Isopropyl 4-hydroxybenzoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Data is from peer-reviewed journal

Data source

Reference

Reference Type:

publication

Title:

The comet assay with 8 mouse organs: results with 39 currently used food additives

Author:

Sasaki, Yu. F.; Kawaguchi, Satomi; Kamaya, Asako; Ohshita, Miyuki; Kabasawa, Kazumi; Iwama, Kayoko; Taniguchi, Kazuyuki; Tsuda, Shuji

Year:

2002

Bibliographic source:

Mutation Research; vol. 519; nb. 1-2; (2002); p. 103 - 120

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as below

Principles of method if other than guideline:

Acute oral toxicity study of isopropyl 4-hydroxybenzoate in mice to set the appropriate dose of each chemical for the comet assay

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isopropyl 4-hydroxybenzoate

EC Number:

224-069-3

EC Name:

Isopropyl 4-hydroxybenzoate

Cas Number:

4191-73-5

Molecular formula:

C10H12O3

IUPAC Name:

propan-2-yl 4-hydroxybenzoate

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): isopropyl 4-hydroxybenzoate
- Molecular formula : C10H12O3
- Molecular weight : 180.202 g/mole
- Smiles notation : c1(C(OC(C)C)=O)ccc(O)cc1
- InChl : 1S/C10H12O3/c1-7(2)13-10(12)8-3-5-9(11)6-4-8/h3-7,11H,1-2H3
- Substance type:Organic
- Physical state:Solid

Specific details on test material used for the study:

- Name of test material (as cited in study report): Isopropyl Paraben (isopropyl 4-hydroxybenzoate)
- Molecular formula (if other than submission substance): C10H12O3
- Molecular weight (if other than submission substance): 180.202 g/mole
- Substance type: Organic
- Physical state: Solid
Purity >99.0%

Test animals

Species:

mouse

Strain:

other: DDY

Sex:

male

Details on test animals or test system and environmental conditions:

Source: Japan SLC Co., Shizuoka, Japan
Age at study initiation: 8 weeks
Weight at study initiation: no data available
Fasting period before study: no data available
Housing: no data available
Diet (e.g. ad libitum): commercial pellets MF (Oriental Yeast Industries Co., Tokyo, Japan), ad libitum
Water (e.g. ad libitum): Tap Water, ad libitum
Acclimation period: 1 week of acclimatization

ENVIRONMENTAL CONDITIONS
Temperature (°C): The animal room was at 20–24°C
Humidity (%): No data
Air changes (per hr): No data
Photoperiod (hrs dark / hrs light): 12 h light–dark cycle.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

Details on exposure
VEHICLE
- Concentration in vehicle: 2000 mg/kg bw
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle:olive oil
- Lot/batch no. (if required):No data available
- Purity:No data available

MAXIMUM DOSE VOLUME APPLIED: No data available

DOSAGE PREPARATION (if unusual): Dose were prepared in olive oil

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In order to set the appropriate dose of each chemical for the comet assay, 0.5 × LD50 or the limit dose of 2000 mg/kg were given to mice.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

4-5 male mice

Control animals:

not specified

Details on study design:

- Other examinations performed: Mortality were observed.

Statistics:

not specified

Results and discussion

Preliminary study:

not specified

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality observed

Mortality:

No mortality was observed in treated male mice at 2000 mg/kg bw

Clinical signs:

other: not specified

Gross pathology:

not specified

Other findings:

not specified

Any other information on results incl. tables

Test chemical	Vehicle	Source*	LD50** mg/kg
p-Hydroxybenzoic acid iso-propyl ester	Olive oil	T	>2000

*T = Tokyo Kasei Kogyo Industry Ltd., Tokyo, Japan;

** In order to set appropriate doses for the assay, we determined approximate LD50 by simple acute toxicity experiments on four–five animals. When no death was observed at 2000 mg/kg, the LD50 was defined as >2000 mg/kg.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

LD50 was considered to be > 2000 mg/kg bw when DDY male mice were treated with isopropyl 4-hydroxybenzoate orally.

Executive summary:

In a acute oral toxicity study, DDY male mice were treated with isopropyl 4-hydroxybenzoate in the limit dose of 2000 mg/kg bw orally in Olive Oil. No mortality was observed in treated male mice at 2000 mg/kg bw. Therefore, LD50 was considered to be > 2000 mg/kg bw when DDY male mice were treated with isopropyl 4-hydroxybenzoate orally.