Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: secondary literature

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Letter to US EP cited in BUA 37
Author:
Eastman Kodak Co
Year:
1984
Bibliographic source:
Doc ID 86-910000057 cited in BUA 37
Reference Type:
review article or handbook
Title:
Triethylphosphat BUA Stoffbericht 37 (Maerz 1989)
Author:
Anon
Year:
1989
Bibliographic source:
Beratergremium für umweltrelevante Altstoffe (BUA) d. Ges. Dt. Chemiker, Weinheim, Basel (Schweiz), Cambridge, New York, NY: VCH 1989 (Bua Stoffbericht 37)

Materials and methods

Principles of method if other than guideline:
Three groups of 5 male rats were exposed by inhalation to aerosol concentrations of 0, 366, or 1786 mg/m³ of the test substance 5 h/day, 5 days/week for a total of 12 exposures. About 35% of the test atmosphere was respirable.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
not specified
Vehicle:
other: no data
Remarks on MMAD:
MMAD / GSD: no data
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
12 weeks
Frequency of treatment:
5 h/day, 5 days per week
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 366, or 1786 mg/m³
Basis:
no data
No. of animals per sex per dose:
5
Control animals:
yes

Results and discussion

Effect levels

Dose descriptor:
NOAEC
Effect level:
366 mg/m³ air
Sex:
male

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Abnormal clinical signs in the high-exposure group included lethargy, decreased aural response, unsteady gait, and porphyrin nasal discharges which resolved prior to subsequent exposures. No abnormal clinical signs were seen in the low-dose group. Weight gain, hematology, clinical chemistry, and gross and histopathology were unremarkable at both dose levels. Slightly increased (17 -19%) absolute and relative (to body weight) liver weights were noted in the high-exposure group, but these were not considered toxicologically significant in the absence of histopathology or clinical chemistry changes.

Applicant's summary and conclusion

Executive summary:

Three groups of 5 male rats were exposed by inhalation to aerosol concentrations of 0, 366, or 1786 mg/m³ of the test substance 5 h/day, 5 days/week for a total of 12 exposures. About 35% of the test atmosphere was respirable.

A NOAEL = 366 mg/m³ was observed.