Registration Dossier

Administrative data

Endpoint:
acute 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 equivalent to EC method, GLP-compliant, adequate experimental details for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Physical form of substance: L iquid
Mass median aerodynamic diameter (for liq.+solid aerosol):
2.05 - 2.40 microns

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetrically
Duration of exposure:
4 h
Concentrations:
0.01 (air control), 1.05, 1.60, 2.25, 3.22, 5.39 mg/L
No. of animals per sex per dose:
5 male and 5 female per dose
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
ca. 1.78 mg/L air
95% CL:
1.44 - 2.22
Exp. duration:
4 h
Mortality:
Male: 1.05 mg/L; Number of animals: ; Number of deaths: 0
Male: 1.6 mg/L; Number of animals: ; Number of deaths: 0
Male: 2.25 mg/L; Number of animals: ; Number of deaths: 4
Male: 3.22 mg/L; Number of animals: ; Number of deaths: 4
Male: 5.39 mg/L; Number of animals: ; Number of deaths: 5
Male: 0 mg/L; Number of animals: ; Number of deaths: 0
Female: 1.05 mg/L; Number of animals: ; Number of deaths: 0
Female: 1.6 mg/L; Number of animals: ; Number of deaths: 0
Female: 2.25 mg/L; Number of animals: ; Number of deaths: 5
Female: 3.22 mg/L; Number of animals: ; Number of deaths: 5
Female: 5.39 mg/L; Number of animals: ; Number of deaths: 5
Female: 0 mg/L; Number of animals: ; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
Groups 1-6 (exposure concentrations as indicated above)
mortalities 0, 40, 90, 90, 100, 0% (combined sexes).


Poor condition and respiratory distress was seen up to and
including 1 week post-exposure in surviving animals, but
clinical conditions of survivors had largely returned to
normal by day 14. Decedents generally died 1-2 days post-
exposure.
Gross pathology:
Effects on organs:
Dark red lungs were seen in all animals at the higher dose
levels (5.39, 3.22, 2.25 mg/l), considered to be treatment-
related rather than post-mortem change. They were also seen
in 3 males and 1 female exposed to 1.6 mg/l, but lungs in
the 1 mg/l group were comparable to those of controls.
Isolated changes did not appear to be dose-related, but
scattered skin lesions did show a relationship to dose.
Microscopic examination of the lungs showed acute
respiratory damage in those animals dying in the early
stages of the study, within 2 days of exposure,
characterised by pulmonary congestion and perivascular
oedema, also alveolar oedema and damage to alveolar walls.
In animals surviving to termination lung damage was
characterised by mild chronic inflammatory change which was
slight in degree in the animals exposed to 1 mg/l.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study on the analogous substance, Renewable Diesel is predicted to be classified as harmful via inhalation route of exposure.