Mercaptoacetic acid, monoester with propane-1,2,3-triol

Acute Toxicity: oral

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

Test material information

Constituent 1

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:

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 levels

Effect levels 1

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

Effect levels 2

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:

other: - 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 hou

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.