Carboxylic acids, di-, C4-6

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

Principles of method if other than guideline:

Animals were observed for 14 days

GLP compliance:

no

Test type:

standard acute method

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:

Carboxylic acids, C4-6 di-

Details on test material:

Test Material: dibasic acid concentrate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

6 dose level; 3160; 3980; 5010; 6310; 7940; 10000 mg/kg bw

No. of animals per sex per dose:

2-3 males; 2-3 females; overall 5 animals per dose group

Control animals:

no

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

3 980 mg/kg bw

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

6 000 mg/kg bw

95% CL:

>= 5 400 - <= 6 720

Mortality:

see Table 1

Any other information on results incl. tables

Signs of intoxication: weight loss (one day in survivors), increasing weakness, salvation, collapse and death.

Gross autopsy:

5010 and 6310 mg/kg group: Hemorrhagic lungs, liver, kidney and spleen discoloration and acute gastrointestinal inflamation.

7940 and 10000 mg/kg group: Lung and liver hyperemia

Survivors (day 14): Viscera appeared normal.

Table 1: mortalities

Dosage (mg/kg bw)	mortality males	mortality females	mortality combined
3160	0/3	0/2	0/5
3980	0/2	0/3	0/5
5010	1/3	0/2	1/5
6310	0/2	3/3	3/5
7940	3/3	2/2	5/5
10000	2/2	3/3	5/5

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

An oral LD50 value of 6000 mg/kg (95% confidence limits 5400 - 6720 mg/kg) was reported in rats in study similar to OECD TG 401 with doses up to 10000 mg/kg. In this study a 20% aqueous solution of a dicarboxylic acid mixture was tested and mortality was seen during the first 4 days; most deaths were reported within the first day. Signs of intoxication were weight loss (one day in survivors), increased weakness, salvation, collapse and death. Lethal doses caused hemorrhagic lungs, liver, kidney and spleen discoloration and acute gastrointestinal inflamation. Animals that survived to termination (day 14) appeared normal.