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Diss Factsheets

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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP; short report, early study,but adhereing to the main priciples of this type of study.

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
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
extreme dose and application volume
GLP compliance:
no
Remarks:
pre-dates GLP regulation
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-octadecyl-1H-thioxantheno[2,1,9-def]isoquinoline-1,3(2H)-dione
EC Number:
248-702-8
EC Name:
2-octadecyl-1H-thioxantheno[2,1,9-def]isoquinoline-1,3(2H)-dione
Cas Number:
27870-92-4
Molecular formula:
C36H45NO2S
IUPAC Name:
14-octadecyl-8-thia-14-azapentacyclo[10.6.2.0²,⁷.0⁹,¹⁹.0¹⁶,²⁰]icosa-1(19),2,4,6,9,11,16(20),17-octaene-13,15-dione

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
Strain: Hoe: WISKf (SPF 71)
Average weight: 164 g at gavage
Fasting: 16 hours before gavage

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25 % ( 25 ad 100 ml)

DOSE VOLUME APPLIED: 40 ml/kg
Doses:
10 000 mg/kg
No. of animals per sex per dose:
10
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD0
Effect level:
>= 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: extreme dose and application volume
Mortality:
none
Clinical signs:
other: piloerection; hunched posture at 1.25 hours after administration; yellow discolored faeces
Gross pathology:
no effect
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Single oral administration of the test material to female rats at a dose of 10000mg/kg bw did not produce mortality. The LD 50 was > 10000 mg/kg.
Executive summary:

Ten female Wistar rats were once treated with a dose of 10000 mg/kg bw at an application volume of 40 ml/kg in sesame oil via gavage.

None of the animals died. Animals showed piloerection, hunched posture and yellow discolored faeces shortly after administration. No effects were noted at necropsy after 14 days of observation.

The LD 50 was > 10000 mg/kg.