Carboxylic acids, di-, C4-6

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Scientifically defensible or guideline method was used, study conducted according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Carboxylic acids, di-, C4-6

EC Number:

271-678-5

EC Name:

Carboxylic acids, di-, C4-6

Cas Number:

68603-87-2

Molecular formula:

C5H8O4, C4H6O4, C6H10O4

IUPAC Name:

68603-87-2

Details on test material:

AGS Mixture: lot No.5/9/83 PENSACOLA: adipic acid: 3.9%; Glutaric acid: 16.43%; succinic acid 4.77% and nitric acid 3.9%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

13 weeks

Frequency of treatment:

daily

Doses / concentrations

Remarks:

Doses / Concentrations:
3, 10 and 30%
Basis:
actual ingested

No. of animals per sex per dose:

15 males and 15 females

Control animals:

yes, concurrent vehicle

Results and discussion

Effect levels

Dose descriptor:

NOEL

Effect level:

3 other: % test compound in 10 ml application volume

Sex:

male/female

Basis for effect level:

other: corresponds to approx. 195 mg dicarboxylic acid/kg body weight; effects at higher doses: decrease in urinary pH; slight reduction in body weight

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

Three high dose (30% AGS-Mixture) males and one high dose female died during the study. Apart from one animal which died as a result of a gavage injury, no cause of death could be determined. No mortalities occurred at the lower dose levels or in the control animals. Effects observed at the high dose (30%) included weight reduction in males and female, reduced food consumption, clinical observation of labored breathing and/or rate. Similar findings were seen at the mid dose (10%), but these observations were not as severe in magnitude or did not affect as many animals. A statistically significant increase in leukocytes was seen in males the 30% group. Urinary pH was significantly decreased in both genders at the high dose and in males at the mid dose. There was no test article related effects seen at necropsy or on histopathological examination. The authors concluded that the No-Effect-Level in this study was 3% AGS-Mixture.