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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
analytical purity of the test substance not reported, weekly body weight was not determined, necropsy was not performed on the deceased or surviving animals
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 (as cited in study report): 4,4-Dioxydiphenylsulfon
- Physical state: solid
- Analytical purity: not reported

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: ca. 9 weeks
- Mean body weight at study initiation: 181 g
- Diet (e.g. ad libitum): Altromin R (Altromin GmbH, Lange)
- Water (e.g. ad libitum): Tap water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1.5
- Humidity (%): 60±5
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Lutrol
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 20 ml/kg bw

DOSAGE PREPARATION: The test substance was dissolved in Lutrol by stirring on a magnetic-stirrer at room temperature.
Doses:
1000, 1500, 2000, 3100, 3500, 4000, 5000, 5500 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
The animals were checked for mortality or toxic effects twice daily on weekdays and once daily on weekends or holidays.
The body weight of the animals was determined prior to substance administration and at the end of the 14-days observation period.
- Necropsy of survivors performed: no
Statistics:
Calculation of LD50 was performed with probit analysis (Fink and Hund, Arzneim.-Forsch. 15: 624, 1965).

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
2 830 mg/kg bw
Based on:
test mat.
95% CL:
2 380 - 3 270
Mortality:
see table below
Clinical signs:
The symptoms observed in all dose groups were increased diuresis, salivation, sedation, dyspnoea, lateral and prone position, decreased bw-gain, and decreased general condition.
Body weight:
All rats at all dosage levels gained weight during the 14-day observation period, though final bw were decreased in treated animals (see above).
Gross pathology:
not done

Any other information on results incl. tables

Dose (mg/kg bw)

Mortalities

Time of death

1000

0/10

-

1500

1/10

2d

2000

2/10

2d

3100

4/10

3h-7d

3500

7/10

2d

4000

9/10

2d

5000

9/10

3h-2d

5500

10/10

3h-3d

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 (oral, rat) was determined to be 2830 mg/kg bw.
Executive summary:

In a study, comparable to OECD 401 (analytical purity of the test substance not reported, weekly body weight was not determined, necropsy was not performed on the deceased or surviving animals), groups of 10 male rats per dose were administered with 1000, 1500, 2000, 3100, 3500, 4000, 5000, 5500 mg/kg bw of test substance dissolved in lutrol in a volume of 20 ml/kg bw. The animals were observed for 14 days post administration.

Dose related mortalities were observed. The clinical signs were increased diuresis, salivation, sedation, dyspnoea, lateral and prone position, decreased bw-gain, and bad general condition. The acute LD50 of the test substance was found to be 2830 mg/kg bw.

Based on test results the test substance is non toxic according to EU classification (DSD and GHS).