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Description of key information

Repeated dose toxicity: Oral

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 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 in a 36 weeks study period where the dosage of the test chemical was daily given to rats orally.

Repeated dose toxicity: Inhalation

Phenol styrenated (CAS no 61788-44-1) has very low vapor pressure of 0.00075 mmHg at 20°C. So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated dose toxicity by inhalation route is considered for waiver.

Repeated dose toxicity: Dermal

The acute dermal toxicity value for Phenol, styrenated (as provided in section 7.2.3) is >2000 mg/kg body weight. Thus, it is expected that Phenol, styrenated shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that Phenol, styrenated shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
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
Qualifier:
according to
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
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
No details available
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
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
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
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
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.
Critical effects observed:
not specified
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 Phenol, styrenated was daily given to rats orally.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
150 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Data is from secondary source

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: inhalation, other
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
Waiver

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: dermal
Data waiving:
other justification
Justification for data waiving:
other:
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
Waiver

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Data available for the target chemical and its read across chemical was reviewed to determine the toxic nature of the test chemical. The studies are as mentioned below:

Repeated dose toxicity: Oral

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 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 in a 36 weeks study period where the dosage of the test chemical was daily given to rats orally.

Sunchronic repeated dose oral toxicity study was performed to determine the toxic nature of the test chemical. The study was performed using male and female rats for 90 days. During the study, the animals were observed for clinical signs, mortlaity, body weight and organ weight changes, gross pathology and histopathology. The subchronic repeated dose toxicity NOAEL ( No observed adverse effect level) and LOAEL (Lowest observed adverse effect level) of the test chemical to 30 male/female rats by oral (feed) route was observed at a dose concentration of 50 mg/kg bw/day and 158 mg/kg bw/day in a 90 days study period where the dosage of the test chemical was daily given to rats orally. At a dose concentration 158 mg/kg bw/day, some effects was noted such as body weight gain were significantly lower than controls. Liver weights relative to body weights were higher than controls. But these effects was not considered to be the adverse one thus it is concluded that the test substance is non toxic by repeated dose exposure. Based on the above, it can be concluded that the test chemical is unlikely to be toxic in nature via repeated dose oral route to rats.

Repeated dose oral toxicity study was performed to determine the toxic nature of the test chemical. The study was performed for 3 months using male and female F344/N rats. The test chemical was dissolved in corn oil and used at dose level of 0, 37.5, 75, 150, 300, or 600 mg/kg. Concurrent solvent control chemicals were also included in the study. All rats survived to the end of the study except one 600 mg/kg male and one 37.5 mg/kg female that were killed in dosing accidents. Mean body weights of all exposed groups of males were significantly less than that of the vehicle control group; however, only the decrease for the 600 mg/kg group exceeded 10% and was considered related to the test chemical exposure. Liver weights were significantly increased in 300 and 600 mg/kg females. The incidences of minimal atrophy of the olfactory epithelium of the nose were significantly increased in 150 mg/kg or greater males and in 300 or 600 mg/kg females. The incidence of atrophy of olfactory nerve bundles was significantly increased in 600 mg/kg females. Minimal to mild periportal hepatocellular cytoplasmic alteration occurred in all 300 or600 mg/kg females. Based on the observations made, the no observed adverse effect level (NOAEL) for the test chemical is considered to be 75 mg/Kg/day.

Repeated dose toxicity: Inhalation

Phenol styrenated (CAS no 61788-44-1) has very low vapor pressure of 0.00075 mmHg at 20°C. So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated dose toxicity by inhalation route is considered for waiver.

Repeated dose toxicity: Dermal

The acute dermal toxicity value for Phenol, styrenated (as provided in section 7.2.3) is >2000 mg/kg body weight. Thus, it is expected that Phenol, styrenated shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that Phenol, styrenated shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.

Based on the data available for the test chemicals and applying the weight of evidence approach, the test chemical does not exhibit toxic nature upon repeated exposure by oral route of administration. Hence the test chemical is likely to be non toxic as per the criteria mentioned in CLP regulation.

Justification for classification or non-classification

Based on the data available for the test chemicals and applying the weight of evidence approach, the test chemical does not exhibit toxic nature upon repeated exposure by oral route of administration. Hence the test chemical is likely to be non toxic as per the criteria mentioned in CLP regulation.