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Description of key information

Disperse Yellow 042 is considered to be not irritating to the skin and eyes.

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 6 July, 1993 to 13 July, 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Guidelines followed
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
Lot/batch No.of test material: Terasil gelb GWL roh feucht (FAT 36014/F)
- Expiration date of the lot/batch: April 01, 1998

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature in the dark

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test substance was ground to a powder using a mortar and pestle.The powdery test substance was applied with the aid of a patch. The patch was moistened with distilled water, immediately before application, to ensure close contact of the test substance to the animal's skin.
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands.
- Age at study initiation: Approx 12 weeks
- Weight at study initiation: 2374-2688 g
- Housing: Individually in labelled cages with perforated floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
- Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands) approximately 100 g/d.
- Water: Tap-water diluted with decalcified water, ad libitum
- Acclimation period: At least 5 d after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 55 %
- Air changes: Air-conditioned with 15 air changes/h
- Photoperiod: 12 h artificial fluorescent light/12 h dark

IN-LIFE DATES: From July 6, 1993 to July 13, 1993
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated flank of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 500 mg
Duration of treatment / exposure:
4 h
Observation period:
7 d
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: Approx 10x15 cm²
- Type of wrap if used: The test substance was applied using a moistened Scotchpak-non-woven patch mounted on Micropore tape. The dressing was wrapped around the abdomen and secured with an elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Removed at the end of the exposure period using a tissue moistened with tap-water and subsequently a dry tissue.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
Following exposure a yellow staining of the treated skin-area was noted after removal of the test substance minutes/hours/days after application.
75 minutes, 24 hours, 48 hours, 72 hours, 7 days

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema 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
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Very slight erythema was observed in all three animals. The erythema had resolved within 72 h in one animal and within 7 days in other animals. Oedema was not observed in any of the animals during the observation period. Yellow staining of the treated skin by the test substance was observed in the three animals during the study. The body weights and variability in body weight gain of the animals were considered to be normal. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Other effects:
Except for yellow staining of the treated skin in all three animals, there were no signs of corrosion, body weight variability, toxicity or mortality in any animal during the observation period.
Interpretation of results:
GHS criteria not met
Conclusions:
FAT 36014/F is not irritating to the skin.
Executive summary:

A study was conducted to evaluate the skin irritation potential of the test substance (of 90.7 % purity) in New Zealand White rabbits according to OECD Guideline 404 and EU Method B.4 in compliance with GLP. 500 mg of test substance was applied to a shaved skin area of 10 cm x 15 cm on one flank of each animal under a moistened 2 cm x 3 cm patch. The patch was held in contact with the skin for 4 h. Animals were scored for irritation reactions after 75 minutes, 24, 48 and 72 h, and then 7 d. Animals were monitored daily for viability, mortality and clinical signs. Body weights were recorded pre-test and at study termination. Very slight erythema was observed in all three animals. The erythema had resolved within 72 h in one animal and within 7 days in other animals. Oedema was not observed in any of the animals during the observation period. Yellow staining of the treated skin by the test substance was observed in the three animals during the study. This staining was found to have been reversed by 72 hours in two animals, however it was still present in one animal by the end of observation period of 7 days. The body weights and variability in body weight gain of the animals were considered to be normal. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. Based on the above findings, the scores obtained does not meet the classification criteria as set by the Regulation (EC) No. 1272/2008. Hence, the test substance was considered to be not irritating to the skin.

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 12 July, 1993 to 19 July, 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(February, 1987)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
(December, 1992)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Identified as: FAT 36'014/F
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands.
- Age at study initiation: Approximately 12 weeks
- Weight at study initiation: 2233-2539 g
- Housing: Individually in labelled cages with perforated floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
- Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands) approximately 100 g/d
- Water: Tap-water diluted with decalcified water, ad libitum
- Acclimation period: At least 5 d after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 55 %
- Air changes: Air-conditioned with 15 air changes/h
- Photoperiod: 12 h artificial fluorescent light/12 h dark.

IN-LIFE DATES: From July 12, 1993 to July 19, 1993
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount applied (weight with unit): 87±1 mg/animal
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
Up to 7 d (The eyes of each animal were examined for irritation for approx. 1, 24, 48 and 72 h and 7 d after instillation of the test substance)
Number of animals or in vitro replicates:
3 males
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: Treatment of the eyes with 2 % fluorescein, 24 hours after test substance instillation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
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
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Other effects:
There were no signs of periocular tissue staining, body weight variability, toxicity or mortality in any animal during the observation period.
Interpretation of results:
GHS criteria not met
Conclusions:
FAT 36014/F is not irritating to the eye.
Executive summary:

A study was conducted to assess the eye irritancy potential of the FAT 36014/F (of purity 90.7 %) in New Zealand White rabbits according to OECD Guideline 405 and EU Method B.5 in compliance with GLP. A single ocular dose of 87±1 mg of test substance was applied into the lower eye lid of one eye of each animal. The eyelids were then gently held together for one second before releasing. The untreated eye served as control. Without washing, eyes were scored for irritation reactions at 1, 24, 48, and 72 h and 7 d post-instillation. Slight conjunctival irritation was observed, which resolved within 7 d of instillation. Ocular corrosion was not observed in any of the rabbits. Also, no signs of systemic intoxication were seen. Hence, it can be concluded that the test substance is not to be classified as 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:

The skin irritation potential of Disperse Yellow 042 was evaluated in a number of studies conducted over the years. The findings of these studies indicate it to be not irritating to the skin. The skin irritation potential of FAT 36014/F (purity: 90.7 %) was evaluated using New Zealand White rabbits according to OECD Guideline 404 and EU Method B.4 in compliance with GLP. Very slight erythema was observed in all three animals. The erythema had resolved within 72 h in one animal and within 7 days in other animals. Oedema was not observed in any of the animals during the observation period. Yellow staining of the treated skin by the test substance was observed in the three animals during the study. This staining was found to have been reversed by 72h in two animals, however, it was still present in one animal by the end of observation period of 7 days. Based on the above findings, the scores obtained does not meet the classification criteria as set by the Regulation (EC) No. 1272/2008. Hence, the test substance was considered to be not irritating to the skin.

The skin irritation potential of FAT 36014/D (purity: 57.4 %) was evaluated in a study conducted according to OECD Guideline 404. Only one animal (1/3) had very slight erythema and very slight edema at 24h, which was reversed by 48h. the remaining two exposed animals had no irritation reactions. Hence, under the conditions of the present experiment, FAT 36014/D was found to be not irritating to the skin.

The skin irritation potential of FAT 36014/C (purity: 40.8 %) to rabbit skin was evaluated in a study conducted using the patch test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). No erythema or edema was seen with any of the exposed animals. Hence, the primary skin irritation index in this experiment was established to be 0. Based on the above finding, the test material is concluded to have caused no skin irritation to rabbits.

The skin irritation potential of FAT 36014/B (purity: approx. 20 %) was assessed in rabbits in a study conducted according to the patch test technique as described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). No skin reactions were seen at any of the observations. Hence, it was concluded that FAT 36014/B was found to be not irritating when applied to intact or abraded rabbit skin.

The skin irritation potential of FAT 36014/A (purity: approx. 40 %) was assessed using the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). A mild skin reaction present at 24 hours had resolved by 72 hours. The primary irritation score was 1.3. The scores obtained (erythema for intact skin 1.33 at 24h and 0 for 72h, edema was 0 at 24/72h) does not meet the classification criteria as set by the Regulation (EC) No. 1272/2008. Hence, the test substance was considered to be not irritating to the skin.

Eye irritation:

The eye irritation potential of Disperse Yellow 042 was evaluated in a number of studies conducted over the years. The findings of these studies are discussed below.

The eye irritancy potential of the FAT 36014/F (of purity 90.7%) was assessed using New Zealand White rabbits according to OECD Guideline 405 and EU Method B.5 in compliance with GLP. Slight conjunctival irritation was observed, which resolved within 7 d of instillation. Ocular corrosion was not observed in any of the rabbits. Also, no signs of systemic intoxication were seen. Hence, it can be concluded that the test substance is not to be classified as irritating to the skin.

The eye irritation potential of FAT 36014/D (purity: 57.4 %) was assessed in a study conducted according to OECD guidelines 405. There were no irritation reactions seen with cornea and iris of the exposed animals. Mild reactions were seen with conjunctival redness and chemosis after 1 hour of instillation, which was found to have been reversed by 24 h. Based on these findings, FAT 36014/D is not to be classified as irritating to the eyes.

The eye irritation potential of FAT 36014/C (purity: 40.8 %) was assessed in a study conducted according to the method described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). There was no reaction seen with cornea, iris or conjunctiva. Hence, under the conditions of this experiment, the test material was found to cause no irritation when applied to the rabbit eye mucosa.

A study was conducted to assess the eye irritancy potential of FAT 36014/B (purity: approx. 20 %) in Russian breed rabbits with the procedure described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). FAT 36014/B was found to cause moderate irritation when applied the rabbit eye mucosa. The irritation consisted of corneal opacity, of reflex hyperemia of the iris and of conjunctival reaction. Complete recovery was found in all animals after 8 days. Rinsing the eyes 1 minute following instillation did not change the results. The mean scores obtained for corneal opacity, iris, conjunctival redness and chemosis were 0.83, 0.56, 1.94 and 0.72, respectively. Hence, it was concluded that FAT 36014/B caused slight irritation to the skin.

A study was conducted to assess the eye irritancy potential of FAT 36014/A (purity: approx. 40 %) in New Zealand White rabbits with the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1955), with slight modification. Apart from a slight injection of the conjunctive in three animals all eyes were normal by day six. The mean scores obtained for corneal opacity, iris, conjunctival redness and chemosis were 0.67, 0.11, 1.72 and 1.06, respectively, does not meet the classification criteria as set by the Regulation (EC) No. 1272/2008. Hence, FAT 36014/A is not considered to be irritating to the eyes.

The available studies indicate that Disperse Yellow 042 with increasing purity does not cause irritation to eye. The only exception being FAT 36014/B (purity: approx. 20 %) was found to have some irritation when instilled into the eyes. However, the other batches namely FAT 36014/F (purity: 90.7 %), FAT 36014/D (purity: 57.4 %) and FAT 36014/C (purity: 40.8 %) did not lead to any irritation when introduced in the eyes. FAT 36014/A (purity: approx. 40 %) did cause some irritation, however the threshold scores were not achieved, hence no classification is required. Hence, it can be said that only FAT 36014/B with lowest purity content had some reactions when instilled in the eyes. Taking into consideration the findings of the available studies, the irritation reactions observed with FAT 36014/B can be assumed to have been resulted from the ingredients other than Disperse Yellow 042 and are regarded as not significant. Further, studies with Disperse Yellow 042 with much higher purity content and conducted in compliance with GLP, indicate that the substance is not irritating to the eyes. Based on the above arguments, Disperse Yellow 042 was regarded as not irritating to the eyes.

Justification for classification or non-classification

Disperse Yellow 042 is considered to be not irritating to the skin and eyes, hence it does not warrant classification according to the criteria of Regulation (EC) No. 1272/2008.