Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: BASF-Test: Test was performed in principle as described in OECD Guideline 403.
The test demonstrates the toxicity of an atmosphere saturated with vapours of the volatile components of a test substance at the temperature chosen for vapour generation (20 °C). 3 rats per sex were exposed to the vapours, generated by bubbling 200l/h air through a substance column of about 5 cm above a fritted glassdisc in a glass cylinder. After 30 minutes this column was replaced by a new column filled with fresh test substance which was used unil the end of the exposure time. The total exposure time was 7h. The documentation of clinical signs was performed over a period of 14 days after exposure with the test substance.
GLP compliance:
no
Test type:
other: Inhalation hazard test
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Golpanol PAP / 2-Propyn-1-ol, compd. with methyloxirane
- Physical state: liquid
- Analytical purity: approx. 50%
- Impurities (identity and concentrations): < 1% Propargylalcohol, approx. 35% water, approx. 7% Propylenglycol, aprox. 7% higher alcoxylated products

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: male (mean): 273g, female (mean): 217g
- Fasting period before study: no
- Housing: 3 rats per cage
- Diet (e.g. ad libitum): ad libitum except of the time of exposure
- Water (e.g. ad libitum): ad libitum except of the time of exposure
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Air changes (per hr): fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12 hours / 12 hours

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged, no vehicle
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION

- Source and rate of air: compressed air, 200 liter / hour
- Treatment of exhaust air: disposal
- Temperaturein air chamber: 19 - 25°C


Analytical verification of test atmosphere concentrations:
no
Remarks:
mean concentration estimated by reweighing
Duration of exposure:
7 h
Concentrations:
mean concentration of test substance during 7 hours of exposure: 5.1 mg/l, estimated by reweighing
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, pathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: Inhalation hazard test
Exp. duration:
7 h
Remarks on result:
other: no mortality occured when rats were exposed for 7 hours to the saturated vapor of the test material
Mortality:
no mortality was observed
Clinical signs:
during exposure: mopping of the snout, red nose discharge, delayed pain reflex
after exposure: bloody nose discharge
Body weight:
at beginning of the test: male (mean): 273, female (mean): 217
Gross pathology:
no pathological findings

Any other information on results incl. tables

No mortalities after 7-hour exposure to an atmosphere enriched with the test material.

Applicant's summary and conclusion

Executive summary:
No mortalities after 7-hour exposure to an atmosphere enriched with the test material.