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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Repeated dose toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
repeated dose toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
other information
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Referenceopen allclose all

Title:
No information
Author:
Horstman, M.G. et al.: The Toxicologist 11, 87 (1991) |(abstr.)
Title:
No information
Author:
NTP, Technical Report Series No. 33, NIH Publication|93-3382, July/1993
Title:
No information
Author:
Travlos G.S. et al., Fundam. Appl. Toxicol. 30, 75-92 (1996)

Materials and methods

GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
- Name of test material (as cited in study report): 1-chloro-2-nitrobenzene
- Analytical purity: 99 %

Test animals

Species:
rat
Strain:
other: F344/N
Sex:
male/female

Administration / exposure

Route of administration:
inhalation
Duration of treatment / exposure:
13 w
Frequency of treatment:
6 h/d, 5 d/w
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 1.1, 2.3, 4.5, 9 or 18 ppm (approx. 0, 7, 14.7, 28.8, 57.6, 115.2 mg/m³)
Basis:

Control animals:
yes
Details on study design:
Post-exposure period: no

Results and discussion

Effect levels

Dose descriptor:
LOAEC
Effect level:
ca. 1.1 ppm
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

clinical signs:
no clear signs of toxicity (no other information), 
no deaths, no differences in body weight gain or terminal
body weight compared to controls;
haematology, male and female: 
concentration-related increase in methaemoglobinaemia (m
sign: from 1.1 ppm at d23; from 2.3 ppm at all time points
with max of 1.14 g/dl at 18 ppm; f sign.: from 1.1 ppm at
week 13 and from 2.3 ppm at all time points with max of 1.04
g/dl at 18 ppm), reticulocyte count (sign. at all dose
groups at week 13), nucleated erythrocytes, leucocyte count
(predominantly at the highest dose groups of male and
females);   concentration-related decrease in haematocrit,
haemoglobin, RBC (m. sign.: 1.1 ppm(d23), 4.4 ppm
(week13), 9 ppm (d4,week13),18 ppm (at all time points); f.
sign.: at every dose group at week13), MCH and MCHC (only in
females)
clinical chemistry, male and female:
increase in serum activities of sorbitol dehydrogenase and
alanine aminotransferase in different male and female
exposure groups at various time points, decrease in alkaline
phosphatase 
pathology: dark spleen (1 female, 2 males, 18 ppm) 
concentration-related increases in liver, spleen and right
kidney weight
Histopathologic changes:
liver: basophilia of centrilobular hepatocytes, kidney:
pigmentation and regeneration of the proximal convoluted
tubules, spleenic congestion was observed in all exposed and
control rats: in males with dose-dependent increase in
severity and in females with dose-dependent increase in
incidences; nose: hyperplasia of the nasal cavity
respiratory epithelium

Applicant's summary and conclusion