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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The test was performed following official guideline and meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Appraisal of the safety of Chemicals in Food, Drugs and Cosmetics (1959) of the US association AFDO
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[[2-sulphonato-4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate]
EC Number:
220-027-3
EC Name:
Hexasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[[2-sulphonato-4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate]
Cas Number:
2610-10-8
Molecular formula:
C45H32N10O21S6.6Na
IUPAC Name:
hexasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[[2-sulphonato-4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulpho
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Age at study initiation: adult animals- Weight at study initiation: 1.5 - 2 kg- Housing: single housing in V2A wire cages- Diet: standard rabbit food ad libitum (NAFAG, No. 814, Gossau SG)- Water: ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved intact and scarified skin
Vehicle:
other: polyethylene glycol 100%
Controls:
other: untreated skin of same animal
Amount / concentration applied:
TEST MATERIAL- Amount applied: 0.5 g- Concentration: 50%
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 (3 males + 3 females)
Details on study design:
TEST SITE- Area of exposure: 2.5 cm x 2.5 cm on back and flank- Type of wrap: plastic films of 5 x 5 cm fixed to the body with adhesive tape

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
No irritant response data after a 24-hours occlusive exposure to intact skin. The primary irritaion index is 0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material is not irritating to the rabbit skin.
Executive summary:

The test item was tested for skin irritation and the test results showed a primary irritation index of 0 in all the trated animals.

Direct Red 80 could be considered as a not skin irritant.