Tetrachlorophthalic anhydride

Toxicity to reproduction

Administrative data

Endpoint:

fertility, other

Remarks:

based on test type (migrated information)

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Principles of method if other than guideline:

Groups of 15 male and 15 female Sprague-Dawley rats/ dose group were exposed six hours per day, five days per week for 13 weeks at analytical concentrations of 0, 0.73, 4.15 and 36.3 mg/m3. All animals were observed daily for clinical signs. At necropsy, tissues including gonads (ovaries, testes and epididymis) were subjected to complete histopatholoical examination.

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tetrachlorophthalic anhydride

EC Number:

204-171-4

EC Name:

Tetrachlorophthalic anhydride

Cas Number:

117-08-8

Molecular formula:

C8Cl4O3

IUPAC Name:

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

Details on test material:

- Name of test material (as cited in study report): Tetrathal
- Supplier: Monsanto Chemical Company
- Physical state: fines-dust form

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Age at study initiation: 53 days
- Weight at study initiation: males 271 g (244-295), females 170 g (138-194)
- Diet (e.g. ad libitum): Purina Laboratory Rodent Chow 5001
- Water (e.g. ad libitum): tap water
- Acclimation period: 2 weeks

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure (if applicable):

whole body

Vehicle:

unchanged (no vehicle)

Analytical verification of doses or concentrations:

yes

Duration of treatment / exposure:

13 weeks

Frequency of treatment:

6 hours/day, 5 days/week

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 0.73, 4.15 and 36.3 mg/m3
Basis:
analytical conc.

No. of animals per sex per dose:

15

Control animals:

yes, concurrent vehicle

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:

NOAEC

Effect level:

> 36.3 mg/m³ air (analytical)

Sex:

male/female

Basis for effect level:

other: no effects on reproductive organs

Overall reproductive toxicity

Reproductive effects observed:

not specified

Any other information on results incl. tables

No histopathological changes in the other reproductive organs of male and female animals were observed.