Tripotassium citrate

Repeated dose toxicity: oral

Administrative data

Endpoint:

repeated dose toxicity: oral

Remarks:

other: non-standard (see below)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reasonably well documented study meeting generally accepted scientific principles but not conducted in compliance with GLP. Study acceptable for assessment. This result was obtained by valid read-across.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Principles of method if other than guideline:

In a non-standard study, groups of 10 rats of each sex were treated by gavage for 5 successive days with a further 10 days observation. Body weights were recorded prior to treatment and following the 5th administration. (Group numbers are not given in the 2-page report seen by this reviewer, however SIAR (2001), reviewing the same study (possibly with a fuller report). has identified group numbers.)

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Citric acid

EC Number:

201-069-1

EC Name:

Citric acid

Cas Number:

77-92-9

IUPAC Name:

citric acid

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

administration on 5 successive days.

Frequency of treatment:

daily

No. of animals per sex per dose:

10 (based on data from SIAR, 2001)

Control animals:

not specified

Results and discussion

Effect levels

1

Dose descriptor:

NOAEL

Effect level:

4 000 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: overall effects clinical signs; mortality; body weight NOAEL values for males and females were identical.

2

Dose descriptor:

LOAEL

Effect level:

8 000 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: overall effects clinical signs; mortality; body weight LOAEL values for males and females were identical

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

Table 1: Study design - Animal assignment

Test Group	Dose to each sex (mg/kg bw)
1	2000
2	4000
3	8000
4	16000

Table 2: Mortality and body weight gains during 5 days of treatment and 10 days of observation

	Male							Female
Dose rate (g/kg bw/day)	Mortality% (treatment day)					Mortality% (after 10 days observation)	Total Weight Gain 24 h after 5^th administration (g)	Mortality% (treatment day)					Mortality% (after 10 days observation)	Total Weight Gain 24 h after 5^th administration (g)
	1	2	3	4	5			1	2	3	4	5
2	0	0	0	0	0	0	19.4	0	0	0	0	0	0	14.0
4	0	0	0	0	0	0	15.9	0	0	0	0	0	0	17.7
8	30	70	80	80	100	100	-	70	80	80	90	100	100	-
16	70	100	100	100	100	100	-	100	100	100	100	100	100	-

 

Applicant's summary and conclusion

Conclusions:

A fairly limited report of an unspecified study without guideline or GLP compliance, identified 5-day NOAEL and LOAEL values in male and female rats of 4 and 8 g/kg bw/day, respectively. The 5-day LD50 was given as 5.6 (+/- 0.44) g/kg bw/day. For each of these values, the results for males and females, tested separately, were identical.