Registration Dossier

Administrative data

Description of key information

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
Study period:
From 29 JAN 1985 to 05 FEB 1985.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Weight at study initiation: 3.0-3.2 kg
- Housing: individually
- Diet: Altromin 2123 husbandry diet - rabbit (Altromin, Lage/Lippe), ad libitum
- Water: deionised, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
other: polyethylene glycol 400
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 500 mg pasted with 0.65 ml polyethylene glycol 400 (Ch-B 2322, Riedel-de Haen)
Duration of treatment / exposure:
4 h
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm² cellulose patch of a surgical plaster (Baiersdorf)
- Type of wrap if used: semiocclusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm water
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD TG 404
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks:
7 days after exposure.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible
Remarks:
7 days after exposure.
Irritant / corrosive response data:
No edema was observed during the study. 30-60 min and 24 h after exposure 2/3 animals showed erythema score 1, 48 h and 72 h after exposure erythema scores 1 and 2 were observed in these two animals. Animal #2 didn't show any skin response. Seven days after exposure no effects were noted.
Interpretation of results:
GHS criteria not met
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test item is not irritating to skin under these test conditions. The test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

The test item was subject to an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404. Slight erythema were observed in two of three animals, which were fully reversible within seven days. No edema were observed at any time points. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.

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:
From 29 JAN 1985 to 05 FEB 1985.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Guideline study (OECD TG 405).
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Weight at study initiation: 2.9-3.7 kg
- Housing: individually
- Diet: Altromin 2123 husbandry diet - rabbit (Altromin, Lage/Lippe), ad libitum
- Water: deionised, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Vehicle:
other: polyethylene glycol 400
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg pasted with 0.13 ml polyethylene glycol 400 (Ch-B 2322, Riedel-de Haen)
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with ca. 37 °C warm physiol. saline
- Time after start of exposure: 24 h

SCORING SYSTEM: according to OECD TG 405

TOOL USED TO ASSESS SCORE: fluorescein, UV-light
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible
Remarks:
48 h after application.
Irritation parameter:
iris score
Basis:
animal: #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible
Remarks:
7 days after appl.
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible
Remarks:
7 days after appl.
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible
Remarks:
7 days after appl.
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible
Remarks:
7 days after appl.
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks:
48 h after appl.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks:
7 days after appl.
Irritant / corrosive response data:
One hour after application every animal showed chemosis score 2, conjunctival redness score 2 and iris score 1, animal #1 showed cornea score 1. No other corneal effects were observed during the study. 24 h after application animal #1 showed iris score 1. Iridial redness was observed in 3/3 animals one hour after application and in animal #1 24 h after application. No other iridial effects were observed. Conjunctival redness persisted in 3/3 animals with score 1 72 h after application and chemosis of score 1 was observed in 2/3 animals 72 h after application. 7 days after application no effects were observed.
Other effects:
Colourless discharge was observed one hour (3/3 animals), 24 h (3/3 animals), 48 h (2/3 animals) and 72 h (2/3 animals) after application.
Interpretation of results:
GHS criteria not met
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test item is not irritating to eyes under these test conditions. The test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

The test item was subject to an Acute Eye Irritation/Corrosion Test in the rabbit according to OECD TG 405. Corneal opacity was observed only in 1/3 animals one hour after application, fully reversible within 24 hours. Iridial effects were noted in 3/3 animals up to 24 hours after application. Conjunctival redness and Chemosis were observed in 3/3 animals up to 72 hours after application, fully reversible by seven days. As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is not irritating to eyes and has not to be classified for eye irritation.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

Reliable studies (reliability 1 or 2) on skin irritation are available for the Diarylide Yellow Pigments Pigment Yellow 12 and its structural analogues, Pigment Yellow 13, Pigment Yellow 14, Pigment Yellow 17, Pigment Yellow 55, Pigment Yellow 83, Pigment Yellow 126, Pigment Yellow 127, Pigment Yellow 174 and Pigment Yellow 176. The Diarylide Yellow Pigments caused no skin effects (mean erythema or edema score = 0) or only slight transient effects (mean scores </= 2, i.e. well below the critical values for classification), which were fully reversible within the observation time, independently whether the exposure duration was 4 or 24 hours. Additional studies which are considered not to be reliable (reliability 3; Pigment Yellow 81 and Pigment Yellow 55) also reported that the tested substances did not cause skin irritation under the test conditions. In summary, it is concluded that Diarylide Yellow Pigments of this category are not irritating to skin and have not to be classified as skin irritants.

Eye irritation

Reliable studies (reliability 1 or 2) on eye irritation are available for the Diarylide Yellow Pigments Pigment Yellow 12 and its strucutral analogues, Pigment Yellow 13, Pigment Yellow 14, Pigment Yellow 17, Pigment Yellow 55, Pigment Yellow 83, Pigment Yellow 126, Pigment Yellow 127, Pigment Yellow 170, Pigment Yellow 174 and Pigment Yellow 176.

Diarylilde Yellow Pigments showed no effects or only some slight effects in the eyes. As the observed eye responses were all below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, Diarylide Yellow Pigments are considered not to be irritating to eyes and therefore have not to be classified for eye irritation.

Respiratory tract irritation

In three acute inhalation toxicity studies performed with the structural analogues, Pigment Yellow 13 and Pigment Yellow 17 and in two subacute inhalation studies performed with Pigment Yellow 13 no indications for respiratory tract irritation were obtained at gross pathology. No further studies with inhalation exposure are available for Diarylide Yellow Pigments. Based on these data it is concluded that Diarylide Yellow Pigments are not irritating to the respiratory tract and have not to be classified as respiratory tract irritants.

Refer also to Read across justification document, IUCLID Chapter 13.

Justification for classification or non-classification

Studies investigating skin or eye irritation did not reveal any or – if at all – only minimal evidence of irritant potential of Diarylide Yellow Pigments, which were fully reversible. Therefore, Diarylide Yellow

Pigments 12 ohas not to be classified as skin, eye or respiratory tract irritants according to Regulation (EC) No 1272/2008 and Council Directive 67/548/EEC.