Isopropyl benzoate

Endpoint summary

Description of key information

Isopropyl benzoate is not acutely toxic to rats by the oral, dermal or inhalation routes of exposure.

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

Study period:

April 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline method according to GLP, documentation is incomplete.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Remarks:

Principles of GLP, UK GLP methods

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

male/female

Route of administration:

oral: drinking water

Vehicle:

water

Remarks:

DI water

Details on oral exposure:

VEHICLE: Water
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/Kg

Doses:

Single dose 2000 mg/KG

No. of animals per sex per dose:

Five male and five female rats

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Every day for 14 days
- Other examinations performed: clinical signs, body weight and any other signs of toxicity observed and recorded. AT the end of the study the animals were killed and macroscopically examined post mortem.

Preliminary study:

There were no deaths and no significant signs of toxicity. Acute oral median dose is in excess of 2000 mg /Kg

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No

Clinical signs:

other: No clinical toxicity signs were observed

Other findings:

- Other observations: No deaths, toxicity or significant findings at post mortem.

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Acute oral LD50 dose of IPB is in excess of 2000 mg /kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

adequate

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Experimental studies were performed in a reliable research institute prior to establishment of international guidelines and GLP

Qualifier:

no guideline available

Principles of method if other than guideline:

Precedes establishment of guideline and GLP. It is assumed that this scientific study was performed according to the accepted standards of its day

GLP compliance:

no

Remarks:

Precedes establishment of GLP

Test type:

standard acute method

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

inhalation: vapour

Type of inhalation exposure:

not specified

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Concentrations:

saturated vapour

Details on study design:

Minimal data is available on this 1951 study. The maximum concentration was described qualitatively as "saturated vapour" and the amount of time elapsed before death was observed in any animal was reported. The type of exposure is most likely whole body, but is not specifically described. After exposure, animals were observed and mortality assessed for 14 days.

Sex:

not specified

Dose descriptor:

LC0

Effect level:

other: described qualitatively as "saturated vapour"

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: No deaths occurred in rats after 4 h of inhalation exposure to saturated vapour

Conclusions:

No deaths occurred in rats after 4 h of inhalation exposure to saturated vapour of isopropyl benzoate

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

adequate

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP, however, documentation is incomplete.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

male/female

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Duration of exposure:

single 24 hour dermal application.

Doses:

2000mg/kg of lsopropyl Benzoate

No. of animals per sex per dose:

Five male and five female rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily
- Other examinations performed: clinical signs, body weight: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No

Clinical signs:

other: Signs of slight skin irritation had fully regressed by day 14, with the exception of one animal, which had scabs at the edge of treatment site at day 15. There was no significant finding at postmortum observation.

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal median lethal dose was estimated to be in excess of 2000 mg/Kg to male and female rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

adequate

Additional information

The LD50 values in rats for isopropyl benzoate by the oral and dermal routes of administration are greater than 2000 mg/kg bw. The saturated vapour of isopropyl benzoate resulted in no lethality in exposed rats.

Justification for selection of acute toxicity – oral endpoint
experimental data

Justification for selection of acute toxicity – inhalation endpoint
experimental data; qualitative

Justification for selection of acute toxicity – dermal endpoint
experimental data

Justification for classification or non-classification

The LD50 values in rats for isopropyl benzoate by the oral and dermal routes of administration are greater than 2000 mg/kg bw and so do not meet the criteria for classification for acute toxicity in Regulation EC No. 1272/2008. The substance is not considered acutely toxic to rats by the inhalation route.