Selenium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996-01-16 to 1996-02-02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

February 24, 1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

31 July 1992

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Selenium

EC Number:

231-957-4

EC Name:

Selenium

Cas Number:

7782-49-2

Molecular formula:

Se

IUPAC Name:

selenium

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Selenium powder 200
- Substance type: inorganic

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Wistar outbred rat; Crl :(WI) WU BR; Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: 5 -6- weeks old upon arrival
- Weight at study initiation: males 278 to 299 g, females 158 to 183 g
- Fasting period before study: fasted overnight
- Housing: five animals per cage (stainless steel cages, fitted with wirescreen floor and front)
- Diet (e.g. ad libitum): standard laboratory rodent diet ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 41 or 44 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%):between 42.5-75%
- Air changes (per hr): ca 10 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours Iight/12 hours dark cycle

IN-LIFE DATES: From 1995-12-06 To: 1996-02-02

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

maize oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10mL/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

A screening was carried out with two females, since no mortality was observed, the study was continued with three males and five females

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made within 1 hour and within 4 hours after dosing, and subsequently at least
once daily throughout an observation period of 14 days.
Body weight of each animal was recorded immediately before dosing on day 0, and on day 3, 7 and 14 of the study.
- Necropsy of survivors performed: yes; the abdomen and the thorax of each animal was opened and examined for gross pathological changes.
- Other examinations performed: clinical signs

Statistics:

No data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No animal died

Mortality:

No mortality occurred

Clinical signs:

other: Sluggishness was observed in 3 males and in 1 female. Piloerection was observed in all males and females. Diarrhoea was observed in 2 males and in 3 female at 24 and 48 hours after dosing. Apart from some signs of alopecia in all females prior to and duri

Gross pathology:

Examination of the animals at autopsy did not reveal any treatment-related gross alterations.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP; EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

The LD50 for Selenium (powder) was determined to be > 5000 mg/kg bw .

Executive summary:

In an acute oral toxicity study according to OECD Guideline 401 (Acute Oral Toxicity), wistar rats (5 animals/sex) were given a single oral dose of 5000, mg/kg bw Selenium (powder) in maize oil and observed for 14 days.

No mortality occurred during the 14-day observation period, apart from sluggishness, piloerection and diarrhoea, no other clinical symptoms were observed.

A slight dip in body weight was observed on day 3 of the study only. Macroscopic examination of the animals at the end of the observation period did not reveal any treatment-related gross alterations.

In conclusion since no mortality occurred during the 14-day observation period, the oral LD50, of Selenium (powder) is considered to exceed 5000 mg/kg body weight, in both male and female rats.