Bis(4-chlorophenyl) sulphone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to OECD guideline with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

(analytical purity not reported)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(4-chlorophenyl) sulphone

EC Number:

201-247-9

EC Name:

Bis(4-chlorophenyl) sulphone

Cas Number:

80-07-9

Molecular formula:

C12H8Cl2O2S

IUPAC Name:

1-chloro-4-(4-chlorobenzenesulfonyl)benzene

Details on test material:

- Name of test material: 4,4'-dichlorodiphenyl sulfone (DCDPS)
- Physical state: solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Herilan Mrh-Haltung, H. Eggermann KG
- Mean body weight at study initiation: males 193 g (190-200 g) females 153 g (150-160 g)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
Concentration in vehicle: 50 %

DOSE VOLUME APPLIED:
7.67 mL/kg bw (3830 mg/kg bw)
10.0 mL/kg bw (5000 mg/kg bw)
13.62 mL/kg bw (6810 mg/kg bw)

Doses:

3830, 5000 and 6810 mg/kg bw

No. of animals per sex per dose:

5 animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several times on the day of application and daily thereafter. Body weights were recorded on days 2-4, 7 and 13 post application.
- Necropsy of all survivors was performed.

Statistics:

Finney DJ (1971). Probit analysis (3rd edition). Cambridge University Press, Cambridge, UK.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 189 mg/kg bw

Based on:

test mat.

95% CL:

4 376 - 6 303

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

5 400 mg/kg bw

Based on:

test mat.

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

4 810 mg/kg bw

Based on:

test mat.

Mortality:

Mortality incidences for male (m) and female (f) rats were:
3830 mg/kg bw: 0/5 (m), 2/5 (f), 2/10 (total)
5000 mg/kg bw: 1/5 (m), 2/5 (f), 3/10 (total)
6810 mg/kg bw: 5/5 (m), 4/5 (f), 9/10 (total)

Clinical signs:

other: The clinical signs observed were dyspnoea, apathy, aggressiveness, staggering, spastic gait, ruffled fur, alopecia, sticky muzzle, sticky eyes and poor condition.

Gross pathology:

Deceased animals: acute dilatation in the right auricle and hyperaemia in the heart, haemorrhagic ulceration in the stomach, pale kidneys, degenerative changes in lobes of liver (1 animal).
Sacrificed animals: no macroscopical findings.

Applicant's summary and conclusion

Executive summary:

In this acute oral toxicity study (BASF AG, 1981), Sprague-Dawley rats (5 rats/sex/dose level) were given a single oral dose (gavage) of DCDPS in olive oil (50 % a.i.) at dose levels of 3850, 5000 or 6810 mg/kg. Animals were then observed for mortality, body weight changes and clinical signs of toxicity for 14 days. All surviving animals were subjected to necropsy at the end of the treatment period.

The oral LD50 was 5189 mg/kg bw (males: 5400 mg/kg bw; females: 4810 mg/kg bw) under the conditions of this study. DCDPS is of low acute oral toxicity based on this LD50.