Petroleum gas oil fraction, co-processed with renewable hydrocarbons of plant and/or animal origin

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1979-09-19 to 1979-10-04

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.

Justification for type of information:

Read across justification included in Section 13

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1979-09-19 to 1979-10-04

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.

Justification for type of information:

Read across justification included in Section 13

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

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

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

no

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: L.I.T. Rabbitry
- Age at study initiation: adult
- Weight at study initiation: 2.0 to 2.5 kilograms
- Fasting period before study: no
- Housing: individually housed in stainless steel laboratory cages
- 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

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: rabbit's back
- % coverage: 30%
- Type of wrap if used: plastic wrap secured with porous adhesive tape, the entire trunk was wrapped with elastic tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was wiped to remove excess test material
- Time after start of exposure: 24 hours


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: no


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 of undiluted test material

No. of animals per sex per dose:

4 males and 4 females

Control animals:

not required

Details on study design:

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

Preliminary study:

none performed

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Remarks on result:

other: approx > 4300 mg/kg bw/day

Mortality:

No rabbits died during the study.

Clinical signs:

other: During the 14 day study, erythema followed by a drying and flaking of the skin was observed at the test site in all test rabbits. No signs of systemic toxicity were noted.

Gross pathology:

The gross post-mortem examinations at 14 days revealed four rabbits with congested kidneys, two with haemorrhages in the trachea, and one with a congested liver. None of these observations were found to be treatment-related.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 for diesel fuel was > 5 mL/kg bw (approx 4300 mg/kg bw).

Executive summary:

In an acute dermal toxicity study, 4 male and 4 female New Zealand white rabbits were shaved 24 hours prior to application of test material. This area constituted 30% of the total body surface area. Afterwards, the animals were returned to their stock cages for 24 hours to allow the skin to heal. On testing day, the exposure sites of four animals (2 males and 2 females) were abraded. Minor abrasions were made through the stratum corneum, but not the dermis. A single dose of 5 mL of undiluted test material per kilogram body weight was applied to gauze sponges backed with plastic wrap to help prevent evaporation of the test material. The sponges and plastic wrap were then taped to the shaved area of the rabbit's backs with adhesive tapes. The entire trunk was wrapped with elastic tape and the rabbits were then returned to their cages. After 24 hours, the bandaging was removed and the skin wiped with gauze sponges to remove excess test material. Animals were observed for mortality, local reactions, and behavioural abnormalities daily for 14 days. Body weights were recorded on days 0, 7, and 14. on day 14 all surviving rabbits were subjected to gross necropsy.

During the 14 day study, erythema followed by a drying and flaking of the skin was observed at the test site in all test rabbits. No signs of systemic toxicity were noted. None of the rabbits lost weight during the testing period. The gross post-mortem examinations at 14 days revealed four rabbits with congested kidneys, two with haemorrhages in the trachea, and one with a congested liver. None of these observations were found to be treatment-related. The test material is classified as practically nontoxic.

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.

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:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Fuels, diesel

EC Number:

269-822-7

EC Name:

Fuels, diesel

Cas Number:

68334-30-5

IUPAC Name:

Fuels, diesel

Constituent 2

Reference substance name:

Diesel fuel -marketplace sample

IUPAC Name:

Diesel fuel -marketplace sample

Test material form:

other: low viscosity liquid hydrocarbon

Details on test material:

- Name of test material (as cited in study report): API #79-6
- 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: 41.7% paraffins, 30.9% cycloparaffins, 27.4% aromatics
- 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: test material was stored in Elar's test material storage room and removed in 500 mL aliquots for storage in the Toxicology Department clinic.

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: L.I.T. Rabbitry
- Age at study initiation: adult
- Weight at study initiation: 2.0 to 2.5 kilograms
- Fasting period before study: no
- Housing: individually housed in stainless steel laboratory cages
- 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: rabbit's back
- % coverage: 30%
- Type of wrap if used: plastic wrap secured with porous adhesive tape, the entire trunk was wrapped with elastic tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was wiped to remove excess test material
- Time after start of exposure: 24 hours


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: no


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 of undiluted test material

No. of animals per sex per dose:

4 males and 4 females

Control animals:

not required

Details on study design:

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

Results and discussion

Preliminary study:

none performed

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:

No rabbits died during the study.

Clinical signs:

other: During the 14 day study, erythema followed by a drying and flaking of the skin was observed at the test site in all test rabbits. No signs of systemic toxicity were noted.

Gross pathology:

The gross post-mortem examinations at 14 days revealed four rabbits with congested kidneys, two with haemorrhages in the trachea, and one with a congested liver. None of these observations were found to be treatment-related.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 for diesel fuel was > 5 mL/kg bw (approx 4300 mg/kg bw).

Executive summary:

In an acute dermal toxicity study, 4 male and 4 female New Zealand white rabbits were shaved 24 hours prior to application of test material. This area constituted 30% of the total body surface area. Afterwards, the animals were returned to their stock cages for 24 hours to allow the skin to heal. On testing day, the exposure sites of four animals (2 males and 2 females) were abraded. Minor abrasions were made through the stratum corneum, but not the dermis. A single dose of 5 mL of undiluted test material per kilogram body weight was applied to gauze sponges backed with plastic wrap to help prevent evaporation of the test material. The sponges and plastic wrap were then taped to the shaved area of the rabbit's backs with adhesive tapes. The entire trunk was wrapped with elastic tape and the rabbits were then returned to their cages. After 24 hours, the bandaging was removed and the skin wiped with gauze sponges to remove excess test material. Animals were observed for mortality, local reactions, and behavioural abnormalities daily for 14 days. Body weights were recorded on days 0, 7, and 14. on day 14 all surviving rabbits were subjected to gross necropsy.

During the 14 day study, erythema followed by a drying and flaking of the skin was observed at the test site in all test rabbits. No signs of systemic toxicity were noted. None of the rabbits lost weight during the testing period. The gross post-mortem examinations at 14 days revealed four rabbits with congested kidneys, two with haemorrhages in the trachea, and one with a congested liver. None of these observations were found to be treatment-related. The test material is classified as practically nontoxic.

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.