Terephthalic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No information; study reported in 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Older, proprietary and guideline-comparable study pre-dating the introduction of GLP

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Test guideline 1

Qualifier:

no guideline followed

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Standard acute oral toxicity study method comparable to OECD 401, but performed prior to the adoption of this guideline

GLP compliance:

not specified

Remarks:

: older study, pre-dates GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Terephthalic acid

EC Number:

202-830-0

EC Name:

Terephthalic acid

Cas Number:

100-21-0

Molecular formula:

C8H6O4

IUPAC Name:

benzene-1,4-dicarboxylic acid

Test material form:

not specified

Details on test material:

Terephthalic acid TA-12. The purity was not stated. However, terephthalic acid is a monomer used in the production of saturated polyesters, and a purified (> 99.9% w/w) feedstock (free of production-process impurities) is essential for this purpose. The batch of terephthalic acid used in this study is considered to have been representative of commercial production and to have been at least 99% pure.

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

Male and female albino rats

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

corn oil

Details on oral exposure:

Terephthalic acid was administered orally to rats as a 40% (w/v) homogenous suspension in corn oil

Doses:

6834, 10250, and 15380 mg/kg bw.

No. of animals per sex per dose:

5 rats per sex per dose

Control animals:

no

Details on study design:

The test substance was administered orally at three dose levels to groups of 5 male and 5 female albino rats. Rats were observed for clinical signs and mortality for 14 days post administration. Necropsy was performed on all rats that died during the test, and on all surviving rats at the end of the 14 day observation period. Body weights were recorded on test days 0 and 14.

Statistics:

Not applicable - not required

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 380 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths at the highest dose level

Mortality:

The only deaths that occurred were in the mid dose group (10250 mg/kg); 1 female died within 22 hours of administration, and 1 male died on day 3.

Clinical signs:

other: Clinical signs observed at all dose levels included hypoactivity, ruffled fur, diarrhoea, muscular weakness and rhinitis

Gross pathology:

The two rats that died before the end of the study were found to have pale discoloured kidneys at necropsy. Examination of the rats surviving to the end of the 14 day observation period did not reveal any gross pathologic alterations.

Other findings:

No other findings reported.

Any other information on results incl. tables

The onset and recovery of clinical signs observed in rats following oral administration with terephthalic acid is shown below.

Clinical signs	Dose level of terephthalic acid (mg/kg bw)
	6834		10250		15380
	Onset	Recovery	Onset	Recovery	Onset	Recovery
Hypoactivity	6-22 h	3 d	30 m	6 d	30 m	7 d
Ruffled fur	6-22 h	3 d	30 m	6 d	30 m	6 d
Diarrhoea	6-22 h	2 d	6-22 h	4 d	1 h	5 d
Muscular weakness	6-22 h	2 d	6-22 h	5 d	6-22 h	5 d
Rhinitis	-	-	2 d	6 d	6-22 h	6 d

d =days, h =hours, m =minutes

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of terephthalic acid in rats is greater than 15380 mg/kg bw.

Executive summary:

Terephthalic acid in corn oil was administered orally by gavage to male and female rats at dose levels of 6834, 10250 and 15380 mg/kg bw. Rats were observed for 14 days following administration. The only deaths that occurred were in the mid dose group (10250 mg/kg bw); 1 female died within 22 hours of administration, and 1 male died on day 3. Gross necropsy revealed that these rats had pale discoloured kidneys. Clinical signs observed at all dose levels included hypoactivity, piloerection, diarrhoea, muscular weakness and rhinitis. Minimal transient weight loss was observed in individual animals; however there were no effects on body weight gain over the 14-day study period. Gross necropsy of all animals surviving to the end of the 14-day observation period did not reveal any abnormalities. The acute oral LD50 of terephthalic acid in the rat is therefore shown to be >15380 mg/kg bw under the conditions of this study.