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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: adopted according to OECD SIDS, peer reviewed data

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
SIDS Initial Assessment Report (SIAR): 1-Chloro-4-nitrobenzene CAS No: 100-00-5
Author:
OECD SIDS
Year:
2003
Bibliographic source:
OECD SIDS, UNEP Publications
Reference Type:
study report
Title:
Unnamed
Reference Type:
publication
Title:
No information
Author:
Nair RS, Johannsen FR, Schroeder RE (1985) Evaluation of|Teratogenic Potential of Para-Nitroaniline and|Para-Nitrochlorobenzene in Rats and Rabbits. In: Toxicity of|Nitroaromatic Compounds (Rickert, D.E. ed.): pp. 61-85,|Hemisphere Publishing Corporation, New York

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Principles of method if other than guideline:
Method: other: according to OECD Guide-line 414: 24 mated rats per group, see also freetoxt ME
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-chloro-4-nitrobenzene
EC Number:
202-809-6
EC Name:
1-chloro-4-nitrobenzene
Cas Number:
100-00-5
Molecular formula:
C6H4ClNO2
IUPAC Name:
1-chloro-4-nitrobenzene
Details on test material:
- Name of test material (as cited in study report): 1-chloro-4-nitrobenzene
- Analytical purity: > 99 %

Test animals

Species:
rat
Strain:
Sprague-Dawley

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
days 6-19 of gestation
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 5, 15 or 45 mg/kg bw/day, dissolved in corn oil
Basis:

Control animals:
yes, concurrent vehicle
Details on study design:
Sex: female

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
LOAEL
Effect level:
ca. 5 mg/kg bw/day
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
ca. 15 mg/kg bw/day
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

Maternal data:
Pregnancy rates were similar between the groups. No
mortality occurred in the control or treated groups during
d6-20. Terminal body weight and body weight gain (d6-20) was
comparable between control, low-  and mid-dose females, but
sign. reduced in high-dose females (71 g versus 118 g of
controls). Several high-dose females were reported to have
pale eye color during dosing interval. Comparable between
control, low-  mid- and high-dose groups were the mean
numbers of implantations (13.3,13.9,14.1,13.6), but mean
number of resorptions were sign. increased in the high-dose
group: 5.6 versus 0.5 in controls and mean number of live
fetuses were significant decreased (8.0 versus 12.8 in
controls) in this dose-group, 7/22 high-dose females (31.8%)
had uterine implantation sites comprised entirely  of
resorption sites. 
Maternal gross postmortem observations: mean spleen weights
sign. higher than control in each treated group, mean spleen
to body weight ratio higher in all treated groups, sign. in
the mid- and high-dose group (dose-related increase), from
low-dose onwards significant  dose-dependent lesions of the
spleen: enlargement (up to 4 x normal size in high-dosed
females), dark coloration and/or pitted surface.
Fetal data: 
The mean number of male and female fetuses and mean fetal
weights were comparable between the control, low- and
mid-dose groups. In the high dose group, the mean number of
male and female fetuses (male: 4.2 versus 6.2 in control,
female 3.8 versus 5.5 in contr.) and the respective mean
weights (male: 3.33 g versus 3.95 g, female: 3.11 g versus
3.76 g in contr.) were markedly lowered. In this dose-group
the incidence of ossification variations (i.e.,
assymetrical/unossified sternebrae, incompletely ossified
cervical vertebral transverse processes, rudimentary
structures) was sign. increased when compared to controls
(95.7 % versus 85.5 % in contr.). 
Fetal evaluations at low- and mid-dose levels did not reveal
a teratogenic response. At high-dose level, a significant
increase in the incidence of skeletal malformations (30.4 %
versus 1.3 % in controls), predominantly angulated ribs
alone or associated with misshapen and/or shortend bones of
the forelimbs (i.e. humerus, radius, ulna) was noted.

Applicant's summary and conclusion

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