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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:
key study
Study period:
February 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study. No GLP compliance is claimed, however, the final report includes an audit and quality assurance inspections. The test chamber concentration was not measured analytically.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
not applicable
GLP compliance:
no
Remarks:
The final report includes an audit and quality assurance inspections.
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: King Animal Labs, Oregon, Wisconsin
- Age at study initiation: not reported
- Weight at study initiation: males (mean) 271g; females (mean) 197g
- Fasting period before study: no
- Housing: housed in groups of 3 per sex for one week prior to study initiation; for a further 2 weeks prior to study initiation the animals were individually in suspended, stainless steel cages (25 x 17.8 x 17.8 cm). During inhalation exposure the rats were individually housed in perforated metal exposure cages measuring 25 x 8 x 8 cm. Following exposure the rats were transferred into stainless steel cages measuring 18.4 x 16.5 x 15.9 cm
- Diet: Purina Rodent Chow 5001 (Ralston Purina Co.) ad libitum
- Water: ad libitum
- Acclimation period: 3 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 40
- Photoperiod (hrs dark / hrs light): 12 /12

IN-LIFE DATES:
From 3 February 1981 to 17 February 1981

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
The generating system consisted of a 2000 mL, 3-neck flask (Ace Glass #6947-40) containing 1L of the test article. A mineral bath (Model 220, National Appliance Co., Portland, Oregon) was heated to the desired temperature prior to immersing the test article flask. Air entered the flask via a gas dispersion tube (Ace Glass #7202-16, pore size 25-50 µm). The middle neck of the flask contained a thermometer for measuring the temperature of the test article. Air bubbles carried the test article vapour upward via a 105° elbow (Ace Glass #5075-10) into the exposure chamber. The entire air flow of the chamber passed through the generator flask.
The 50 x 24.3 x 30 cm (37 L) chamber was made of Plexiglas(R). The front of the chamber was removable to facilitate loading and unloading of animals. The test article vapour entered a port at the top of one side of the chamber and exited at the bottom of the opposite side. The vapour was vented into a California type fume hood followed by a filter system.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
4 h
Concentrations:
2.75 mg/L
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily and more often on the day of dosing
- Necropsy of survivors performed: yes
- Other examinations performed: body weights and necropsies
Statistics:
No statistical methods are reported.

Results and discussion

Preliminary study:
Not applicable.
Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2.75 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No mortalities during the study.
Clinical signs:
other: A clear nasal discharge, red encrustation around nose and eyes, and salivation were observed in four rats following exposure. One male rat exhibited diarrhoea immediately following exposure and on the following day. All remaining rats appeared normal.
Body weight:
The mean initial body weights of the male and female rats were 271 g and 197 g, respectively.
Gross pathology:
At necropsy, seven rats appeared normal. Three rats had spongy lungs and/or brown foci through all lung lobes.
Other findings:
None reported.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The test report describes a valid guideline study, with auditation and quality assurance inspections of the final report. The acute inhalation median lethal concentration (LC50) was estimated to be > 2.75 mg/L. Thus, the test substance can be considered as not acutely toxic via the inhalative route.
Executive summary:

An acute inhalation study was conducted using a similar procedure to that described in the current OECD Guideline 403 (Findlay, 1981).

The test material (CAS No. 91648-65-6) was administered at 2.75 mg/L by inhalation for 4 h to five male and five female rats. The rats were observed for 14 days after test material administration. No mortalities occurred during the study. The following clinical signs were noted during the study: a clear nasal discharge, red encrustation around nose and eyes, and salivation were observed in four rats following exposure, one male rat exhibited diarrhoea immediately following exposure and on the following day. All remaining rats appeared normal. At necropsy, seven rats appeared normal. Three rats had spongy lungs and/or brown foci through all lung lobes. The acute inhalation median lethal concentration (LC50) was determined to be > 2.75 mg/L.