Potassium dimethyl 5-sulphonatoisophthalate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

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)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Potassium dimethyl 5-sulphonatoisophthalate

EC Number:

233-915-0

EC Name:

Potassium dimethyl 5-sulphonatoisophthalate

Cas Number:

10433-41-7

Molecular formula:

C10H10O7S.K

IUPAC Name:

potassium 3,5-bis(methoxycarbonyl)benzene-1-sulfonate

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot number of test material: manufacturer, 60320
- Purity: 97.8 %

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (permissible range: 10° to 30°C, actual value: 17.4° to 22.7°C), in a tightly closed container in a dark place.
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage:
- Stability: The sponsor confirmed stability of the lest substance with KBr tablet method for infrared absorption spectrometry (IR spectrometry) before the first administration and after the final administration. As a result, the test substance used in this study was confirmed with no changes in its characteristics.

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Remarks:

SPF

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc. (Tsukuba breeding center)
- Females (if applicable) nulliparous and non-pregnant: yes
- Rationale for use of males: this strain is widely used in rodent toxicology studies, there is plenty of historical data, and a !arge number of animals are available.
- Age at study initiation: 8 weeks old
- Microbiological status: SPF


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.1 - 23.5
- Humidity (%): 46.2 - 60.2
- Air changes (per hr): 6 to 20 times/hr, all fresh filtered air
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5 w/v% CMC-Na solution

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2x3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before dosing, 10 and 30 minutes, 1, 3, and 6 hours after dosing (6 times in total) on the day ofthe first administration, and before dosing, 10 and 30 minutes, 2, 3, and 6 hours after dosing (6 times in total) on the day of the second administration.
- Necropsy of survivors performed: yes
- Clinical signs including body weight: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths were noted.

Clinical signs:

other: Diarrhea was observed transiently on the administration day. It was observed in all animals of the first adminsitration group and in 1 animal of the second administration group until 6 hours after dosing. This abnormal sign tended to recover and disappear

Gross pathology:

No abnmmalities in necropsy findings were noted in any animals of either the first or second administration.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

This study was conducted to assess the acute oral toxicity of IS-K, when administered via oral gavage to female Crl:CD(SD) rats aged 8 weeks according to the OECD 423. A single dose level of 2000 mg/kg was employed for the first and second administrations.
As a result, no deaths or abnormalities were found in the clinical observation, body weight gain, or necropsy.
Therefore, the approximate LD50 of IS-K under the conditions of this study was estimated to be above 2000 mg/kg, and classified in Category 5 (>2000-5000 mg/kg b.w.) of the GHS and no classification under CLP.