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Description of key information

LD50 was considered to be 2800 mg/kg when Osborne-Mendel male and female rats were treated with hydratropic aldehyde (2-phenylpropanal) orally. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed journal
Qualifier:
according to
Guideline:
other: as below
Principles of method if other than guideline:
Acute oral toxicity study was carried out in Osborne- Mendel rats.
GLP compliance:
not specified
Test type:
other: no data
Species:
rat
Strain:
Osborne-Mendel
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
Source: No Data
Age at study initiation: No Data
Weight at study initiation: No Data
Fasting period before study: Rats were fasted approximately 18 hours prior to treatment
Housing: Cages
Diet (e.g. ad libitum): Food was replaced as soon rats were dosed and was available ad libitum
Water (e.g. ad libitum): Water. Ad libitum
Acclimation period: No Data
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
MAXIMUM DOSE VOLUME APPLIED: 3500 mg/kg
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
Duration of observation period following administration: The rats were observed for toxic signs for 2 weeks
Frequency of observations and weighing: Daily
Necropsy of survivors performed: No data
Statistics:
The LD50 was computed by the method of Litchfield & Wilcoxon (1949)
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 800 mg/kg bw
Based on:
test mat.
95% CL:
2 390 - 3 280
Mortality:
Death time – 1 – 4 days and Coma within 20 minutes after treatment
Clinical signs:
Rough fur was observed in the treated rats
Body weight:
No data
Gross pathology:
No data
Other findings:
No data
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral study in rats, the acute oral LD50 for Hydratrophic aldehyde (2 Phenyl propanal) was determined to be 2800 (2390 - 3280) mg/kg
Executive summary:

Acute Oral study was carried out in rats.

Groups of 10 young adult Osborne- Mendel rats evenly divided by sex were fasted for approximately 18 hours prior to treatment. Animals had access to water at all times, All doses were given by intubation.

All animals were maintained under close observation for recording toxic signs and death time. Such observations continued until animals appeared normal and showed weight gain. The observation period was 2 weeks.

THE LD50 were computed by the method of Litchfield and Wilcoxon(1949)

Death time was 1 – 4 days and Coma within 20 minutes after treatment was observed.

The acute oral LD50 for Hydratrophic aldehyde (2 Phenyl propanal) was found to be 2800 (2390 - 3280) mg/kg

According to the CLP regulation the substance was not classified.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 800 mg/kg bw
Quality of whole database:
Data is kimish 2 and from peer reviwed journal

Additional information

Acute oral:

Toxicity of hydratropic aldehyde (2-phenylpropanal) was summarised as below

In a study conducted by Jenneret al. (1964), acute oral toxicity was evaluated in Osborne-Mendel male and female rats by using hydratropic aldehyde (2-phenylpropanal) in the concentration of 2800 mg/kg (with the 95 % confidence limit of 2390-3830 mg/kg) orally by gavage. Coma within 20 min and rough fur were observed in treated rats. In addition, deaths were observed in 1-4 days after treatment at 2800 mg/kg dose. Therefore, LD50 was considered to be 2800 mg/kg when Osborne-Mendel male and female rats were treated with hydratropic aldehyde (2-phenylpropanal) orally.

In a study conducted by Sipeset al. (2006), acute oral toxicity was evaluated in male and female rats by using hydratropic aldehyde (2-phenylpropanal) in the concentration of 3650 mg/kg orally. LD50 was considered to be 3650 mg/kg when male and female rats were treated with hydratropic aldehyde (2-phenylpropanal) orally.

In a study conducted by Sipeset al. (2006), acute oral toxicity was evaluated in rats by using hydratropic aldehyde (2-phenylpropanal) in the concentration of 2800 mg/kg orally. LD50 was considered to be 2800 mg/kg when male and female rats were treated with hydratropic aldehyde (2-phenylpropanal) orally.

Thus, based on the above studies, hydratropic aldehyde (2-phenylpropanal) (CAS no 93-53-8) non toxic > 2800 mg/kg bw as per the CLP classification likely to be non hazardous by oral route.


Justification for selection of acute toxicity – oral endpoint
LD50 was considered to be 2800 mg/kg when Osborne-Mendel male and female rats were treated with hydratropic aldehyde (2-phenylpropanal) orally.

Justification for classification or non-classification

Hydratropic aldehyde (2-phenylpropanal) (CAS no 93-53-8) as per the CLP classification likely to be non hazardous by oral route.