Octadecane-1,12-diol

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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Test guideline 3

Qualifier:

according to guideline

Guideline:

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

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nosan No. 8147

GLP compliance:

yes (incl. QA statement)

Remarks:

Bioassay Labor für biologische Analytik GmbH, 69120 Heidelberg, Germany

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Octadecane-1,12-diol

EC Number:

220-342-6

EC Name:

Octadecane-1,12-diol

Cas Number:

2726-73-0

Molecular formula:

C18H38O2

IUPAC Name:

octadecane-1,12-diol

Details on test material:

- Name of test material (as cited in study report): Sovermol 912
- Physical state: Solid white
- Storage condition of test material: Room temperature, Substances to avoid: strong oxidizing agents
- Analytical purity: 81.1 g/100 g
- Lot/batch No.: S30120009
- Expiry date: April 25, 2015

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, Germany
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 12 weeks
- Mean weight at study initiation (mean weight ± SD): males: 240.0 ± 7.78 and females 205.0 ± 6.78 g
- Housing: Single housing, Makrolon cage, type III with bedding (H 15005-29; Ssniff, Spezialitäten GmbH (Experimental Animal Diets Inc., 59494 Soest, Germany)) and enrichment (Wooden gnawing blocks (Type NGM E-022) ; ABEDD® LAB & VET Service GmbH, Hasnerstraße 84/6; 1160 Wien – Austria)
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water: Tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

corn oil

Details on dermal exposure:

TEST SITE
- Area of exposure: Single application to the clipped epidermis (dorsal and dorsolateral parts of the trunk).
- % coverage: approx. 10 (about 40 cm²)
- Type of wrap if used: semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: rinsing of the application site with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 5.00 g/kg bw
- Concentration: 40g/100 mL
- For solids, paste formed: yes
- Preparation test item: The test item was grounded with mortar and pestle. The test item preparation was produced for each application group shortly before application by stirring with a high speed homogenizer (Ultra-Turrax) and a magnetic stirrer. Additionally the homogeneity of the test item preparation during application was ensured by stirring with a magnetic stirrer.

Duration of exposure:

24 hours

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:
-- Clinical observations: Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter.
-- Scoring of skin findings: Individual readings 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), 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. The association of food and drug officials of the United States Austin, Texas.
-- Mortality: A check for any dead or moribund animals was made at least once each workday.
- Necropsy with gross-pathology examination was performed on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with gradually increasing concentrations.

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 systemic clinical signs were observed during clinical examination. No local skin effects were observed.

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:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study the median lethal dose (LD50) of the test substance after dermal application was found to be greater than 2000 mg/kg bw in male and female rats.

Executive summary:

The acute dermal toxicity test was conducted according to OECD 402 and compliant with GLP. 5 male and 5 female Wistar rats were exposed for 24 hours to a single dose of 2000 mg/kg bw test substance suspended in corn oil. On the dorsal and dorsolateral parts of the trunk an area of 40 cm2 (at least 10% of the body surface) was clipped and exposed to the test substance under semi-occlusive conditions. After 24 hours the application site was rinsed with warm water and animals were observed for 14 days. No mortality, systemic clinical effects, local skin effects and macroscopic pathologic abnormalities were observed. The mean body weight of the animals increased within the normal range throughout the study period with one exception in the female group however this stagnation is considered to be unspecific. Under the conditions of this study the median lethal dose (LD50) of the test substance after dermal application was found to be greater than 2000 mg/kg bw in male and female rats.