: Japan MAFF Testing Guideline of 12 Nosan No. 8147 as this in line with OECD 402
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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.

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
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
No systemic clinical signs were observed during clinical examination.
Body weight:
The mean body weight of the male animals increased within the normal range throughout the study period.
The mean body weight of the female animals did not adequately increase during the first post-exposure observation week, but increased during the second week. This reduced weight gain in females during the first week is considered to be incidental and not treatment related as no other effects were observed in all treated animals of all dose groups.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
5 000 mg/kg bw

Additional information

Oral:

In the key study, the test article 1-(vinyloxy)octadecane was administered by gavage in a single dose of 5000 mg/kg bw in olive oil to 10 Wistar rats (5/sex). Study duration was 18 days. No animals died during the study period. No pathological findings were noted at terminal necropsy. Based on this findings, the acute oral LD50 of the test article 1-(vinyloxy)octadecane was estimated to be greater than 5000 mg/kg bw in male and female rats (BASF, 1988).

Dermal

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 5000 mg/kg bw of 1-(vinyloxy)octadecane (as solution in olive oil Ph.Eur.) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi- occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days. No signs of systemic toxicity were observed in the animals, no macroscopic pathologic abnormalities and no mortality occurred. Accordingly, the acute dermal median lethal dose (LD50) was determined to be > 5000 mg/kg bw (BASF SE, 2011).


Justification for selection of acute toxicity – oral endpoint
GLP and guideline compliant study.

Justification for selection of acute toxicity – dermal endpoint
GLP and guideline compliant study.

Justification for classification or non-classification

Based on the test results (oral + dermal LD50 > 5000 mg/kg bw), 1 -(vinyloxy)octadecane has not to be classified with regard to acute oral and dermal toxicity according to Regulation (EC) No 1272/2008 (CLP, GHS).