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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
no data
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-chloro-4-(n-propoxy)-5-thioxanthen-10-one
EC Number:
415-890-1
EC Name:
1-chloro-4-(n-propoxy)-5-thioxanthen-10-one
Cas Number:
142770-42-1
Molecular formula:
C16H13ClO2S
IUPAC Name:
1-chloro-4-propoxy-9H-thioxanthen-9-one

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River UK
- Age at study initiation: 7 weeks
- Weight at study initiation: 117-138 g
- Fasting period before study: yes
- Housing: in groups of 5 rats of the same sex
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23°C
- Humidity (%): 59%
- Air changes (per hr): 10-15%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Remarks:
CPTX was prepared at a concentration of 50% w/v in corn oil
Details on oral exposure:
volume :10 ml/kg
Administration using a syringe and plastic catheter
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily for mortality, one daily for clinical signs. bodyweight recorded on Days 1, 8 and 15.
- Necropsy of survivors performed: yes (macroscopic examination)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
none
Clinical signs:
other: Pilo-erection within 5 minutes of dosing which remainder for Day 1 in all animals but recovery completed by Day 2
Gross pathology:
No macroscopic abnormalities were observed for animals killed on Day
15.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute lethal oral dose to rats of the test item was found to be greater than 5000 mg/kg body weight.
Executive summary:

A study was performed to assess the acute oral toxicity of CPTX to the rat. A group of ten fasted rats (5 males and 5 females) was given a single dose by gavage of the test substance, formulated in corn oil, at a dose level of 5000 mg/kg bw. All animals were killed and examined macroscopically on Day 15 (the end of the observation period). There were no deaths. Clinical signs of reaction to treatment were limited to piloerection and recovery was complete by Day 2. A slightly low bodyweight gain was recorded for one male rat on Days 8 and 15. All other rats achieved anticipated bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic exmination on Day 15. The acute lethal oral dose of CPTX was found to be greated than 5000 mg/kg bw.