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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2020
Report date:
2020

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
December 17, 2001
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N,Nā€™-di[3-(p-toluene sulfonyl)oxy]phenyl urea
EC Number:
876-151-9
Cas Number:
2292123-68-1
Molecular formula:
C27H24N2O7S2
IUPAC Name:
N,Nā€™-di[3-(p-toluene sulfonyl)oxy]phenyl urea
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Remarks:
Crl:CD(SD)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CRL, Japan
- Females: yes
- Age at study initiation: 8 weeks
- Weight at study initiation: 200.1g (sighting study); 194.8 - 210.7g (main study)
- Fasting period before study: 17 - 19 hours
- Housing: hanging stainless steel cages with mesh floors; barrier-system animal rooms
- Historical data:
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
- Method of randomisation in assigning animals to test and control groups: not stated

ENVIRONMENTAL CONDITIONS
- Temperature (Ā°C): 21 - 25Ā°CĀ 
- Humidity (%): 40 - 70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12hrs dark / 12hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Remarks:
The substance was suspended in olive oil at a concentration of 20% (w/v)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20% (w/v)
- Amount of vehicle (if gavage): 20mL
- Justification for choice of vehicle: the test substance would not dissolve in purified water. Vehicle is commonly used in general toxicity studies

DOSAGE VOLUME: 10 mL/kg
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
sighting study: 1 female/dose
main study: 4 female/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed continuously for 10 minutes after administration, then 30 minutes, then 3 hours. From Day 1 to Day 14 the animals were observed once each morning.
- Necropsy of survivors performed: yes
- Clinical signs including body weight: yes
- Other examinations performed: gross necropsy. External surfaces of the body, all orifices, subcutis, cranial, thoracic, abdominal and pelvic cavities with their contents were observed.
Statistics:
None

Results and discussion

Preliminary study:
No evidence of toxicity or mortality was observed in the sighting study.
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
other:
Body weight:
lower than 10% body weight loss
Remarks:
No body weight loss was observed. See Table 4 below
Gross pathology:
No treatment-related effects observed.

Any other information on results incl. tables

Table 3: Clinical signs


















































































































































   StudyDose (mg/kg)    Animal no.   Day after administration  
01234567891011121314
(min)(hr)
0a)-55-10303
Sighting20001---MS--------------
Main2------------------
3------------------
4------------------
5------------------

a) immediately after dose administration 


- no abnormalities detected


MS: mucous stool


Table 4: Body weight


























































StudyDose (mg/kg)Animal No.Body weight (g)
Day after administration
initial1a)7a)14a)
Sighting20001200.1

226.8


(26.7)


251.2 (24.4)265.1 (13.9)
Main2195.1

213.5


(18.4)


239.7 (26.2)253.0 (13.3)
3194.8213.8 (19.0)239.7 (25.9)258.0 (18.3)
4199.7218.5 (18.8)221.3 (2.8)250.5 (29.2)
5210.7234.8 (24.1)254.9 (20.1)280.4 (25.5)

a) figues in parentheses indicate difference from previous body weight


Table 5: Historical data: Frequency of mucous stool after administration of olive oil to starved Crl:CD (SD)















SignSexNo. of occurances/no. of dosed animals
Mucous stoolFemale38/135

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No mortality or treatment-related effects were observed during the study. The LD50 value was determined to be >2000 mg/kg.