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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Non skin irritating 
Non irritating to eye

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
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
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
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: 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.
Qualifier:
according to guideline
Guideline:
other: Appraisal of the safety of chemicals in Foods, Drugs and Cosmetics (1959) of the association (AFDO).
Deviations:
not specified
GLP compliance:
not specified
Species:
rabbit
Strain:
other: Russian Breed
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: Exp. Toxicology, CIBA-Geigy Ltd.- Housing: single housing in V2A wire cages - Diet: standard rabbit food ad libitum (NAFAG, No. 814, Gossau SG)- Water: ad libitum
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of same animal
Amount / concentration applied:
TEST MATERIAL- Amount applied: 0.1 g
Duration of treatment / exposure:
few seconds
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 (3 males + 3 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing: In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.SCORING SYSTEM: according to DraizeTOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: unrinsed and rinsed
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: unrinsed and rinsed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.4
Max. score:
3
Reversibility:
fully reversible within: 96 hours
Remarks on result:
other: unrinsed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.4
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: rinsed
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
The tested substance showed some irritating effect on conjunctivae during the first 24 hours but the irritation signs were fully reversible within 96 hours for the unrinsed eyes. No effects on iris and on cornea.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this experiment the test material was found to cause a minimal irritation during the first 24 hours, the irritation effects were fully reversible within 96 hours for the unrinsed eyes. The test material is considered to be not irritating to the eye.
Executive summary:

Based on the test results, the test material is considered to be not irritating to the eye.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation/corrosion

Three studies on four are according to identify Similar Substance 01 as skin not irritating; Clariant 2002 study has been performed with a concentration of 87.5% and Clariant 2007 with a cocentration of 70%.

The studies on structural analogues Similar Substance 02 and 03 confirm the not irritability for skin .

 

Eye irritation

It was noted that test material produced moderate conjunctival irritation, reported in Clariant 2007 report. It is possible that similar substance 01 could be irritating to eye in some conditions, expecially if in powder form; however the eventually disadvantages can be easy obviated by correctly using of the substance with the necessary preautions.

In any case none of those effects are enough to classify the substance as irritant, according to CLP regulation (EC1272/2008).

 

Respiratory irritation

Tests on this pourpose have not been conducted; nevertheless Direct Red 80 is not expected to be a respitatory irritant.

Justification for classification or non-classification

According to CLP regulation (EC1272/2008) the tested substance is not classified as skin/eye/respiratory irritant.