Isophthalic acid

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No information, data reported in 1958

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1958

Report date:

1958

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

The study was conducted as a range-finder and is essentially the same as OECD 403. Only one (very high) concentration was tested.

GLP compliance:

no

Remarks:

predates GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isophthalic acid

EC Number:

204-506-4

EC Name:

Isophthalic acid

Cas Number:

121-91-5

Molecular formula:

C8H6O4

IUPAC Name:

isophthalic acid

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Isophthalic acid was recevied from Amoco Chemicals Corporation

Specific details on test material used for the study:

Isophthalic acid was recevied from Amoco Chemicals Corporation
Test material is a powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The animals were young adult male and female Sprague-Dawley rats, with an average body weight of 120 g. Rats underwent a 14 day observation period prior to testing to ensure their health and suitability as test animals. During the observation period, the rats were housed individually in stock cages, standard rat diet and water were provided ad libitum (food was withdrawn 24 hours prior to exposure).

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

On the day of testing, a group of 10 rats was placed in a glass exposure chamber with a volume if 0.036 m³. A Wright Dust Feed Mechanism was connected to the chamber which introduced the test material into the chamber in the form of a finely divided dust. The rats were exposed continuously for 4 hours. The chamber was operating at maximum working capacity during the entire exposure period. The air delivery rate into the chamber was 10 L/min (0.010 m³/min), pressure was 758 mm Hg and temperature was 27°C.
Particle size was 1 to 5 microns.

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Concentrations:

11.37 mg/L (11370 mg/m³)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Food was withdrawn for 24 hours prior to exposure. The rats were closely observed during the exposure period for reactions to the test atmosphere. After the four hour exposure period, the rats were returned to their stock cages and permitted food and water ad libitum. The rats were observed for a further 14 days.

Statistics:

None required

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 11 370 mg/m³ air

Exp. duration:

4 h

Remarks on result:

other: no deaths occurred at this single test concentration

Mortality:

No deaths occurred

Clinical signs:

other:

Body weight:

Not measured.

Gross pathology:

Not performed.

Other findings:

No other findings reported.

Any other information on results incl. tables

There were no deaths and no signs of toxicity in rats following a 4 hour exposure to 11370 mg/m³ isophthalic acid dust.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

There were no deaths and no signs of toxicity in rats following a 4 hour exposure to 11370 mg/m³ isophthalic acid dust.

Executive summary:

Five male and five female Sprague-Dawley rats were exposed to 11370 mg/m³ isophthalic acid dust for four hours. The particle size was reported to be 1 to 5 microns. No deaths occurred during the study, and no signs of toxicity were observed during the exposure period or the 14 day post-exposure period. The LC50 is therefore greater than 11370 mg/m3.