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Diss Factsheets

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: no guideline conform study

Data source

Reference
Reference Type:
publication
Title:
Investigations on the acute toxic, cytogenetic, and embryotoxic activity of phenyl isocyanate and diethoxyphosphoryl isocyanate
Author:
Nehez M, Fischer GW, Nehez I, Scheufler H, Desi I
Year:
1989
Bibliographic source:
Ecotoxicology and Environmental Safety 17, 258-263

Materials and methods

Principles of method if other than guideline:
Embryotoxic effects were studied following oral administration of phenyl isocyanate (1/20 LD50) in olive oil to pregnant mice at days 4, 7, 11 and 15 of gestation. On day 18 of gestation the mice were sacrificed and reproductive status was determined (numbers of corpora lutea and dead and alive fetuses).
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Phenyl isocyanate
EC Number:
203-137-6
EC Name:
Phenyl isocyanate
Cas Number:
103-71-9
Molecular formula:
C7H5NO
IUPAC Name:
isocyanatobenzene
Details on test material:
Phenyl isocyanate was purchased from Merck (Darmstadt, FRG) The test compound was freshly destilled in vacuo before use (boiling point 54°C/16 mm)

Test animals

Species:
mouse
Strain:
other: Halle-AB-Jena and Halle-DBA

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
olive oil
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
no data
Duration of treatment / exposure:
4., 7., 11. and 15. day of gestation
Frequency of treatment:
once a day
Duration of test:
On day 18 of gestation the mice were sacrificed
No. of animals per sex per dose:
no data
Control animals:
yes, concurrent vehicle
Details on study design:
Sex: female

Results and discussion

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
9.8 mg/kg bw/day
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

The following parameters were comparable with the control:
Corpora lutea, total implants, living implants, preimplantation, postimplantation and total implantation losses.

Applicant's summary and conclusion

Conclusions:
After oral administration of 9.8 mg/kg phenyl isocyanate to pregnant mice at various days of gestation (4, 7, 11, or 15), phenyl isocyanate was not embryotoxic. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
Executive summary:

Embryotoxic effects were studied following oral administration of phenyl isocyanate (1/20 LD50) in olive oil to pregnant mice at days 4, 7, 11 and 15 of gestation. On day 18 of gestation the mice were sacrificed and reproductive status was determined (numbers of corpora lutea and dead and alive fetuses).

After oral administration of 9.8 mg/kg phenyl isocyanate to pregnant Halle-AB Jena and Halle-DBA mice at various days of gestation (4, 7, 11, or 15), phenyl isocyanate was not embryotoxic.