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Toxicological information

Acute Toxicity: oral

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 189 mg/kg bw
Based on:
test mat.
95% CL:
4 376 - 6 303
Sex:
male
Dose descriptor:
LD50
Effect level:
5 400 mg/kg bw
Based on:
test mat.
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:
The clinical signs observed were dyspnoea, apathy, aggressiveness, staggering, spastic gait, ruffled fur, alopecia, sticky muzzle, sticky eyes and poor condition.
Body weight:
There was slight loss in body weight 2-4 days post application. The animals regained body weight 7 and 14 days post application.
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.