Triammonium citrate

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:

data from handbook or collection of data

Data source

Reference

Reference Type:

review article or handbook

Title:

SIDS Initial Assessment Report For SIAM 19

Author:

OECD

Year:

2004

Bibliographic source:

OECD SIDS initial assessment report

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Description of methods used in BASF acute toxicity and skin/eye irritation studies before pertinent OECD/EU test guidelines were in place (BASF AG, 2002)

Version / remarks:

2002

Deviations:

no

Principles of method if other than guideline:

- Principle of test: Description of methods used in BASF acute toxicity and skin/eye irritation studies before pertinent OECD/EU test guidelines were in place; similar to standard acute method
- Short description of test conditions: The test substance was given by single gavage to groups of rats at various dose levels as a 30% aqueous solution. 10 male and 10 female rats were used per dose level. The LD50 was calculated according to the method described by Litchfield-Wilcoxon.
- Parameters analysed / observed: not reported

GLP compliance:

not specified

Test type:

other: similar to standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium sulphate

EC Number:

231-984-1

EC Name:

Ammonium sulphate

Cas Number:

7783-20-2

Molecular formula:

H3N.1/2H2O4S

Test material form:

solid

Test animals

Species:

rat

Strain:

other: Gassner Strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Test substance was applied as 30% solution

Doses:

2500, 3200, 4000, 5000, 6400 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

not specified

Statistics:

The LD50 was calculated according to the method described by Litchfield-Wilcoxon.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 250 mg/kg bw

Based on:

test mat.

95% CL:

>= 3 788 - <= 4 769

Mortality:

Group 6400 mg/kg bw: 12 died within the first hour, 2 within 24 hours, 4 within 48 hours; in total, 18/20 died within 7 days.
Group 5000 mg/kg bw: 8 died within the first hour, 1 within 24 hours, 1 within 48 hours; in total 11/20 died within 7 days.
Group: 4000 mg/kg bw: 7 died within 24 hours, and 2 within 48 hours; in total, 9/20 died within 7 days.
Group 3200 mg/kg bw: 1 animal died within the first hour, 1 within 24 hours, 2 within 48 hours; in total, 4/20 died within 7 days.
Group 2500 mg/kg bw: no deaths occurred.

Clinical signs:

4000-6400 mg/kg bw: immediately after application staggering, abdominal and lateral position, partly dorsal position, apathy, laboured and irregular breathing. On the next day, secretion out of eyes and mouth, reddened eyes and nose. In the post-exposure observation days the animals were without clinical symptoms.
3200 mg/kg bw: No symptoms on the application day. The next day, reddened eyes and nose, and irregular breathing were noted. Later without clinical signs.
2500 mg/kg bw: No clinical signs noted.

Gross pathology:

At necropsy, fluid in the thoracic cavity was observed in a few animals. In three animals, the stomach was filled with liquid, and bloody mouth and forelegs were noted. No pathological findings were noted with regard to the inner organs.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the study which was reported in the OECD SIDS report (2004) the LD50 value of 4250 mg/kg bw was determined using the Litchfield-Wilcoxon Method, thus the substance does not need to be classified according to Regulation (EC) No. 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).

Executive summary:

According to the study which was reported in the OECD SIDS report (2004) the LD50 value of 4250 mg/kg bw was determined using the Litchfield-Wilcoxon Method, thus the substance does not need to be classified according to Regulation (EC) No. 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).