Middle distillate from refinery proces cofeeding vegetable oil

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979-05-21 to 1979-06-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restriction because it was conducted according to or similar to guideline study OECD 434.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

#2 home heating oil (50% catalytically-cracked)

IUPAC Name:

#2 home heating oil (50% catalytically-cracked)

Details on test material:

- Name of test material (as cited in study report): API #78-4, #2 home heating oil (50% cat)
- Substance type: petroleum distillation product composed of hydrocarbon chains
- Physical state: liquid
- Analytical purity: not provided by sponsor
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: 50% virgin gas oil and 50% cracked gas oil
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: not reported
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not provided by sponsor
- Storage condition of test material: stored in Elar's test material storage room

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Pel-Freez Laboratories
- Age at study initiation: adult
- Weight at study initiation: 2 to 3.8 kg
- Fasting period before study: not reported
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported


IN-LIFE DATES: not reported

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: 30%
- Type of wrap if used: gauze sponges backed with Saran Wrap taped with adhesive tape and wrapped with Conform elastic tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
- Time after start of exposure: not reported


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 mL
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes
- For solids, paste formed: liquid used


VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle used
- Concentration (if solution): no vehicle used
- Lot/batch no. (if required): no vehicle used
- Purity: no vehicle used

Duration of exposure:

24 hours

Doses:

5 mL

No. of animals per sex per dose:

8 rabbits (4 males and 4 females)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: recorded on days 0, 7, and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Remarks on result:

other: (approx > 4300 mg/kg bw/day)

Mortality:

One animal died on day 7, but cause of death is not believed to be compound related.

Clinical signs:

other: All animals showed signs of erythema upon bandage removal. Dry cracked skin was noted in all test animals in later observations. There were no treatment-related signs of systemic toxicity in any rabbits during the duration of the study.

Gross pathology:

Five rabbits exhibited congested lungs, and one rabbit showed a large maxillary abscess on the right side of its head and a slightly congested liver. These observations are not believed to be related to the test substance.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute dermal toxicity study, the test material caused skin irritation in rabbits, but resulted in no obvious test substance related signs of systemic toxicity during the 14 day observation period or at necropsy. Based on the lack of mortality, the LD50 is > 5 mL/kg bw/day (approx > 4300 mg/kg bw/day). The test material is not classified according to EU criteria.

Executive summary:

In an acute dermal toxicity study, eight rabbits (4 male and 4 female) were shaved free of hair 24 hours prior to test material application and then returned to their cages for 24 hours for recovery. The expose sites of four rabbits (2 males and 2 females) were abraded. Minor incisions were made to the stratum corneum, but did not disturb the dermis. A single dose of 5 mL/kg bw of #2 home heating oil (50% cat) was applied to gauze sponges backed with Saran Wrap. These sponges were taped to the shaved area of the rabbit's' backs with adhesive tape. Then the entire trunk was wrapped with Conform elastic tape and the rabbits were returned to their cages. After 24 hours the bandaging was removed and the exposure sites were examined for reactions. Animals were observed for mortality and other toxic effects daily for the remainder of the study (14 days). Body weights were recorded on days 0, 7, and 14. On day 14 all rabbits were euthanized and subjected to gross necropsy.

One animal died on day 7, but cause of death is not believed to be compound related. All animals showed signs of erythema upon bandage removal. Dry cracked skin was noted in all test animals in later observations. There were no treatment-related signs of systemic toxicity in any rabbits during the duration of the study. Five rabbits exhibited congested lungs, and one rabbit showed a large maxillary abscess on the right side of its head and a slightly congested liver. These observations are not believed to be related to the test substance. Based on the lack of mortality, the LD50 is > 5 mL/kg bw/day (approx > 4300 mg/kg bw/day) and the test material is not classified according to EU regulations.

This study has a Klimisch score of 1 and is classified as reliable without restriction because it was conducted according to or similar to guideline study OECD 434.