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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:
other: similar to the respective guideline

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987
Reference Type:
other: short report
Title:
Unnamed
Report date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
10 male Wistar rats received single oral dose of 5000 mg/kg bw dissolved in 1% Tragant and were observed for clinical signs of intoxication, body weight development, mortaliy over a period of 14 days. At the end of the observation time all animals undergo gross pathological examination.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
8,9,10,11-tetrachloro-12H-phthaloperin-12-one
EC Number:
244-007-9
EC Name:
8,9,10,11-tetrachloro-12H-phthaloperin-12-one
Cas Number:
20749-68-2
Molecular formula:
C18H6Cl4N2O
IUPAC Name:
8,9,10,11-tetrachloro-12H-isoindolo[2,1-a]perimidin-12-one
Test material form:
other: solid
Details on test material:
IUCLID4 Test substance:
pure technical product

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation: 9 weeks
- Weight at study initiation: 180 g
- Housing: groups of 5
- Diet ad libitum
- Water ad libitum
- Acclimation period: some days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/1

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: traganth
Details on oral exposure:
10 male Wistar rats received single oral dose of 5000 mg/kg bw dissolved in 1% Tragant
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 males
Control animals:
no
Details on study design:
10 male Wistar rats received single oral dose of 5000 mg/kg bw dissolved in 1% Tragant and were observed for clinical signs of intoxication, body weight development, mortaliy over a period of 14 days. At the end of the observation time all animals undergo gross pathological examination.
Statistics:
no

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: no clinical signs, no mortality
Mortality:
0/10
Clinical signs:
no clicical signs observed
Body weight:
body weight development in the normal range
Gross pathology:
the animals sacrificed at the end of the study did not show any noticeable pathological findings.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Executive summary:

10 male Wistar rats received single oral dose of 5000 mg/kg bw dissolved in 1% Traganth and were observed for clinical signs of intoxication, body weight development, mortality over a period of 14 days. At the end of the observation time all animals undergo gross pathological examination. No animal died, no clinical signs were observed, all animals gained weight and no gross pathological findings were detected at the terminal sacrifice. Thus the LD50 is > 5000 mg/kg bw.