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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

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)
Principles of method if other than guideline:
Not relevant
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): C-243
- Molecular formula (if other than submission substance): Not documented
- Molecular weight (if other than submission substance): Not documented
- Smiles notation (if other than submission substance): Not documented
- InChl (if other than submission substance): Not documented
- Structural formula attached as image file (if other than submission substance): see Fig. Not documented
- Substance type: Not documented
- Physical state: water-white liquid.
- Analytical purity: Not documented
- Impurities (identity and concentrations): Not documented
- Composition of test material, percentage of components: Not documented
- Isomers composition: Not documented
- Purity test date: Not documented
- Lot/batch No.: Not documented
- Expiration date of the lot/batch: July 1983
- Radiochemical purity (if radiolabelling): Not documented
- Specific activity (if radiolabelling): Not documented
- Locations of the label (if radiolabelling): Not documented
- Expiration date of radiochemical substance (if radiolabelling): Not documented
- Stability under test conditions: Not documented
- Storage condition of test material: Not documented
- Other: Not documented

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, Massachusetts
- Age at study initiation: Not documented
- Weight at study initiation: 214-248 g (males) and 208-220g (females)
- Fasting period before study: Not documented
- Housing: Housed individually in elevated, stainless steel and wire mesh cages
- Diet (e.g. ad libitum): Pelleted food (Purina Rodent Laboratory Chow - 5001) ad libitum during exposure period.
- Water (e.g. ad libitum): City tap water (Elizabethtown Water Co.) ad libitum.
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not documented
- Humidity (%): Not documented
- Air changes (per hr): Not documented
- Photoperiod (hrs dark / hrs light): Not documented

IN-LIFE DATES: From: To: Not documented

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Plexiglas chamber, whole body exposure
- Exposure chamber volume: 100 L
- Method of holding animals in test chamber: in groups
- Rate of air: 20 L/min
- Method of conditioning air: 23°C thermostat (water bath)
- System of generating particulates/aerosols: Dosing of the TS into a round-bottom flask at an approximate rate of 10 mL/h
and evaporation by a difned air flow
- Method of particle size determination: Royco Model 218 Portable Particle Monitor (samples taken during the first 2 hours of exposure)
- Treatment of exhaust air: no data
- Temperature, humidity: 72°F, 53% (rel.)


TEST ATMOSPHERE
- Brief description of analytical method used: gravimetrically (mass difference of the TS divided by the total air volume = nominal concentration)
- Samples taken from breathing zone: not documented


VEHICLE
- not relevant, air


TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: no aerosols detected


CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: no information provided
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Samples during 2 h of exposure (in total 9, see Table 1) were analysed by using a Miran IR spectrometer.
Duration of exposure:
4 h
Concentrations:
6.6 mg/L (nominal concentration)
5.4 mg/L (1820 ppm, mean airborne concentration, measured)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for abnormal signs before exposure, every fifteen minutes during the first hour of exposure, hourly through exposure termination, upon removal from the chamber, for four hours post-exposure and daily thereafter for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: body weight:individual body weights for all rats were recorded on Day 0 (prior to exposure) and on Days 1, 2, 4, 7 and 14.
Statistics:
No information provided.

Results and discussion

Preliminary study:
Not relevant
Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.46 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
no
Clinical signs:
Most rats exhibited closed eyes and some exhibited red nasal discharge and chromodacryorrhea during the exposure period which commenced after 15 minutes of exposure. After removal from the exposure chamber, all rats exhibited lacrimation and conjunctival swelling and most rats exhibited nasal discharge (both mucoid and red). These signs either had abated or decreased in frequency duriong the four hour post exposure period. Lacrimation was observed in some rats on up to 6 occasions during the 14 day observation period which was not considered to be exposure related. Other signs were seen transiently in isolated rats but were not considered to be associated with exposure to the test material.
Body weight:
Small, transient weight losswas seen in all rats, however, the body weights had recovered to pre-exposure values in most males by Day 2 and in most females by Day 7. Body weight increments in the second week were within the limits of normal expectation for both sexes.
Gross pathology:
no particular findings
Other findings:
No additional information

Any other information on results incl. tables

No mortality occurred. Most rats exhibited closed eyes and some exhibited red nasal discharge and chromodacryorrhea.

Although small, transient weight losses were seen in all rats, the body weights recovered to pre-exposure-values in most males by day 2 and in most females by day 7. No necropsy abnormalities were noted.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The inhalation LC50 is >5.4 mg/L
Executive summary:

In an inhalation screening test, 10 SD rats (5 m, 5 f) were exposed to a mean vapour concentration of 1820 ppm (5.4 mg/L) for 4 h (limit test). There was no mortality during exposure or the 14 -d post-exposure observation period. Clinical signs of respiratory and eye irritation were observed in most animals at the end of exposure. Most of these signs reversed within 2 h, but lacrimation persisted for up to 12 d. all animals lost body weight after exposure, males recovered in 2 d, and females in 7 d. No gross pathology was observed at the end of the 14-d observation period. The inhalation LC50 is >5.4 mg/L.