Hydrotreated mixture of middle straight-run gas oil and soybean oil

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

short-term repeated dose toxicity: inhalation

Type of information:

migrated 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: Standard method, GLP-compliant, adequate experimental details for assessment

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)

Principles of method if other than guideline:

Whole-body exposure to vapour/aerosol. Method generally in accordance with OECD GL 412 (5 days of exposure/week). Groups 2 and 3 exposed to different test samples.

GLP compliance:

yes

Limit test:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

API 81-09
API 81-10

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

whole body

Vehicle:

air

Remarks on MMAD:

MMAD / GSD: 3.2 - 3.6 microns equivalent aerodynamic diameter (aerosol)

Details on inhalation exposure:

Method of exposure:
Whole-body inhalation
Mass median aerodynamic diameter:
3.2 - 3.6 microns equivalent aerodynamic diameter (aerosol)

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

Test duration: 28 days

Frequency of treatment:

Duration of exposure per day: 6 hours
Dosing regime: 5 days/week

No. of animals per sex per dose:

Male: 20 animals at mg/l
Male: 20 animals at .023 mg/l
Male: 20 animals at .024 mg/l
Female: 20 animals at mg/l
Female: 20 animals at .023 mg/l
Female: 20 animals at .024 mg/l

Control animals:

yes

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Organ weight findings including organ / body weight ratios:

effects observed, treatment-related

Description (incidence and severity):

see details on results

Details on results:

Clinical observations:
No exposure-related clinical signs or bodyweight effects
were observed.

Laboratory findings:
No haematology changes were seen in test animals, except for
moderately increased leukocyte counts seen in both sexes of
Group 3 (difference from controls statistically
significant). No differences in serum biochemical
parameters which were considered treatment-related were
reported.

Effects in organs:
Statistically significant absolute and/or relative organ
weight variations were observed in males (Group 2: lung,
brain and body, Group 3: kidney, liver, testis) and in
females (Group 2: lung, liver, pituitary). In the absence
of microscopic or other macroscopic changes, these were
considered not toxicologically significant.

Microscopic pathology revealed changes in the nasal tissues
of Group 2 male and female rats: subacute inflammation of
the anterior nasal cavity mucosa (trace in 7/20 males, 3/20
females and mild in 10/20 males, 12/20 females), with the
nasal epithelium remaining intact. Slight to mild septal
inflammatory change and increased alveolar macrophages
occurred in controls but incidence was slightly increased in
both the Group 2 and Group 3 animals

Effect levels

Dose descriptor:

NOAEL

Effect level:

23 mg/m³ air (nominal)

Based on:

test mat.

Basis for effect level:

other: exposure duration: 6 hours/day

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

Reproductive toxicity findings: Statistically significant increase in absolute/relative weight of the testes were recorded, however, no adverse findings were recorded during microscopic examination. Female reproductive organs (uterus, ovary) were also microscopically exmained: no adversed findings recorded.