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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:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
In the absence of analytical determination of the actual concentration and considering the large variation that could exist between nominal and analytical concentrations in inhalation studies with aerosols, the value of the LC0 is subject to cautions. In addition, data on aerosol particle size were not provided.

Data source

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

Materials and methods

Principles of method if other than guideline:
Animals were exposed for one hour to a liquid droplet aerosol of the experimental compound.
GLP compliance:
no
Test type:
fixed concentration procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
aerosol dispenser: not specified
Remarks:
migrated information: aerosol
Details on test material:
- Name of test material (as cited in study report): Ammonium Thioglycolate 60%
- Physical state: clear, colourless liquid
- Analytical purity: no data
- Lot/batch No.: BA 95-728
- Other: Source: Evans Chemetics, Darin, CT
(It is supposed that the 60% refers to the thioglycolic acid content equivalent to 71% ammonium thioglycolate)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Blue Spruce Farms, Altamont, NY
- Weight at study initiation: 289 +/- 14 g (males) and 205 +/-5 g (females)
- Housing: animals were housed by sex in groups of five.
- Diet (e.g. ad libitum): Agway gruond diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 7 days

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: acrylic exposure chamber
- Exposure chamber volume: 125 L
- Source and rate of air: compressed air passed through the atomizer at 20 L/min
- System of generating particulates/aerosols: Atomizer (Spraying Systems No. 1/4J with a #1650 ss fluid nozzle and a #64 ss air nozzle)
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
1 h
Concentrations:
2.75 mg/L
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: Daily observations for signs of pharmacotoxic effects. Body weights were recorded prior to exposure and at 7 and 14 days post-exposure.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
> 2.75 mg/L air (nominal)
Exp. duration:
1 h

Any other information on results incl. tables

The nominal concentration was 2.75 mg/L (expressed as mg of the supposed  71% solution of ammonium thioglycolate). This 

value is equivalent to 1.95  mg/l of pure ammonium thioglycolate or 1.65 mg/l of thioglycolic acid.
During exposure, some evidence of laboured breathing was observed.  Post-exposure, a few rats exhibited traces of lacrimation

or nasal  discharge;  however, these signs disappeared within about 24 hours. The  rats appeared to be normal throughout the

remainder of the observation period.
None of the rats died as a consequence of the exposure. Body weight gains  were normal for all rats during the first week post-exposure. However, by the end of the second post-exposure week body weight gains became erratic.

              Body Weight
Animal  Initial 7 days 14 days
Male
1 282 323 330
2 292 362 360
3 284 372 365
4 272 335 324
5 314 418 403
Average 288,8 362 356,4
Male
1 214 257 243
2 202 254 232
3 200 226 221
4 202 209 215
5 206 225 231
Average 204,8 234,2 228,4


Necropsy observation of the lungs of 9 of 10 rats were characterized as  being 'grayish' or marked with scattered red or gray 

foci on one or more  lobes.  In addition, the cervical lymph nodes of 3 of 10 rats were marked  by a fews scattered red spots. 

The one hour LC0 is > 2.75 mg/L based on nominal concentration.

Applicant's summary and conclusion