Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05-Sep-1988 - 28-Feb-1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Mercaptoacetic acid, monoester with propane-1,2,3-triol
EC Number:
250-264-8
EC Name:
Mercaptoacetic acid, monoester with propane-1,2,3-triol
Cas Number:
30618-84-9
Molecular formula:
C5H10O4S
IUPAC Name:
1,3-dihydroxypropan-2-yl 2-sulfanylacetate 2,3-dihydroxypropyl 2-sulfanylacetate
Test material form:
solid - liquid: suspension
Details on test material:
- Name of test material (as cited in study report): Glycerol monothioglycolate
- Analytical purity: 75 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Iffa-Credo, Les Oncins, 69210 L'Arbresle, France
- Age at study initiation: young adults, 5 to 7 weeks old
- Weight at study initiation: males: 177-218 g, females: 150 - 186 g
- Fasting period before study: 15 - 18 h
- Housing: By sex and in groups of 5 in polycarbonate cages of type MI of internal dimensions 365 x 225 x 180 mm
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 10 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
0.104, 0.122, 0.141, 0.164, 0.192 mL/kg bw administration of test article as supplied
Doses:
136, 160, 185, 210, 215, 252 mg/kg bw
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: Mortality and abnormal clinical signs were noted 15 minutes after administration of the test article, then 1, 2 and 4 hours later and then daily during the 14 day study period. The animals were weighed on Day -1, Day 1 (immediately before administration of the test article), Days 8 and 15.
- Necropsy of survivors performed: yes
Statistics:
Bliss's method and Lichfield & Wilcoxon's method used for LD50 calculation

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
172 mg/kg bw
Based on:
test mat.
95% CL:
153 - 193
Remarks on result:
other: by Bliss' method
Sex:
male/female
Dose descriptor:
LD50
Effect level:
181 mg/kg bw
Based on:
test mat.
95% CL:
162 - 201
Remarks on result:
other: by Lichfield & Wilcoxon's method
Mortality:
see table 1
Clinical signs:
- 136 mg/kg bw: Subdued behaviour was recorded in all the animals at 4 hours after treatment and prostration in one out of them on Day 2.
- 160 mg/kg bw: Subdued behaviour was recorded in all the animals at 2 hours after treatment and prostration at 4 hours.
- 185 mg/kg bw: Subdued behaviour was recorded in all the animals at 2 hours after treatment and lethargy or subdued behaviour in the surviving ones at 4 hours
- 210 mg/kg bw: Subdued behaviour was recorded in all the animals at 4 hours after treatment
- 215 and 252 mg/kg bw: Subdued behaviour was recorded in all the animals at 2 hours after treatment and lethargy or prostration in the surviving ones at 4 hours
Body weight:
Body weights at 136, 160 and 185 mg/kg were not influenced by treatment. The increase of weight of the males treated at the dose level of 210 mg/kg seemed to be lower than those of the rats treated and housed under the same conditions. The mortality rate at 215 and 252 mg/kg did not allow analysis of their body weight changes.
Gross pathology:
Animals died during the study showed congested areas in the lungs and a pale aspect of the liver (at dose level of 210 mg/kg). No macroscopically noticeable abnormalities were noted when necropsying the rats killed at the end of the study (day 15).

Any other information on results incl. tables

LD50 calculated by Bliss' method was 172 mg/kg and 181 mg/kg calculated by Lichfield and Wilcoxon's method.

Table 1: Acute oral toxicity of GMT 75

Dose level [mg/kg]

Sex

# dead/ # treated

Total Mortality [%]

136

m

0/5

0

f

0/5

160

m

2/5

60

f

4/5

185

m

2/5

60

f

4/5

210

m

2/5

50

f

3/5

215

m

4/5

80

f

4/5

252

m

4/5

90

f

5/5

 

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The LD50 for GMT was 172 mg/kg calculated by Bliss' method and 181 mg/kg calculated by Lichfield and Wilcoxon's method.