Ethanesulphonic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006 - 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Ethanesulphonic acid

EC Number:

209-843-0

EC Name:

Ethanesulphonic acid

Cas Number:

594-45-6

Molecular formula:

C2H6O3S

IUPAC Name:

ethanesulfonic acid

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Crl:WI(Han), SPF quality

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

50 mg/kg:
300 mg/kg
2000 mg/kg

No. of animals per sex per dose:

50 mg/kg: 3 females
300 mg/kg: 3 females / 3 males
2000 mg/kg: 3 females

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 300 - <= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

In rats, no mortality was observed subsequent to a single oral administration of 50 mg/kg
in females or 300 mg/kg in rats of both genders.
Following administration of 2000 mg/kg to female rats, No. 352 was found dead on Day 1
(6.0 h post administration), and No. 351 in the morning of Day 2. Female No. 353 survived
the entire observation period.

Clinical signs:

50 mg/kg (females only)
No clinical signs were recorded.
300 mg/kg (males and females)
Clinical signs were observed in males on Day 1 only and included piloerection (0.5 h to
8.0 h post administration) and reduced motor activity (0.5 h to 2.0 h post administration).
All males returned to normal on Day 2 and no further clinical signs were observed
throughout the entire observation period.
2000 mg/kg (females only)
Clinical signs were observed throughout Day 1 in all animals and included piloerection
and reduced motor activity. In addition, prone position and decreased breathing rate
(0.25 h to 0.5 h post administration) was recorded temporarily on Day 1. The latter
decedent No. 351 appeared cold to the touch (8.0 h to 10.5 h). The surviving female
No. 353 returned to normal in the morning of Day 2 and no further clinical signs were
observed throughout the entire observation period

Body weight:

At 50 mg/kg and at 300 mg/kg, no influence on body weight development was observed.
Compared to rats administered the latter doses, a reduced body weight was recorded on
Day 2 in rat No. 353, the single out of three females surviving administration of
2000 mg/kg. This difference was no longer obvious on Day 8 and Day 15.

Gross pathology:

No necropsy findings were recorded subsequent to a single oral administration of
50 mg/kg or 300 mg/kg.
Necropsy findings in No. 351 and No. 352, the two premature decedents at 2000 mg/kg,
included stasis of liver, spleen and kidneys, an altered content of the abdomen, as well as
alterations in the stomach and the intestine.
No necropsy findings were recorded for No. 353, the single female surviving the entire
observation period following administration of the latter dose.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the conditions of the present study, no mortality was seen in rats subsequent to a
single oral administration of ethane sulfonic acid doses of 50 mg/kg and 300 mg/kg,
respectively. Following an administration of 2000 mg/kg, two out of three females died.
Thus, at the given purity of 70%, the approximate lethal dose (ALD) for ethane sulfonic
acid is between 300 mg/kg and 2000 mg/kg for
male and female rats