Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: other route
Remarks:
intraperitoneal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Follows a methodology which is comparable in part with standard guidelines, does not have GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1978

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
In a non-standard study, unspecified groups of rats and mice were treated by intraperitoneal route for 10 successive days.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Citric acid
EC Number:
201-069-1
EC Name:
Citric acid
Cas Number:
77-92-9
Molecular formula:
C6H8O7
IUPAC Name:
2-hydroxypropane-1,2,3-tricarboxylic acid

Test animals

Species:
rat

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other:
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
Once daily
Frequency of treatment:
10 days
Doses / concentrations
Remarks:
Doses / Concentrations:
250 mg/kg/day, 500 mg/kg/day, 1000 mg/kg/day, 2000 mg/kg/day
Control animals:
yes, concurrent no treatment
Details on study design:
Post observation period: 10 days where animals were observed for clinical signs.

Examinations

Observations and examinations performed and frequency:
Groups of rats and mice were exposed to a single oral dose by the intraperitoneal route over a ten day period. The dose groups comprised 250 mg/kg/day, 500 mg/kg/day, 1000mg/kg/day and 2000 mg/kg/day respectively, and included a control group.

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
250 mg/kg bw (total dose)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: no data

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
No reporting on clinical observations was provided in the original study. The results gave a NOAEL = 250 mg/kg (bw) via the intraperitoneal route for both the rat and mice.