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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
Study period:
06.04.1982 - 20.04.1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,9-bis(3,5-dimethylphenyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone
EC Number:
225-590-9
EC Name:
2,9-bis(3,5-dimethylphenyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone
Cas Number:
4948-15-6
Molecular formula:
C40H26N2O4
IUPAC Name:
2,9-bis(3,5-dimethylphenyl)isoquino[4',5',6':6,5,10]anthra[2,1,9-def]isoquinoline-1,3,8,10(2H,9H)-tetrone
Details on test material:
Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Stamm:Hoe WISKf(SPF71); Eigenzucht
- Weight at study initiation: 201.2 g
- Fasting period before study: 16 h
- Housing: in groups in plastic cages with soft wooden granules
- Diet (e.g. ad libitum): ALTROMIN 1324 (Altromin GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25% (25 g/100 mL)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
None of the animals died during the observation period.
Clinical signs:
other: No abnormal observations. The pigment was excreted via the faeces.
Gross pathology:
No abnormal findings.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 was determined to be greater than 5000 mg/kg bw.
Executive summary:

In this acute oral toxicity study comparable to OECD guideline 401, ten female Wistar rats were exposed to the test material (25 % in sesame oil) via gavage at a final dose of 5000 mg/kg bw. No control animals were used.  During the obervation period of 14 days no mortality or abnormal clinical signs were found. The test material was excreted via the feces. Additionally no effects on body weight gain nor abnormals findings at necropsy could be observed. Based on the results of this study, the LD50 was determined to be greater than 5000 mg/kg bw.