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Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from study report

Data source

Reference
Reference Type:
other: Secondary Literature
Title:
Chronic Feed Study of the test chemical
Author:
Environmental Protection Agency (EPA)
Year:
2003
Bibliographic source:
EPA_61788441_2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Refer below principle
Principles of method if other than guideline:
90 day oral feeding study in rats was conducted to determine the toxic nature of the test chemical.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Phenol, styrenated
EC Number:
262-975-0
EC Name:
Phenol, styrenated
Cas Number:
61788-44-1
Molecular formula:
C88H88O4
IUPAC Name:
Phenol, styrenated
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Phenol, styrenated
- Substance type: Organic
- Physical state: Liquid

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
No details available

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
36 Weeks
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
Five levels ranging from 5 to 500 mg/kg/day
Basis:
no data
No. of animals per sex per dose:
No data available
Control animals:
yes, concurrent vehicle
Details on study design:
No data
Positive control:
No data

Examinations

Observations and examinations performed and frequency:
Body weight:Yes
Organ weight:Yes
Organ examined-Liver weight
Sacrifice and pathology:
HISTOPATHOLOGY: Yes
Biochemical examination:Yes
Other examinations:
No data
Statistics:
No data

Results and discussion

Results of examinations

Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Statistically lower body weights at 158 and 500 mg/kg/day (body weight gain not reported). Report states that growth was depressed only at 500 mg/kg/day.
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
Increased liver and kidney weights relative to body weight (no absolute organ weights reported).
Gross pathological findings:
not specified
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
No histopathology and clinical pathology examinations were conducted.
Histopathological findings: neoplastic:
not specified
Other effects:
not specified

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
150 other: mg/kg-bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No adverse effects observed in histopathological and biochemical examinations,body weght and organ weight.
Dose descriptor:
LOAEL
Effect level:
500 other: mg/kg-bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Effect : growth depressed,incresed liver and kidney weight.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The chronic repeated dose toxicity NOAEL( No observed adverse effect level) and LOAEL (Lowest observed adverse effect level) of the test chemical to male/female rats by oral (feed) route was observed at a dose concentration of 150 mg/kg bw/day and 500 mg/kg bw/day respectively in a 36 weeks study period where the dosage of the test chemical was daily given to rats orally.

Executive summary:

Repeated dose oral toxicity study was conducted to determine the toxic nature of the test chemical. The study was performed using male and female rats for 36 weeks. During the study, the animals were observed for clinical signs, mortality, body weight changes, gross pathology. Statistically lower body weights at 158 and 500 mg/kg/day (body weight gain not reported). Report states that growth was depressed only at 500 mg/kg/day.  Increased liver and kidney weights relative to body weight. The chronic repeated dose toxicity NOAEL( No observed adverse effect level) and LOAEL (Lowest observed adverse effect level) of Phenol, styrenated to male/female rats by oral (feed) route was observed at a dose concentration of 150 mg/kg bw/day and 500 mg/kg bw/day in a 36 weeks study period where the dosage of the test chemical was daily given to rats orally.