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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study is considered reliable with restrictions since the publication is well reported and contains sufficiently data for assessment, but is conducted for read-across data. Read-across justification: Based on the chemical composition, the renewable hydrocarbons produced from raw materials such as fatty acid rich oil like Crude Tall Oil (CTO) or triglyserides, using a hydrotreatment process have similar hydrocarbon fractions and they contain the same critical constituents than fossil diesel fuels. According to the identified hydrocarbon blocks, the typical carbon number ranges and the physicochemical properties, the renewable hydrocarbons with diesel type fractions can be considered as having structural similarities and similar behaviour in contact with water and in the physiological processes than the analogue source substances (fossil diesel fuels). Their irritation properties, skin sensitisation property as well as acute and long-term adverse effects to human health is similar. Therefore, and in order to avoid the unnecessary animal testing, the read-across data from the analogue fossil diesel fuels is used to evaluate skin and eye irritation, the genetic toxicity, carcinogenicity, developmental toxicity and short term and/or long-term toxicological effects of the target substance.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Groups of five male and five female mice were administered a single 0.5-ml (dermal application of 5,000, 10,000,20,000, 30,000, or 40,000 mg/kg marine diesel fuel in 96% ethanol to the clipped dorsal interscapular region.
Test type:
other: modification of the standard method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding: Laboratories
- Age at study initiation: 9 weeks
- Housing: Mice were housed five per cage
- Diet (e.g. ad libitum): feed ad libitum
- Water (e.g. ad libitum): water (acidified to pH 2.5) ad libitum
- Acclimation period: for 4 weeks before the studies began

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 74" +/- 2
- Humidity (%): 30-70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
not specified
Vehicle:
ethanol
Remarks:
40 000 mg/kg dose applied as the neat chemical
Details on dermal exposure:
TEST SITE
clipped dorsal interscapular region.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

TEST MATERIAL
- Amount(s) applied (volume): 0.5 ml
- Constant volume: yes

VEHICLE
- ethanol purity 95 %
Duration of exposure:
Single dose, no washing of the substance performed.
Doses:
5,000, 10,000,20,000, 30,000, or 40,000 mg/kg marine diesel fuel in 96% ethanol to the clipped dorsal interscapular region.
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: daily, weighed on day of dosing
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 40 000 mg/kg bw
Based on:
test mat.
Mortality:
not observed
Clinical signs:
no compound related signs of toxicity
Body weight:
not measured during the study
Gross pathology:
not performed
Other findings:
not reported

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50(mouse, male/female) for marine diesel fuel is 40 000 mg/kg/day after single exposure.
Executive summary:

The acute dermal toxicity of marine diesel fuel was investigated in male and female mice following a single dermal application of the test substance. A LD50 of 40 000 mg/kg/day was determined for the diesel marine oil; the highest concentration tested. No mortality was recorded for the test substances at any dose studied.

The study was conducted for the read-across substance. This study is considered reliable with restrictions since the publication is well reported and contains sufficiently data for assessment.