Chromium tris((2-ethylhexanoate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017-01-20 to 2017-03-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

dated December 17th, 2001

Deviations:

yes

Remarks:

Environmental parameters : relative humidity lower than 30% (minimum = 18%) and temperature higher than 25°C (maximum= 29°C) reported - these deviations are considered without impact on the conclusion of the study.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Remarks:

dated October 23rd, 2015

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Chromium tris((2-ethylhexanoate)

EC Number:

222-357-3

EC Name:

Chromium tris((2-ethylhexanoate)

Cas Number:

3444-17-5

Molecular formula:

Cr(C8H16O2)3

IUPAC Name:

chromium(3+); 2-ethylhexanoate

Test material form:

other: Solid/paste

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER LABS, Le Genest St Isle, France
- Age at study initiation: 8 weeks old at the beginning of the study
- Weight at study initiation: 189 - 212 g
- Fasting period before study: Food was removed o day 1 and then redistributed 4 hours after adminsitration of the test item.
- Housing: Animals were housed by group of three in solid-bottomed clear plycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust and was installed in conventional air conditioned animal husbandry
- Diet (ad libitum): Envigo - 2016
- Water: ad libitum
- Acclimatization period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
- Rate of air exchange : at least 10 changes per hour

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: ethanol in olive oil (2/8, w/w)

Details on oral exposure:

In the first step of the study, 2.9515 g of the test item were weighted and the formulation ethanol (2.36 g) / olive oil (9.45 g) was added to obtain a preparation weighing 14.76 g.
In the second step of the study, 2.1164 g of the test item were weighted and the formulation ethanol (1.69 g) / olive oil (6.77 g) was added to obtain a preparation weighing 10.58 g.
The preparations were stirred magnetically and by vortex to obtain green homogeneous emulsions just before the administration.
Each preparation was administered under a volume of 10 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.

Doses:

2000 mg/kg

No. of animals per sex per dose:

2000 mg/kg: 3 + 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Daily examination: Systematic examination were carried out to identify any behavioural or toxic effects on the major physiological functions during 14 days following the administration of the test item. These observations were compared to historical control data. Clinical observations and mortality were recorded every day for 14 days.
- Periodical examinations: The animals were weighed on D0 (just before administering the test item) then on D2, D7 and D14. Weight changes were calculated and recorded.
- Examination at the end of the test: On D14, the animals were anesthetised with sodium pentobarbital (Dolethal). Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. No organ was removed and preserved in view to microscopic examinations.

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 mortality occured during the study.

Clinical signs:

other: other: No clinical signs related to the administration of the test item were observed during the study.

Gross pathology:

The macrosscopic examination of the animals at the end of the study did not reveal treatment related changes.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat.
The test item does not have to be classified in accordance with the Regulation EC n° 1272/2008 on classification, labelling and packaging of substances and mixtures. No signal word or hazard statement is required.