Benzenesulfonic acid, 4-hydroxy-, 2,6-dimethylphenyl 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:

2,6-dimethylphenyl 4-hydroxybenzene-1-sulfonate

Cas Number:

1364731-90-7

Molecular formula:

C14H14O4S

IUPAC Name:

2,6-dimethylphenyl 4-hydroxybenzene-1-sulfonate

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: 201 – 209 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: 522/5
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.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: PEG 400

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

The substance did not cause mortality at a dose level of 2000 mg/kg bw.

Clinical signs:

other: Treatment did not cause any clinical signs during the 14 days observation period.

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