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Description of key information

Not irritating on rabbit skin (OECD 404)

Not irritating in rabbit eyes (OECD 405)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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:
comparable to guideline study with acceptable restrictions
Remarks:
Observation period only 72 hours. Erythema not scorable for most animals at 24h reading.
Qualifier:
according to guideline
Guideline:
other: US Code of Federal Regulations, Title 16, Section 1500.41
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24h exposure, scoring only at 24h and 72h
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
24h
Observation period:
72h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: no data, just reference to guideline given
- % coverage: no data, just reference to guideline given
- Type of wrap if used: no data, just reference to guideline given

REMOVAL OF TEST SUBSTANCE
- Washing: not specified
- Time after start of exposure: 24h

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
other: partly reversible within 72h (score: 1). No scoring done for later time points.
Remarks on result:
other: Value for animals with intact skin.
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
24 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: Values for animals with intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
5 of 6 animals
Time point:
72 h
Score:
0.2
Max. score:
4
Remarks on result:
other: One animal could not be scored due to yellow staining. Values for animals with intact skin.

Only values from animals with intact skin were used for assessment.

Table 1: Individual skin irritation scores

Rabbit No.

Reaction

24 hours

72 hours

1

Erythema

?

0

 

Edema

0

0

2

Erythema

?

0

 

Edema

0

0

3

Erythema

?

0

 

Edema

0

0

4

Erythema

2

1

 

Edema

0

0

5

Erythema

?

0

 

Edema

0

0

6

Erythema

?

?

 

Edema

1

0

?: no scoring possible due to yellow staining of the skin

Interpretation of results:
GHS criteria not met
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
Study period:
2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
- Expiration Date: May 18, 2021
- Lot # : 2757
- Stability under test conditions: stable for the duration of testing
- Storage condition of test material: room temperature
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Robinson Services, Inc. (USA)
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 - 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 63-83
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: June 6-16, 2011
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mL (0.03 mg)
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein

Prior to instillation, 2-3 drops of ocular anesthetic (Tetracaine Hydrochloride Ophthalmie Solution, 0.5%) were placed into both the treated and control eye of each animal. One-tenth of a milliliter (0.03 g) of the test substance was then instilled into the conjunctival sac of the right eye of each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance. The other eye of each rabbit remained untreated with the test substance and served as a control.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
There was no corneal opacity or iritis observed in any treated eye during the study. Within one hour after test substance instillation, all three treated eyes exhibited minimal conjunctivitis. All animals were free of ocular irritation by 24 hours.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin:
Reliable data from several studies on skin irritation are available for four members of the 'yellow disazo condensation pigments' (CAS 5580-57-4, 5280-80-8, 68516-73-4, 79953-85-8). These data reveal a very low skin irritation potential for the 'yellow disazo condensation pigments'. In a primary dermal OECD guideline irritation study (OECD 404, Ciba-Geigy Ltd., 1983), 3 female New Zealand White rabbits were dermally exposed to 0.5 g of the test substance (CAS 5280-80-8) for 4 hours under semiocclusive conditions. Animals then were observed for 7 days. Irritation was scored by the method of Draize as described in the OECD guideline 404. The mean score for the 24, 48 and 72 h reading for erythema was 0.44 and for edema was 0. The skin reactions observed were fully reversible within 48 hours. Under the conditions of the present experiment the test substance (CAS 5280-80-8) was found to be non-irritant and not corrosive when applied to the rabbit skin. For three further test substances of the 'yellow dazo condensation pigments' (CAS 5580-57-4, 68516-73-4, 79953-85-8) similar results were found although the treatment was under more severe conditions: On the intact skin (flanks) of three rabbits 0.5 g of the substance, moistened with tap water or polyethylene glycol, was applied onto skin for 24h under occlusive conditions. Observations 24h, 48h, 72h, after treatment did not reveal formation of erythema or edema or only light erythema.
No reliable study on skin irritation of one 'yellow diazo condensation pigment' (CAS 5580-58-5) is available. But due to the consistent observation that the other 'yellow disazo condensation pigments' do not induce skin irritation it is concluded that this member is also not irritating to skin. In summary, it is concluded that 'yellow disazo condensation pigments' are not irritating to skin and have not to be classified as skin irritants.
 
Eye:
Reliable data from two studies on eye irritation are available for the test substance.

An eye irritation test according to OECD guideline 405 with three New Zealand White rabbits is available for the test substance (Dominion, 2011). Eyes were left unwashed after application of one-tenth of a milliliter (0.03 g) of test substance and the animals were observed for 72 hours. The scores for the test substance were all 0 for conjunctivae redness, corneal opacity, iris, and conjunctivae chemosis.

In a supporting study similar to OECD guideline 405, the eyes of 6 rabbits were treated with 30 mg of the test substance and were observed for 7 days (Clariant, 1980). The mean scores for all animals were all 0 for cornea, iris, conjunctivae redness and conjunctivae chemosis.

Thus, the test substance is not considered to be irritating to the rabbit eyes.

 


Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin irritation/corrosion and eye irritation, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP.