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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Non-GLP study; however, basic parameters are documented and study was conduced similar to OECD 403.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Principles of method if other than guideline:
This test was performed in principle as described in OECD Guideline 403.
Deviations: 3 rats per sex were exposed, two exposure times (8hours and 3 hours) instead of 4h, clinical signs was perfomred over 7 days
GLP compliance:
no
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Propargylglykol, Ethylenglykol-monopropargyl-ether
- Molecualr weight: 100.12 g/mol
- densitiy: 1.02-1.04 g/cm3
- Puritiy: 98%
- Physical state: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: average 168 g (8hours-study) and 185g (3hours-study)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Air changes (per hr): 200Ltr

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
Vapor was generated by bubbling 200l/h air through a substance column of about 5cm above a fritted glass disc.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Remarks on duration:
another timepoint was 3 hours of exposure
Concentrations:
1,33 mg/l
No. of animals per sex per dose:
3
Control animals:
yes
Details on study design:
Several groups of 3 rats per sex were exposed sequentially to the vapors,
generated by bubbling 200 1/h air through a substance column of about 5 cm above a
fritted glass disc in a glass cylinder for 3 and 8 hours.
Group-wise documentation of clinical signs was performed over a 7- day study period. Body weight of groups was determined before the start of the study and at the end of the Observation period in surviving animals.

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, gross pathology

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
1.33 mg/L air
Based on:
act. ingr.
Exp. duration:
8 h
Remarks on result:
other: Attention, increased exposure time (8h) instead of todays used 4h. See "Remarks on results"
Sex:
male/female
Dose descriptor:
LC50
Effect level:
ca. 1.34 mg/L air
Based on:
act. ingr.
Exp. duration:
3 h
Mortality:
No mortality occured in this study after 3hours of exposure.

Exposure of 8hours conducted to one dead animal after 24h, one dead animal after 48h and one dead animal after 72h, so that half of the animals were dead after 72hours.
Clinical signs:
other: 3h-Exposure: no effects 8h-Exposure: -strong mucosa irritation - nose, discharge, bloody - dyspnea
Gross pathology:
Heart: acute dilatation and accumulation of blood
Liver: yellow coloured
stomach: dilatation
lung: acute flatulence
Other findings:
8h exposure: 3 of 6 animals were dead within 3 days after exposure. Survivors showed no effects after 3 days and were killed at the end of this study after 7 days.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category II
Remarks:
Migrated information GHS Criteria used for interpretation of results: EU
Executive summary:

This test was performed in principle as described in OECD Guideline 403 without GLP compliance.

3 rats per sex were exposed sequentially to the vapor, generated by bubbling 200 1/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 3 hours and 8 hours. Documentation of clinical signs and mortality was performed over 7 days.

No mortality occured in this study after 3hours-exposure. Exposure of 8hours conducted to one dead animal after 24h, one dead animal after 48h and one dead animal after 72h, so that half of the animals were dead after 72hours.

The classification criteria for acute inhalation toxicity relate to a 4h experimental exposure period. After adjustment to a 4h-equivalent by Haber´s law (c^n*t=constant), an LC50 of 1,67 mg/l/4h could be calculated and therefore the test item should be classified as inhalation toxic category 2. (BASF, 1975)