Perylene-3,4:9,10-tetracarboxylic dianhydride

Acute Toxicity: oral

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:

1976

Report date:

1976

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. A test group consisting of 5 animals/sex 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 were also subjected to necropsy.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Perylene-3,4:9,10-tetracarboxylic dianhydride

EC Number:

204-905-3

EC Name:

Perylene-3,4:9,10-tetracarboxylic dianhydride

Cas Number:

128-69-8

Molecular formula:

C24H8O6

IUPAC Name:

7,18-dioxaheptacyclo[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.

Specific details on test material used for the study:

- Physical state: solid

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 weights males: 220 g, females: 170 g
- Diet (e.g. ad libitum): Altromin R 1324, Altromin GmbH, Lage

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5% aequous solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 35% w/v

Doses:

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:

no mortality was reported

Clinical signs:

other: dyspnea, apathy, red skin, red feces, general bad condition. All animals recovered after 4 days.

Gross pathology:

no deviations from normal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions chosen, no exposed animal died during the study and thus, the LD50 was concluded to be greater than 10000 mg/kg bw.

Executive summary:

In an acute oral toxicity study comparable to OECD guideline 401, Sprague-Dawley rats (5/sex/dose) were administered the test substance 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 dyspnea, apathy, bad general health, red coloring of the skin and of the feces. The animals recovered within 2 days. No abnormal findings were made at necropsy. The LD50 was >10000 mg/kg bw.