Tris(4-chlorophenyl)sulfonium 5-benzoyl-4-hydroxy- 2-methoxybenzenesulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 - 21 Jul 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted Dec 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries, 12 Nousan, Notification No. 8147, November 2000, including the most recent partial revisions

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): PM-5927
- Physical state: off-white powder
- Lot/batch No.: 04-3
- Expiration date of the lot/batch: 01 Mar 2006
- Storage condition of test material: at room temperature in the dark

Test animals

Species:

rat

Strain:

other: Wistar Crl:WI

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: 172 ± 8 (mean ± SD, group 1) and 185 ± 2 (mean ± SD, group 2)
- Fasting period before study: animals were fasted overnight for a maximum of 20 hours prior to dosing until 3-4 hours after administration of the test substance
- Housing: 3 animals per cage, in labelled Macrolon cages (MIV ; height 18 cm) containing sterilised sawdust as bedding material (Woody-Clean type 3/4; Tecnilab-BMI B.V., Someren, the Netherlands) and paper as cage-enrichment (Enviro-dri, BMI, Helmond, the Netherlands)
- Diet: standard pelleted laboratory animal diet (Altromin, code VRF 1, Lag, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6 - 22.4 (actual range)
- Humidity (%): 46 - 81 (actual range)
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: the vehicle was selected based on trial formulations performed at the test laboratory and on test substance data supplied by the sponsor

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION (if unusual): the formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of the vehicle (1.036).

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females (group 1)
3 females (group 2)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for mortality and morbidity twice daily; the occurrence of clinical signs was recorded at periodic intervals on Day 1, and once daily thereafter until Day 15; body weight was recorded on Day 1 (prior to administration), 8 and 15
- Necropsy of survivors performed: yes

Statistics:

Means and standard deviation was calculated for the body weights.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

6/6 animals had a hunched posture from 0-2 hours after dosing until Day 2. Uncoordinated movements were noted in 6/6 rats 2 hours after dosing, persisting until 4 hours after dosing in 4/6 animals.

Body weight:

No effect on body weight was noted.

Gross pathology:

No substance-related findings were noted during the necropsy and macroscopic examination.

Any other information on results incl. tables

Table 1: Mortality and clinical signs

Dose [mg/kg bw]	Toxicological results*	Duration of clinical signs	Time of death	Mortality (%)
Females
2000	0/6/6	Day 1-2	-	0
Overall LD50 > 2000 mg/kg bw

* first number = number of dead animals                            

 second number = number of animals with systemic clinical signs             

 third number = number of animals used                           

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified