Ethanesulfonic acid, 1-(dimethylamino)-2-hydroxy-, sodium salt (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 19 - February 9, 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

other: Single oral (gavage) dose

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

sodium 2-(dimethylamino)-1-hydroxyethane-1-sulfonate

EC Number:

929-207-2

Cas Number:

1172126-47-4

Molecular formula:

C4 H11 Cl N Na O4 S

IUPAC Name:

sodium 2-(dimethylamino)-1-hydroxyethane-1-sulfonate

Test animals

Species:

rat

Strain:

other: WI(Han)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
Species, number of animals: 9 rats, 3 males (M) and 6 females (F)
Strain: Crl:WI(Han), SPF quality
Supplier: Charles River Laboratories, Sulzfeld, Germany
Age (Day 1): approximately 8 weeks
Body weight range (Day 1): males 231-236 g, females 165-167 g

HOUSING CONDITIONS:
Housing and target ranges of the climate conditions were as follows:
Room number: 35, building N81
Temperature: 22 ± 2°C
Relative humidity: 45%-75%
Light/darkness cycle: 12/12 hours
Illumination period: 06:00 h-18:00 h
Average illumination: approximately 60 lx (depending on the cage position; during
work in the room the intensity is raised to approximately
450 lx)
Air change: minimum of 10 air changes per hour

FOOD & DRINKING WATER:
The animals were offered pelleted dry food (Kliba No. 3438.0.25, Provimi Kliba SA,
Kaiseraugst, Switzerland). The lot number of the food is recorded in the raw data. The food is
analyzed regularly for major nutritive components and significant contaminants by the
manufacturer. It was available ad libitum, but was withdrawn in the afternoon of Day -1 (at
about 16:00 h) over night. Immediately post administration, free access to food was allowed
again.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5% aqueous hydroxyethylcellulose (Natrosol® 250 HX)

Details on oral exposure:

PD 159 NA was suspended in 0.5% aqueous hydroxyethylcellulose (Natrosol® 250 HX) and
administered by oral gavage (20 mL/kg) at single doses of 200 mg/kg (females only) and
2000 mg/kg (males and females), respectively, to groups of Crl:WI(Han) rats, which were
about 8 weeks old.

Doses:

200 mg/kg and 2000 mg/kg

No. of animals per sex per dose:

3 females per 200 mg/kg bw
3 males per 2000 mg/kg bw
3 females per 2000 mg/kg bw

Control animals:

no

Details on study design:

Prior to administration, the rats were kept over night without food, but with free access to
drinking water. Free access to food was allowed again immediately subsequent to
administration.

In the morning of the day, single oral administration of PD 159 NA suspended in Natrosol® 250 HX was performed by gavage per group.

The administration volume was 20 mL/kg in each group.

group 1: 3 females per 200 mg/kg bw
group 2: 3 males per 2000 mg/kg bw
group 3: 3 females per 2000 mg/kg bw

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

other: ALD

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed in rats subsequent to a single oral administration of 200 mg/kg
and 2000 mg/kg, respectively.

Clinical signs:

other: 200 mg/kg (females) Throughout the entire observation period, no clinical signs were noted in any rat. 2000 mg/kg (males and females) During the entire observation period, no clinical signs were noted in males. In females, piloerection was the only clinic

Gross pathology:

At necropsy, no findings were noted in females subsequent to administration of 200 mg/kg or
in male and female rats administered 2000 mg/kg.

Applicant's summary and conclusion

Interpretation of results:

other: not classified acc. CLP

Conclusions:

Under the conditions of the present study, no mortality was seen in rats subsequent to oral
administration of PD 159 NA at doses of 200 mg/kg and 2000 mg/kg, respectively.
Thus, the approximate lethal dose (ALD) for PD 159 NA, an intermediate of
BIBW 2992 MA2, is above 2000 mg/kg.