Sodium [N-[2-[bis(carboxylatomethyl)amino]ethyl]-N-(2-hydroxyethyl)glycinato(3-)]zincate(1-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

REPORTING FORMAT FOR THE CATEGORY APPROACH

1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
See the documentation in support for the category approach.

2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL
See the documentation in support for the category approach.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of potassium;sodium;2-[bis[2-[bis(carboxymethyl)amino]ethyl]amino]acetate;copper and potassium;sodium;2-[2-[bis(carboxymethyl)amino]ethyl-(2-hydroxyethyl)amino]acetate;copper

IUPAC Name:

Reaction mass of potassium;sodium;2-[bis[2-[bis(carboxymethyl)amino]ethyl]amino]acetate;copper and potassium;sodium;2-[2-[bis(carboxymethyl)amino]ethyl-(2-hydroxyethyl)amino]acetate;copper

Test material form:

solid

Remarks:

solid with lumps

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One mortality was noted in the animals treated at the dose of 2000 mg/kg body weight (1/6), on day 5 during the step 3.

Clinical signs:

other: In the surviving animals (5/6), no clinical signs related to the administration of the test item were observed during the study. No clinical signs related to the administration of the test item were observed before the death.

Gross pathology:

The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
The macroscopic examination of the dead animal at the end of the study did not reveal treatment related changes.

Other findings:

For the dead animal, rigor mortis and beginning of cannibalism were noted before the necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item Reaction mass of CuDTPA and CuHEDTA is higher than 2000 mg/ kg body weight by oral route in the rat. In accordance with the O.E.C.D. Test Guideline No. 423, the LD50 cut-off of the test item may be considered as 2500 mg/ kg body weight by oral route in the rat.
The test item Reaction mass of CuDTPA and CuHEDTA does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.

Executive summary:

The test item Reaction mixture of CuDTPA and CuHEEDTAwas administered to a group of 6 female Sprague Dawley rats at the dose of 300 mg/kg body weight and then to a group of 6 female Sprague Dawley rats at the dose of 2000 mg/kg body weight. The experimental protocol was established according to the official method as defined inthe O.E.C.D. Test Guideline No. 423 dated December 17th, 2001 and the test method B.1tris of the Council regulation No. 440/2008.

No mortality was noted in the animals treated at the dose of 300 mg/kg body weight. No clinical signs related to the administration of the test item were observed during the study. The body weight evolution of the animals remained normal during the study. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.

One mortality was noted in the animals treated at the dose of 2000 mg/kg body weight (1/6), on day 5. No clinical signs related to the administration of the test item were observed before the death. An absence of body weight gain was noted on day 2 versus day 0. Then, a decrease of body weight (-23%) was noted on day 5 versus day 0.Rigor mortis and beginning of cannibalism were noted before the necropsy. The macroscopic examination of the animal at the end of the study did not reveal treatment related changes.

In the surviving animals (5/6), no clinical signs related to the administration of the test item were observed during the study. The body weight evolution of the animals remained normal during the study. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.

In conclusion, the LD50of the test itemReaction mixture of CuDTPA and CuHEEDTAis higher than 2000 mg/ kg body weight by oral route in the rat.
In accordance with the O.E.C.D. Test Guideline No. 423, the LD50cut-off of the test item may be considered as 2500 mg/ kg body weight by oral route in the rat.

The test itemReaction mixture of CuDTPA and CuHEEDTA does not have to be classifiedin accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
No signal word or hazard statement is required.