Methyl p-toluate

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given (with respect to embryotoxic and teratogenic effects)

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

A study of embryotoxic and teratogenic action of some industrial substances formed during production of dimethylterephthalate

Author:

Krotov YA & Chetobar NA

Year:

1972

Bibliographic source:

Gig. Truda Prof. Zabol, Vol. 16, 40-43

Report date:

1972

Materials and methods

Principles of method if other than guideline:

Developmental toxicity study

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methyl p-toluate

EC Number:

202-784-1

EC Name:

Methyl p-toluate

Cas Number:

99-75-2

Molecular formula:

C9H10O2

IUPAC Name:

methyl 4-methylbenzoate

Test material form:

other: vapour

Details on test material:

- Name of test material (as cited in study report): paratoluic methylate (PTE)

Test animals

Species:

rat

Strain:

other: white

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure (if applicable):

whole body

Vehicle:

air

Analytical verification of doses or concentrations:

not specified

Details on mating procedure:

no data

Duration of treatment / exposure:

24 h per day for 20 days

Frequency of treatment:

daily

Duration of test:

20 days

Doses / concentrations

Remarks:

Doses / Concentrations:
150 mg/m3
Basis:
nominal conc.

No. of animals per sex per dose:

29 pregnant females

Control animals:

yes, concurrent no treatment

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:

LOAEC

Effect level:

150 mg/m³ air (nominal)

Basis for effect level:

other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Effect levels (fetuses)

Dose descriptor:

LOAEC

Effect level:

150 mg/m³ air

Based on:

test mat.

Basis for effect level:

other: embryotoxicity

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Any other information on results incl. tables

Increased pre- and postimplantation losses (preimplantation losses of 32,9 % and 11.3 %; percentage of postimplantation losses: 49.3 % vs. 4.8 % in controls). The authors considered pre- and postimplatation losses of 20 % and 15 % as normal values.

Few gross and microscopic alterations (e.g. shortened tail, adactylia, cryptorchism, hydronephrosis) were observed, but were considered to be sponaneous effects (only offspring of a single dam was affected, or incidences were comparable to control group)

Maternal effects of the study were not stated, but effects in former examinations at "similar exposure concentrations" were reported: altered activity of cholinesterase, altered chronaxy, blood proteins and histomorphology (no further details)

A further study with single 24 h exposure to 750 mg/m3 on gestation day (GD) 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 or 14 revealed no embryotoxic or teratogenic effects. A total of 10 maternal animals died on GD 5, 6, 7, 8, 10 and 13.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, embryotoxic effects were oberved at maternal toxic exposures and are therefore considered to be secondary effects to maternal toxicity. The exposure did not produce other developmental effects including teratogenicity.