Middle distillate from refinery proces cofeeding vegetable oil

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-06-15 to 1992-03-26

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because it is an acceptable and a well-documented study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Naval Distillate (CAS# 68334-30-5)

IUPAC Name:

Naval Distillate (CAS# 68334-30-5)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Dermal irritation:

effects observed, treatment-related

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

not examined

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

no effects observed

Effect levels

1

Dose descriptor:

NOEL

Remarks:

systemic

Effect level:

0.5 other: ml/kg

Sex:

male/female

2

Dose descriptor:

NOEL

Effect level:

0 other: ml/kg

Sex:

male/female

Basis for effect level:

other: based on dermal irritation

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

The NOEL level based on dermal irritation was 0.0001 ml/kg and a NOEL of 0.5 ml/kg was calculated for systemic toxicity.

Executive summary:

In a repeated dose oral toxicity study Naval distillate was administered to male and female Sprague Dawley rats at dose levels of 0.0001, 0.005, and 0.5 mL/kg were administered 5 days/week over a 4 week period.

The test material produced slight dermal irritation at a dose of 0.005 mL/kg and severe irritation at a dose of 0.50 mL/kg as evidenced by grossly visible dermal irritation and microscopic changes in the skin. A dose-dependent decrease in mean trglyceride was noted in males at a dose of 0.50 mL/kg. No other treatment related effects were observed in any of the parameters evaluated. No treatment-related effects were noted in examination of the weight and histopathology of testes and ovaries.

The NOEL level based on dermal irritation was 0.0001 mL/kg and a NOEL of 0.5 mL/kg was calculated for systemic toxicity.

This study received a Klimisch score of two and is classified as reliable with restriction because it is an acceptable and a well-documented study report.