Phthalic anhydride

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

Ten healthy rats (5/sex) were exposed nose-only to a test atmosphere of phthalic anhydride of 2.14 mg/L (highest technically feasible concentration) for 4 hours. The animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days following exposure or until death occurred. Body weights were recorded prior to exposure and again on Days 7 and 14 (termination) or after death. Necropsies were performed on all animals.

GLP compliance:

yes

Test type:

other: highest technically feasible concentration used

Test material

Test material information

Constituent 1

Reference substance name:

Phthalic anhydride

EC Number:

201-607-5

EC Name:

Phthalic anhydride

Cas Number:

85-44-9

Molecular formula:

C8H4O3

IUPAC Name:

1,3-dihydro-2-benzofuran-1,3-dione

Details on test material:

purtity: 99.9%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

other: unchanged (no vehicle)

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

2.14 mg/L

No. of animals per sex per dose:

5

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2.14 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Any other information on results incl. tables

One male died upon chamber removal. There were no clinical signs noted for this animal prior to death. Following exposure, the clinical signs observed for the surviving animals included hypoactivity, abnormal respiration, reduced fecal volume, ocular discharge and facial and/or anogenital staining. However they recovered by Day 14. Although three animals lost weight by Day 7, all surviving animals gained body weight over the 14-day observation period. Gross necropsy of the decedent revealed discoloration of the lungs and liver. No gross abnormalities were noted for any of the euthanized animals when necropsied at the conclusion of the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The exact LC50 cannot be determined.
LC50 > 2.14 mg/L (aerosol) - highest technically feasible concentration.

Executive summary:

Method: according OECD 403 - ten healthy rats (5/sex) were exposed nose-only to a test atmosphere of phthalic anhydride of 2.14 mg/L (highest technically feasible concentration) for 4 hours.

Result: LC50 > 2.14 mg/L (aerosol) - following exposure, the clinical signs observed for the surviving animals included hypoactivity, abnormal respiration, reduced fecal volume, ocular discharge and facial and/or anogenital staining. However they recovered by Day 14. Although three animals lost weight by Day 7, all surviving animals gained body weight over the 14-day observation period. Gross necropsy of the decedent revealed discoloration of the lungs and liver. No gross abnormalities were noted for any of the euthanized animals when necropsied at the conclusion of the 14-day observation period.