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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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

Remarks:

only a 50% aqueous substance preparation was tested.

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 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

A 50% aqueous preparation of the mixture has been applied on the back of rabbits for 20 hours, observations were reported after 24, 48, 72 hours and after 6 and 8 days.

GLP compliance:

no

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:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2,49 kg and 2,84 kg

Test system

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

water

Controls:

no

Amount / concentration applied:

- Concentration (if solution): 50% aqueous preparation

Duration of treatment / exposure:

20 hours

Observation period:

8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: 2,5 x 2,5 cm on the backs
- Substance was applied with a cotton tissue soaked with the test article.

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with lukewarm tap water
- Time after start of exposure: 20 h after application

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 8 d

Score:

0

Max. score:

4

Remarks on result:

other: Until day 6 scoring for erythema was not possible due to the skin coloring.

Irritant / corrosive response data:

The test article did not cause apparent dermal reactions, however the exact determination of erythema scores at 24, 48 and 72 hours was not possible due to coloring by the test substance. Remaining colored test substance was observed until day 8. No edema was reported at all time point. From the 6 days observation time point, no erythema were reported. Erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Foi. Cosm. Tox. 13, 355, 1975). The test item was found to cause no irritation when applied to intact rabbit skin.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was found to be not irritating to skin.

Executive summary:

In a non-GLP study according to a method comparable to OECD guideline 404, the test substance was applied as moistened powder (50% in water) for 20 hours to the rabbit skin on the back. Remaining colored test substance was observed at both observation time points (24 hours and 8 days). No edema was reported at the 24 hours observation time point. At this time point, scoring for erythema was not possible (due to skin coloring). At the 8 days observation time point, no edema and erythema were reported. The test substance was considered to be not irritating.