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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

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)
Principles of method if other than guideline:
The study was conducted according to an internal protocol which in principle is comparable to the OECD Guideline 401. Test groups consisting of 5 animals/sex/dose were treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Perylene-3,4:9,10-tetracarboxydiimide
EC Number:
201-344-6
EC Name:
Perylene-3,4:9,10-tetracarboxydiimide
Cas Number:
81-33-4
Molecular formula:
C24H10N2O4
IUPAC Name:
7,18-diazaheptacyclo[14.6.2.2²,⁵.0³,¹².0⁴,⁹.0¹³,²³.0²⁰,²⁴]hexacosa-1(23),2,4,9,11,13,15,20(24),21,25-decaene-6,8,17,19-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:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: average weight males 225 g, females 165 g
- Diet (e.g. ad libitum): HERILAN MRH-Haltung Alleinfutter, Heinrich EGGERSMANN KG Rinteln

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: water solution with 0.5% Carboxymethylcellulose- Zubereitung G/V
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% solution
- Amount of vehicle (if gavage): 20 and 13.62 ml/kg

MAXIMUM DOSE VOLUME APPLIED:
20 ml/kg
Doses:
6810 and 10000 mg/kg bw
No. of animals per sex per dose:
5
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

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 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 exposure period.
Clinical signs:
other: At the beginning dyspnea was observed. Red colored feces observed on first day. All animals recovered within two days.
Gross pathology:
No abnormal observations.

Any other information on results incl. tables

In a pretest 2 female rats per dose group were treated with dose levels of 1000 and 4640 mg/kg. No deaths occurred and no clinical symptoms were recorded except for red colored feces on the first day. No deviations from normal at autopsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was not acute toxic and thus, a LD50 greater than 10000 mg/kg bw was established.
Executive summary:

In an oral toxicity study comparable to OECD guideline 401, the test substance was administered to rats (5/sex/dose) at a single dose of 10000 mg/kg bw by gavage followed by a 14-day observation period. None of the animals died during the exposure period. Clinical signs included agonal respiration at the beginning of the observation period. No abnormal findings were made at necropsy.