Methanesulfonic acid, 1,1'-(1,6-hexanediyldiimino)bis[1-oxo-, sodium salt (1:2)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guidelinestudy

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Principles of method if other than guideline:

An acute oral toxicity study according OECD TG 423 was conducted. 2x3 female rats received a single dose of X-TAN (preparation of hexamethylen diisocyanatebisulfite-adducte in water). Clinical signs and mortality rates were determined several times on the day of administration and subsequently at least once daily for an observation period of at least 14 days. The weight gain ofthe animals was checked weekly until the end ofthe study. Animals which died or were killed in moribund state were weighed (except on day of administration) and dissected as so on as possible, and examined macroscopically.

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Methansulfonic acid (1,6-hexanediyl-diimino)bis[1-oxo, disodium salt

EC Number:

690-526-2

Cas Number:

38632-47-2

Molecular formula:

C8H14S2N2O8.Na2

IUPAC Name:

Methansulfonic acid (1,6-hexanediyl-diimino)bis[1-oxo, disodium salt

Details on test material:

Content of active substance was 31.94% (not used for calculation)

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

2 x 3 animals per dose

Control animals:

no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

other: cut-offm LD50

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality or clinical signs observed at 2000 mg/kg of a 31% X-Tan solution of. This corresponds to a cut-off LD50 of >= 5000 mg/kg according to Annex 2d in the OECD TG 423, which corresponds to a cut-off LD50 of 1598 mg/kg for the active ingrediant.

Applicant's summary and conclusion

Executive summary:

An acute oral toxicity study according OECD TG 423 was conducted. Two x three female rats received a single dose of X-TAN (preparation of hexamethylen diisocyanatebisulfite-adducte in water). Clinical signs and mortality rates were determined several times on the day of administration and subsequently at least once daily for an observation period of at least 14 days. The weight gain ofthe animals was checked weekly until the end ofthe study. Animals which died or were killed in moribund state were weighed (except on day of administration) and dissected as so on as possible, and examined macroscopically.

A dose of 2000 mg/kg body weight (content of active substance was not used for calculation) was tolerated by female rats without mortalities, clinical signs, toxicological effects on weight gain and gross pathological findings.