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Toxicological information

Repeated dose toxicity: oral

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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

Constituent 1
Chemical structure
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.

Applicant's summary and conclusion