Phthalic anhydride

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

short-term repeated dose toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Temperature in the vapor inhalation chamber raised to 60 - 70 degree Celsius, no individual animal data, no analytic of test atmosphere, limited documentation

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Zur Toxizitaet von reinem Phthalsaeureanhydrid und Rohprodukten aus der industriellen Phthalsaeuresynthese (Tierexperimentelle Untersuchungen)

Author:

Friebel H, Gross E, Immisch-Seehausen L, Linke KH, Sommer S

Year:

1956

Bibliographic source:

Arch. Gewerbepath. Gewerbehyg. 14, 465-482.

Materials and methods

Principles of method if other than guideline:

4 guinea pigs (2 animals on 4 consecutive days, 2 animals on 8 consecutive days) were exposed to the vapour of the test substance (3 different qualities) for 30 min. The impact of the vapour on the animals was studied.

GLP compliance:

no

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

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

female

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

not specified

Vehicle:

other: unchanged (no vehicle)

Remarks on MMAD:

MMAD / GSD: not applicable - vapour

Analytical verification of doses or concentrations:

yes

Duration of treatment / exposure:

2 animals on 4 consecutive days, 2 animals on 8 consecutive days

Frequency of treatment:

single

Doses / concentrations

Remarks:

Doses / Concentrations:
3 different qualities in different doses were used: see - any other information on materials and methods
Basis:

No. of animals per sex per dose:

Total (m+f): 2 animals on 4 consecutive days, 2 animals on 8 consecutive days

Control animals:

yes

Results and discussion

Effect levels

Dose descriptor:

NOAEC

Remarks on result:

not determinable

Remarks:

no NOAEC identified

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

All animals including the control animals showed irritation of conjunctiva, and irritation of lung mucosa probably because the temperature in the vapor inhalation chamber increased to 60 - 70 degree Celsius during the experiment.

Controls:
Respiration-rate (decrease of respiration rate, breathing/min)
C 78,5
P 60,6
K7 53,7
K2 41,2
closed eyelids, transient rhinitis.
Histopathology: no findings in the lung.

P:
abdominal respiration.
Histopathology: only 1 animal showed bronchitis, impaired mucous membranes and increased number of histiocytes.

K2:
increased lacrimation, complete eyelid closure, rhinitis, laboured breathing.
Histopathology: animals showed putrid bronchitis, hyperemia of the lungs.

K7:
signs of irritation, closed eyelids, lacrimation, slight rhinitis,
Cuogh-rate (per 30 min)
C 8
P 201
K7 1117
K2 343
Histopathology: slight bronchitis was seen.

Applicant's summary and conclusion

Executive summary:

4 guinea pigs ( 2 animals on 4 consecutive days, 2 animals on 8 consecutive days) were exposed to the vapour of the the test substance (3 different qualities) for 30 min. the impact of the vapour on the animals was studied.

Result: no NO(A)EL or LO(A)EL stated; all animals showed decreaswed respiration rate, closed eyelids and transient rhinitis. the histopathological examination revealed no findings in the lung.