Sodium dimethyl 5-sulphonatoisophthalate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-05-22 to 2012-06-06

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:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium dimethyl 5-sulphonatoisophthalate

EC Number:

223-578-8

EC Name:

Sodium dimethyl 5-sulphonatoisophthalate

Cas Number:

3965-55-7

Molecular formula:

C10H10O7S.Na

IUPAC Name:

sodium 3,5-bis(methoxycarbonyl)benzenesulfonate

Test material form:

other: solid

Details on test material:

Name: Sodium dimethyl 5-sulphonatoisophthalate (SIM-Ester)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90.
- Age at study initiation: Young adult rats, females were nulliparous and non-pregnant
- Weight at study initiation: 269-289 g (male); 255-267 g (female)
- Housing: during acclimatisation: 3 animals/sex/cage; during the study: animals were housed individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 19 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 8-12 air exchanges/hour by central air-condition system.
- Photoperiod: Artificial light, from 6 am. to 6 pm.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: back of animals
- % coverage: least 10 % of the total body surface area
- Type of wrap if used: semi-occlusive plastic wrap

REMOVAL OF TEST SUBSTANCE
- At the end of the exposure period, residual test item was removed, using body temperature water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- For solids, paste formed: The solid test item was moistened sufficiently with water

Duration of exposure:

24 hours

Doses:

2000 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:
MORTALITY
twice daily
CLINICAL OBSERVATION
Animals were observed individually 1 h and 5 h after dosing, and once each day for 14 days thereafter.
BODY WEIGHT
On day 0 (shortly before the treatment), on day 7 and on day 15 (with a precision of 1 g in main study).
- Pathology: All animals were subjected to gross pathology.

Statistics:

No statistics were performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality

Clinical signs:

other: No behavioural changes or general systemic toxic signs were noted during the study. Similarly, no any local symptoms (dermal irritation) were observed on the treated skin of animals as redness and oedema.

Gross pathology:

No macroscopic alterations due to the systemic toxic effects of the test item were found.

Applicant's summary and conclusion

Conclusions:

The obtained acute dermal LD50 value was greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats.

Executive summary:

In an acute dermal toxicity study ( Toxi-Coop Zrt., 2012, OECD 402, GLP compliance) a single group of male and female animals (n=5 animals/sex) was exposed to Sodium dimethyl 5-sulphonatoisophthalate (SIM-Ester) at 2000 mg/kg bw by dermal route. The test item was applied in its original form and left in contact with the skin for 24 hours, followed by a 14-day observation period. No mortality occurred during the study. Neither male nor female animals treated at 2000 mg/kg bw showed behavioural changes and no systemic toxic signs were noted during the study. The test item did not cause dermal irritation symptoms as erythema, oedema or other signs. One female animal did not gain weight during the study period. As the body weight development of all other animals was not impaired, a test item related effect is unlikely. No macroscopic alterations of organs and tissues referred to the systemic toxic effect of the test item were seen during the necropsy. In conclusion, in this acute dermal toxicity study with SIM-Ester, the obtained acute dermal LD50 value was greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats.