Petroleum heavy cycle oil, co-processed (catalytic cracking) with renewable hydrocarbons of plant 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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Near-guideline, GLP-compliant study. Adequate for assessment.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Near-guideline, GLP-compliant study. Adequate for assessment.

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)

Principles of method if other than guideline:

The test substance was administered dermally to male and female rabbit and animals observed for 14 days. Body weights were recorded the prior to treatment and again at gross necropsy on day 14.

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Body weight at study initiation: approx.2.6 kg

IN-LIFE DATES: From: 15 January 1982 To: 29 January 1982.

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Fur was clipped from a region of skin (equivalent to around 10% of the total body area) approx. 18 hr prior to dosing. The test site from 2 males and 2 females was lightly abraded immiediately before treatment.

Duration of exposure:

24 hr

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2 male / 2 female - intact skin
2 male / 2 female - abraded skin

Control animals:

not required

Details on study design:

The test substance was administered dermally to male and female rabbit and animals observed for 14 days. Body weights were recorded the prior to treatment and again at gross necropsy on day 14.

Statistics:

None used

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No

Clinical signs:

other: No

Gross pathology:

No abnormalities detected

Other findings:

None

No deaths resulted and there were no significant clinical signs. Any erythema that may have been present after patch removal was obscured by the black tarry test substance.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Dermal LD50 > 2000 mg/kg bw

Executive summary:

The test substance was administered to clipped skin from groups of male and female NW rabbits (n = 4/sex) at 2000 mg/kg bw followed by a 14 day observation period.

The test site from 2 animals per sex was lightly abraded prior to dosing. There were no clinical signs or evidence of systemic toxicity, and all animals gained weight during the post-treatment period. No lesions were present at scheduled necropsy. 

The acute dermal LD₅₀ was >2000 mg/kg bw in both sexes.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

Principles of method if other than guideline:

The test substance was administered dermally to male and female rabbit and animals observed for 14 days. Body weights were recorded the prior to treatment and again at gross necropsy on day 14.

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

64741-62-4

Cas Number:

64741-62-4

IUPAC Name:

64741-62-4

Test material form:

other: Viscous hydrocarbon liquid

Details on test material:

Catalytic cracked clarified oil (CCCO), API 81-15, CAS No. 64741-62-4.
Dark brown viscous liquid

Data below taken from American Petroleum Institute (1985d). In-vivo sister chromatid exchange (SCE) assay. Catalytic cracked clarified oil, API Sample 81-15, CAS No. 64741-62-4. Testing laboratory: Microbiological Associates Inc., 5221 River Road, Bethesda, MD 20816, USA. Owner company: American Petroleum Institute, 2101 L Street, Northwest, Washington, DC 20037, USA. Study number: 32-32754. Report date: 1985-11-25.

Gravity API: 0.1
Specific gravity: 1.0753
Viscosity in SUS @ 210 °F: 56.1
Flash Point °F: 396
Sulfur wt %: 1.1
Pour Pt °F: 35
Asphaltenes % (MN 596): 4.2
Carbon residue wt %: 4.6
Ash wt %: 0.05

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Body weight at study initiation: approx.2.6 kg

IN-LIFE DATES: From: 15 January 1982 To: 29 January 1982.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Fur was clipped from a region of skin (equivalent to around 10% of the total body area) approx. 18 hr prior to dosing. The test site from 2 males and 2 females was lightly abraded immiediately before treatment.

Duration of exposure:

24 hr

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2 male / 2 female - intact skin
2 male / 2 female - abraded skin

Control animals:

not required

Details on study design:

The test substance was administered dermally to male and female rabbit and animals observed for 14 days. Body weights were recorded the prior to treatment and again at gross necropsy on day 14.

Statistics:

None used

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No

Clinical signs:

other: No

Gross pathology:

No abnormalities detected

Other findings:

None

Any other information on results incl. tables

No deaths resulted and there were no significant clinical signs. Any erythema that may have been present after patch removal was obscured by the black tarry test substance.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Dermal LD50 > 2000 mg/kg bw

Executive summary:

The test substance was administered to clipped skin from groups of male and female NW rabbits (n = 4/sex) at 2000 mg/kg bw followed by a 14 day observation period.

The test site from 2 animals per sex was lightly abraded prior to dosing. There were no clinical signs or evidence of systemic toxicity, and all animals gained weight during the post-treatment period. No lesions were present at scheduled necropsy. 

The acute dermal LD₅₀ was >2000 mg/kg bw in both sexes.