Registration Dossier

Administrative data

Endpoint:
specific investigations: other studies
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Full GLP report guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: ASTM method E981-84, Standard Method for Estimating Sensory Irritation of Airborne Chemicals, 1984
GLP compliance:
yes
Type of method:
in vivo

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Mondur TD 80

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male

Administration / exposure

Route of administration:
inhalation: vapour
Vehicle:
unchanged (no vehicle)
Details on exposure:
The test substance was generated as a vapor in a glass bubbler, immersed in a water bath at 25 degree C, and concentrations achieved by varying the rate of airflow.
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
Concentrations of Mondur TD-80 in the exposure chamber were determined at 0.5, 1.5, and 2.5 hours of exposure.
Duration of treatment / exposure:
3h
Doses / concentrations
Remarks:
Doses / Concentrations:
0.10 to 1.45 ppm
Basis:
analytical conc.
No. of animals per sex per dose:
4
Details on study design:
Statistics
The RD 50 value with 95% confidence limits were calculated by probit analysis using computer programs of SAS (SAS Institute Inc. Cary, North Carolina, US)

Results and discussion

Details on results:
Effect levels
Sex male
Endpoint other: RD50
Effect level 2.12 ppm
95% CL 1.61 — 3.4
Exp. duration 3 h
Remarks

Any other information on results incl. tables

Remarks on results including tables and figures

95% confidence interval = 1.61 - 3.40 ppm

mean analytical

concentration

decrease in respiratory rate

(% of control)

0.10

0

0.36

7

0.84

24

1.45

35

Applicant's summary and conclusion