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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant study, similar to test guideline OECD 401.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: OECD 401
Deviations:
yes
Remarks:
(i.p. administration, 7-days observation period, no necropsies)
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
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'-dichlorodiphenylsulfone (DCDPS)
- Physical state: white powder
- Storage condition: at room temperature, protected from light
- Test item sample received on 02-Jan-1989

Test animals

Species:
mouse
Strain:
ICR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Sprague Dawley Inc, Frederick, MD, USA
- Age at study initiation: 6-8 weeks old
- Weight at study initiation: males 27-37 g, females 22-28 g
- Housing: in groups of max. 5 animals/cage, in autoclavable plastic cages with filter tops
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 74 ±6 °F (23.3 ± 3.4 °C)
- Humidity: 50 ± 20 %
- Photoperiod: 12 hours dark / 12 hours light

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
corn oil
Details on exposure:
Single intraperitoneal injection
Doses:
500, 1000, 1500, 2000, 2500 or 5000 mg/kg bw
No. of animals per sex per dose:
5 animals
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 7 days
- Weighing: once prior to dosing and on days 1 and 3
- Necropsy of survivors performed: no
Statistics:
Probit analysis

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 448 mg/kg bw
Based on:
test mat.
Mortality:
The mortality incidences noted in males (m) and females (f) during the 7-days observation period were as follows:
0/5 (m), 0/5 (f) in controls and at 500 and 1000 mg/kg bw
1/5 (m), 2/5 (f) at 1500 mg/kg bw
3/4 (m), 2/5 (f) at 2000 mg/kg bw
5/5 (m), 4/5 (f) at 2500 mg/kg bw
4/5 (m), 4/5 (f) at 5000 mg/kg bw
Clinical signs:
Head tilt, running in circles, lethargy, piloerection, hunched posture and/or cloudy eyes were noted at 1500 mg/kg bw and/or at higher dose levels.
Body weight:
In treated mice, dose-dependent decreases in body weight were noted as compared to pre-treatment body weights.
Gross pathology:
Not determined

Applicant's summary and conclusion

Executive summary:

This acute toxicity study (Microbiological Associates Inc., 1991) was performed as a preliminary test in order to set dose levels for a micronucleus test (see section 7.6.2).

Young adult ICR mice (5 mice/sex/dose level) were treated by intraperitoneal injection of DCDPS in corn oil at dose levels of 0 (vehicle control), 500, 1000, 1500, 2000, 2500 or 5000 mg/kg bw. Dose-dependant mortality was noted in both sexes at 1500 to 5000 mg/kg bw during the 7 -days observation period. Male and female animals treated at 1500 mg/kg bw or higher dose levels showed head tilt, running in circles, lethargy, piloerection, hunched posture and or cloudy eyes. Dose-dependent decreases in body weight were noted in treated mice as compared to pre-treatment body weights.

The LD50 value for the intraperitoneal route was 2448 mg/kg bw. Based on this LD50 value, DCDPS dislays low acute toxicity following intraperitoneal exposure.