Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979/11/14-1979/11/16
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is non-GLP and deviates from current guidelines. Study conducted on a read-across material

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: 49CFR173.343
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
1 h exposure and only male rats used. No detail about how the test substance was introduced into the air flow.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
EC 272-723-1
IUPAC Name:
EC 272-723-1
Details on test material:
Test material is described as amber liquid diluted 50% w/v in Mazola oil

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
Young adult, apparently in good health, male rats were supplied by Ace Animals and equilibrated in the laboratory for about one week. The rats were housed 5/cage in wire mesh cages in a temperature controlled room kept clean in accordance with AAALAC standards. Animals had free access to water and fresh Purina Rat Chow except during dosing.

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
other: maize oil
Details on inhalation exposure:
Rats were placed in individual cages, in a 435 litre stainless steel chamber with continuous air flow. The material was introduced into the air flow over the exposure period. The method of introducing the test material to the air flow is not described. The nominal concentration was 2 mg/L. The total volume of air was 2175 L/min. The amount of material delivered was 522 ml.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
1 h
Concentrations:
Nominal concentration = 2 mg/L
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
The animals were observed frequently during dosing, 3-4 h post dosing and daily for 2 days. Mortality and signs of pharmacological and toxicological effects were recorded. Body weights were recorded pre-test and terminally. At 2 days the survivors were sacrificed. Necropsies were performed in all rats and abnormal findings were noted.
Statistics:
No data.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC50
Effect level:
> 2 mg/L air (nominal)
Exp. duration:
1 h
Mortality:
All animals survived this test.
Clinical signs:
other: Clinical signs included lethargy, piloerection, chromorhinorrhea, tachypnea, and ptosis.
Body weight:
All animals lost weight.
Gross pathology:
Necropsy observations included lung and gastrointestinal abnormalities.
Other findings:
None reported.

Applicant's summary and conclusion

Interpretation of results:
other: Not classifiable
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the conditions of this study, the test material produced an LC 50> 2 mg/l in male Wistar rats.
Executive summary:

In an acute inhalation toxicity study, male Wistar rats were exposed to the test substance at a nominal concentration of 2 mg/l under continuous air flow conditions for one hour. The LC50 is >2 mg/l. Sublethal effects of lethargy, piloerection, chromorhinorrhea, tachypnea and ptosis were noted in all animals. Based on the results of this study, the test substance would be unclassifiable in accordance with the classification system of GHS. When converted to a 4 h exposure, the LC50 is calculated greater than 0.5 mg/l and only eliminates Category 1 or 2 classification.This toxicity study is classified as acceptable and satisfies the guideline requirement for acute inhalation toxicity in rats.