Di(µ-2,2´,2´´-nitrilotris(ethanol)-diperchlorato)dinatrium

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:

other: GLP-study of the acute oral toxicity in the rat according to OECD guideline 423

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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

The pure active substance was used.
Purity: 99%
Batch number: Catena-08-183
Production date: 16.05.2008
Expiry date: 05.2009
Storage: Closed vessel at room temperature in the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Rats originated from Elevage Janvier (53940 Le Genest St Isle, France) and were allowed at least 5 days of acclimatisation.
At the beginning of the study, treated rats were 8 weeks old and weighted between 179 and 204g.
Rats were kept in solid-bottomes clear polycarbonate cages with a stainless steel mesh lid in conventional airconditioned animal husbandry. Sawdust bedding was changed at least twice a week. Environmental conditions were: 19-23°C, relative humidity of 41-70%, 12h light per day, rate of air excange at least 10 times /h.
Drinking tap water and food was supplied freely until start of the experimental part of the study and redistributed four hours after test substance administration.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test substance was diluted and administered by gavage in a volume of 10ml/kg body weight using a syringe with an oesophageal metal canula.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

3 per step (two steps)

Control animals:

no

Details on study design:

none

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: Acc. to OECD 423, the LD50 can be considered > 5000 mg/kg body weight by oral route in the rat.

Mortality:

No mortality occured during the study.

Clinical signs:

A decrease of the spontaneous activity was registered in all treated animals after three hours after adminsitration. The animal recovered during the second test day.

Body weight:

The body weight evolved normally during the study.

Gross pathology:

Macroscopical examination of the animals at the end of the stidy did not reveal treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The substance is practically nontoxic. The substance does not need to be classified.

Executive summary:

The LD50 of the test substance is higher than 2000 mg/kg body weight by oral route in the rat.

According to OECD guideline 423, the LD50 can be considered higher than 5000 mg/kg body weight by oral route in the rat.

Therefore, no category needs to be assigned to the substance. No signal word and hazard statement are required.