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Toxicological information

Acute Toxicity: oral

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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:
other: Scientifically defensible or guideline method was used, no GLP

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:
other: Similar to OECD TG 401

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:
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; 3,160 - 10,000 mg/kg;
No. of animals per sex per dose:
2-3 males; 2-3 females; overall 5 animals per group
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
3 980 mg/kg bw
Sex:
male/female
Dose descriptor:
LD50
Effect level:
6 000 mg/kg bw
95% CL:
>= 5 400 - <= 6 720

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.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.