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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Principles of method if other than guideline:
according to internal standard method
GLP compliance:
no
Limit test:
no

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:
mouse
Strain:
other: NMRI-Wiga
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: average weight males: 28.7 g, females: 28 g

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Details on exposure:
The test substance was given as a 46.4 or 50% suspension with a 0.5% aqueous carboxymethyl cellulose solution
Doses:
10,000; 6,810; 4,640 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
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 9 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: mortality was observed
Mortality:
2/5 males and 5/5 females treated with 10,000 mg/kg, and 1/5 females treated with 6,810 mg/kg died.
Clinical signs:
Dyspnea, apathy, unsteady gait and ruffled fur were reported until day 4 in mice given 10,000 and 6,810 mg/kg. Death occurred on day 2 and 3, bad general health until and including day 4. Mice given 4640 mg/kg showed dyspnea and ruffled fur only on the first day of treatment.
Gross pathology:
Diseased animals: intra-abdominal precipitation of the substance and coloration.
Euthanized animals: intra-abdominal precipitation of the substance and coloration, thickening of the edges of the liver.

Any other information on results incl. tables

In a pretest 2 male mice per dose group were treated with dose levels of 215, 1000 and 4640 mg/kg. No deaths occurred, animals of the high and medium dose showed dyspnea and ruffled fur on the first day of treatment.

Applicant's summary and conclusion