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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1974

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Standard acute method with one single administration by gavage per animal and per dose level.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhexyl mercaptoacetate
EC Number:
231-626-4
EC Name:
2-ethylhexyl mercaptoacetate
Cas Number:
7659-86-1
Molecular formula:
C10H20O2S
IUPAC Name:
2-ethylhexyl sulfanylacetate
Details on test material:
- Name of test material (as cited in study report): Thioglykolsäure-2-äthylhexylester
- Analytical purity: technical quality
- Impurities (identity and concentrations): no relevant impurity


Test animals

Species:
rat
Strain:
other: conventional random strain from laboratory
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: conventional random strain from "Staatlichen Zentralstelle für Versuchstierzucht und -versorgung, Berlin, Lichtenberg."
- Age at study initiation: no data
- Weight at study initiation: between 150 and 180 g
- Fasting period before study: 18 h before study
- Housing:groups of 10 rats
- Diet (e.g. ad libitum): pellets of standard food of K type
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
peanut oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 1/10 (v/v)

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: litterature data
Doses:
No data
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: every week
- Necropsy of survivors performed: yes
- Other examinations performed: body weight increase, necropsy
Statistics:
Calculation of LD50: Lichtfield and Wilcoxon for the days of application, and Deichmann and Leblanc until the end of deaths due to test substance.

Results and discussion

Preliminary study:
No preliminary study
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
303 mg/kg bw
95% CL:
> 259 - < 355
Sex:
female
Dose descriptor:
LD50
Effect level:
334 mg/kg bw
95% CL:
> 250 - < 446
Mortality:
No details available
Clinical signs:
No data.
Body weight:
No body weight increase reduction.
Gross pathology:
At necropsy there were no pathological section findings.
Other findings:
Additionnal single sublethal doses were tested: 80 mg/kg bw.
At this dose, after 20 hours, no significant damages of the liver or kidneys were observed (relative and absolute organ weight of liver and kidneys, Hexobarbital sleeping time, serum creatinine rate, activity of Serum LAP and Serum aldolase, hemoglobine rate, urine volume, albumine rate in urine, macrosopic observation . At necropsy there were no pathological section findings and body weights were not adversely affected.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The resulting LD50 was 303 mg/kg for male and 334 mg/kg for female. According to CLP criteria, 2-EHTG should be classified as Acute Tox 3 - H302: Harmful if swallowed.
Executive summary:

In an acute oral rat toxicity studywith EHTG in peanut oil, the LD50 was 303 mg/kg bw (males) and 334 mg/kg bw (females). There were 70 animals assigned to this study. There were no adverse effects seen in any of the rats during the macroscopic examination at necropsy and body weights were not adversely affected. A single sublethal doses of 80 mg EHTG/kg bw produced no significant damage of the liver or kidneys in either sex.