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Acute Toxicity: inhalation

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acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
Not relevant
GLP compliance:
Test type:
standard acute method
Limit test:

Test material

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

Details on test animals or test system and environmental conditions:
- 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

- 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
other: unchanged (no vehicle)
Details on inhalation exposure:
- 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.)

- 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

- 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:
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
6.6 mg/L (nominal concentration)
5.4 mg/L (1820 ppm, mean airborne concentration, measured)
No. of animals per sex per dose:
Control animals:
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.
No information provided.

Results and discussion

Preliminary study:
Not relevant
Effect levels
Dose descriptor:
Effect level:
> 5.46 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Clinical signs:
other: 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
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
Migrated information Criteria used for interpretation of results: EU
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.