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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only short abstract available and original reference not translated (Japanese)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Guideline for 28-Day Repeated Dose Toxicity Test In Mammalian Species (Chemical Substances Control Law of Japan)
Deviations:
yes
Remarks:
method shortly described
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-chlorophenol
EC Number:
203-402-6
EC Name:
4-chlorophenol
Cas Number:
106-48-9
Molecular formula:
C6H5ClO
IUPAC Name:
4-chlorophenol
Details on test material:
- Name of test material (as cited in study report): 4-chlorophenol
- Analytical purity: 99.29%

Test animals

Species:
rat
Strain:
other: Crj:CD(SD)IGS
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
28 days
Frequency of treatment:
once daily, 7 days/week
Doses / concentrations
Remarks:
Doses / Concentrations:
20, 100, 500 mg/kg/day
Basis:
actual ingested
No. of animals per sex per dose:
6 or 12 (control, 500 mg/kg bw)
Control animals:
yes, concurrent vehicle

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
500 mg/kg bw (male and female): tremor, tachypnea, and salivation
Mortality:
mortality observed, treatment-related
Description (incidence):
500 mg/kg bw (male and female): tremor, tachypnea, and salivation
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Haematological findings:
effects observed, treatment-related
Description (incidence and severity):
500 mg/kg bw (males): increase in leukocytes
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
effects observed, treatment-related
Description (incidence and severity):
100 mg/kg bw/day(males) and 500 mg/kg bw /day (males and females): increase or an increasing trend for urine volume; 100 mg/kg bw /day (males): decreases in osmotic pressure and specific gravity; 500 mg/kg bw (males): decreasing trend for osmotic pressure
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Details on results:
URINALYSIS: marked occult blood in the urine and appearence of erythrocytes in the urinary sediment

Effect levels

open allclose all
Dose descriptor:
NOEL
Effect level:
20 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: Based on results on urinalysis male rats
Dose descriptor:
NOEL
Effect level:
100 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
female
Basis for effect level:
other: Based on results on urinalysis and hematology in male and female rats

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion