Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980-09-24 to 1980-10-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
1981-05-12
Deviations:
yes
Remarks:
information on strain of rats, equilibration period, and on time period of observations were missing; rats were not weighed weekly
Principles of method if other than guideline:
It has to be mentioned that no OECD guideline was available at the time of conduct.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS - albino rats
- Housing: the animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3.
- Weight at study initiation: average initial body weight: 210 g (males) and 205 g (females)

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
other: mineral spirits and clean air
Details on inhalation exposure:
PREPARATION OF TEST MATERIAL
The material was used as a 50% w/v suspension in mineral spirits

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: the animals were exposed to the test material inside a 260 liter plexiglass exposure chamber.

- System of generating particulates/aerosols: the material was administered as an aerosol which was generated by a six jet Collision nebulizer (BGI Incorporated, Waltham, Mass.). The air was passed through a desicant prior to being passed through the test material. The rate of flow through the chamber was 20 liters per minute (except during particle size measurement) at a temperature of 72°F (22.2°C).

- Method of particle size determination: particle size of the aerosol was determined using an Andersen Sampler cascade impactor. The Andersen Sampler was run for 5 minutes midway through the exposure. During sampling, air from the breathing zone of the animals was drawn through the cascade impactor at the rate of 1 cubic foot per minute (28.3 liters per minute).
The amount of aerosol impacting on each plate of the Andersen Sampler was determined by differential weighing. From these values the mass median diameter of the aerosol was calculated to be 0.54u and the concentration was calculated to be 0.42 mg/liter.

TEST ATMOSPHERE
The average concentration of the aerosol over the four hour exposure period was calculated to be 11.6 mg/liter by differential weighing of the flask from which the aerosol was generated.

Analytical verification of test atmosphere concentrations:
yes
Remarks:
please refer to "details on inhalation exposure" above
Duration of exposure:
4 h
Concentrations:
Actual concentration: 0.42 mg/liter (maximum concentration which could be attained)
Nominal concentration: 11.6 mg/liter
No. of animals per sex per dose:
5 males / 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Examinations performed: Signs of toxicity and mortalities (daily) were noted. The average initial body weight and the average final body weight were determined.
Statistics:
not stated

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 420 mg/m³ air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: the maximum concentration which could be attained
Mortality:
No mortality occurred during the study.
Clinical signs:
other: No untoward symptoms were observed during the four hour exposure period. Within 18 - 24 hours the animals appeared depressed and ruffled. They were essentially normal after 48 hours.
Body weight:
The average body weight of the rats increased during the study.
Gross pathology:
Gross pathological examination revealed nothing remarkable.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LC50 (male and female rats, 4h) > 0.42 mg/liter (analytical)
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as acute toxic via the inhalation route.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the inhalation route.