1-chloro-2-nitrobenzene

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Highest dose was too high; only summary available

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1990

Reference 2

Reference Type:

other: OECD SIDS

Title:

Unnamed

Year:

2001

Reference 3

Reference Type:

other: US EPA Status Report

Title:

Unnamed

Year:

1990

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

25 females/group, due to severe maternal toxicity and mortality the 150 mg/kg bw/day level was terminated prior to scheduled sacrifice.

GLP compliance:

yes

Limit test:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Purity: commercial

Test animals

Species:

rat

Strain:

Sprague-Dawley

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

days 6-15 of gestation

Duration of test:

21 days

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 25, 75, 150 mg/kg bw
Basis:
nominal conc.

No. of animals per sex per dose:

25 females/dose

Control animals:

yes, concurrent vehicle

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Details on maternal toxic effects:
Mortality:
At 150 mg/kg all dams were terminated prior to scheduled sacrifice because of severe toxicity and high mortality
At 75 mg/kg 1 dam died.

General toxicity:
At 75 mg/kg: between gestation days 6-10 reduced body weight gain (slight but not significant) and reduced food consumption; recovery later in gestation; urinary staining, alopecia; maternal reproductive parameters comparable to controls, mean number of early resorptions and post implantation loss slightly increased (post implantation loss in the respective control very low compared to historical control; values range: 0-0.9).
At 25 mg/kg: no evidence of maternal toxicity.

Effect levels (maternal animals)

1

Dose descriptor:

NOAEL

Effect level:

ca. 25 mg/kg bw/day (nominal)

Based on:

test mat.

Basis for effect level:

other: maternal toxicity

2

Dose descriptor:

NOAEL

Based on:

test mat.

Basis for effect level:

other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Details on embryotoxic / teratogenic effects:
Fetal body weight comparable to control.
Variations: cervical #7 ribs at 25 mg/kg bw/day (1.1%) and significant at 75 mg/kg (2%); 13 full pairs of ribs with lumbar #1 rudimentary ribs in controls, at 25 mg/kg, 75 mg/kg increased, but not significant; 12 full pair of ribs with #13 unilateral full rib and/or rudimentary rib(s) in controls and in 25 mg/kg increased, but not significant

A NOAEL for developmental toxicity could not be conclusively derived.

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified