Benzoic acid, 2-[[(4-hydroxyphenyl)sulfonyl]oxy]-, methyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 April to 9 May 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Data have been generated according to current internationally recognised study guidelines and in accordance with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

methyl 2-[(4-hydroxybenzenesulfonyl)oxy]benzoate

Cas Number:

1432505-97-9

Molecular formula:

C14H12O6S

IUPAC Name:

methyl 2-[(4-hydroxybenzenesulfonyl)oxy]benzoate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

other: CRL:(WI)

Sex:

female

Details on test animals or test system and environmental conditions:

Species and strain: CRL:(WI) rats
Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
Hygienic level at arrival: SPF
Hygienic level during
the study: Standard housing conditions
Number of animals: 6 animals, 3 animals/group
Sex: Female, nulliparous and non-pregnant.
Age of animals at dosing: Young healthy adult rats, 9 weeks old
Body weight at treatment: 193 – 203 g
Acclimation period: At least 5 days
Animal health: Only healthy animals were used for the test. The veterinarian certified health status.
Number of animal room: 522/6
Housing: 3 animals / cage
Cage type: Type II polypropylene/polycarbonate
Bedding: Lignocel Bedding for Laboratory Animals was available to animals during the study.
A copy of the Certificate of Analysis is retained in the archive at CiToxLAB Hungary Ltd.
Lighting period: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 – 70 %
Ventilation: 15 – 20 air exchanges/hour
Enrichment: Animals were housed by group to allow social interaction and with deep wood sawdust bedding to allow digging and other normal rodent activities.
Animals received ssniff® SM R/M-Z+H "Autoclavable complete diet for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany ad libitum, and tap water from the municipal supply, as for human consumption from 500 ml bottle ad libitum. The food is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Doses:

concentration of 200 mg/mL at a dosing volume of 10 mL/kg bw

No. of animals per sex per dose:

3 female

Control animals:

no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: None

Gross pathology:

There was no evidence of the macroscopic observations at a dose level of 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 is >2000 mg/kg bodyweight.

Executive summary:

The acute oral toxicity was assessed by gavage dosing to female CDR:(WI) rats at a dose level of 2000 mg/kg bodyweight according to the OECD 423 test guideline and in compliance with GLP. No mortality, effects to bodyweight or clinical signs were observed and the LD50 is >2000 mg/kg bodyweight