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Administrative data

Description of key information

FAT 20290/A is found to be a non-irritant to 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:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: United States Environmental Protection Agency (EPA), Paragraph 163.81-5 "Primary dermal irritaion study", Federal Register, Vol 43 No. 163, August 22, 1978.
Deviations:
not specified
Principles of method if other than guideline:
None
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414, Fuellinsdorf
- Weight at study initiation: 2-3 kgs
- Housing: Caged individually
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland); ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C
- Humidity: 55±15 %
- Photoperiod: Animals were exposed to artificial light for 12 hours light/day
- Air changes: 15 air changes/h
Type of coverage:
occlusive
Preparation of test site:
other: shaved as well as abraded
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
7 d
Number of animals:
six (three males and three females)
Details on study design:
TEST SITE
- Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin
on one side was slightly scarified with the help of a "Schroepfschnaepper", Aesculap, Switzerland. Gauze patches of 2.5 x 2.5 cm soaked with 0.5 ml of
the test material were applied to the prepared abraded and intact skin.

- The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after 24 hours. The skin reaction was assessed upon removal and during a subsequent observation period of 7 days.
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7d
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 7d
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7d
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
animal #4
Remarks:
mean
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
(abraded skin)
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 7d
Irritation parameter:
erythema score
Remarks:
(abraded skin)
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 7d
Irritation parameter:
erythema score
Remarks:
(abraded skin)
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7d
Irritation parameter:
erythema score
Remarks:
(abraded skin)
Basis:
animal #4
Remarks:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Remarks:
(abraded skin)
Basis:
animal #5
Remarks:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Remarks:
(abraded skin)
Basis:
animal #6
Remarks:
mean
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
(intact skin)
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7d
Irritation parameter:
edema score
Remarks:
(intact skin)
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 7d
Irritation parameter:
edema score
Remarks:
(intact skin)
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7d
Irritation parameter:
edema score
Remarks:
(intact skin)
Basis:
animal #4
Remarks:
mean
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
(intact skin)
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
(intact skin)
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
(abraded skin)
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 7d
Irritation parameter:
edema score
Remarks:
(abraded skin)
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 7d
Irritation parameter:
edema score
Remarks:
(abraded skin)
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7d
Irritation parameter:
edema score
Remarks:
(abraded skin)
Basis:
animal #4
Remarks:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
(abraded skin)
Basis:
animal #5
Remarks:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
(abraded skin)
Basis:
animal #6
Remarks:
mean
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritant / corrosive response data:
FAT 20290/A was found to cause slight irritation when applied to intact and abraded rabbit skin.
Other effects:
None

FAT 20290/A was found to cause slight irritation when applied to intact and abraded rabbit skin. The scores read after 24 and 72 hours for erythema and edema for the intact as well for the abraded skin was were summed up and divided by 4 (FHSLA paragraph 191.11). Primary irritation index of 1.9 was recorded. But it can be noted that abrasion on skin causes epidermal injury and further expected to cause the skin irritation and adverse effects to epidermis. This reaction could be referred to the damage caused due to abrasion rather than due to the test substance application. In general abrasion is an elevated testing condition and results normally do not have to be taken into account for hazard assessment. Hence, The test substance FAT 20290/A can be regarded as not irritating to rabbit skin.

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20290/A can be regarded as not irritating to rabbit skin.
Executive summary:

An in vivo study was conducted to evaluate the skin irritation potential of the test substance in rabbits according to the Guidelines of the United States Environmental Protection Agency (EPA), Paragraph 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43 No. 163, and August 22, 1978. Gauze patches of 2.5 x 2.5 cm soaked with 0.5 ml of the test material were applied to abraded and intact skin of 6 rabbits. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after 24 hours. The skin reaction was assessed upon removal and during a subsequent observation period of 7 days. FAT 20290/A was found to cause slight irritation when applied to intact and abraded rabbit skin. However, the scores recorded were below the threshold scores required for classification as recommended by Regulation (EC) No. 1272/2008. Hence, FAT 20290/A can be regarded as not irritating to rabbit 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:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study" Federal Register, Vol. 43, No. 163, August 22, 1978.
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Remarks:
After checking for normal ophthalmic conditions
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 3 to 4 months
- Weight at study initiation: Males: 2- 3 kgs
- Housing: Caged singly
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAGAG/ Gossau, SG (Switzerland), ad libitum
- Water: ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3 °C
- Humidity: 55±15%
- Photoperiod: Animals were exposed to artificial light for 12 hours light/day
- Air changes: 15 air changes/h
Vehicle:
not specified
Controls:
other: untreated right eye
Amount / concentration applied:
- Amount(s) applied: 0.1 ml
Duration of treatment / exposure:
Unwashed eye: unspecified (not rinsed after single instillation)
Washed eye: 30 sec
Observation period (in vivo):
7d
Number of animals or in vitro replicates:
Six rabbits (three males and three females)
Details on study design:
PROCEDURE:
-The procedure used is based but not in every part identical with the Proposed Guidelines of the United States Environmental Protection Agency (EPA)
Paragraph 163.81-5 "Primary eye irritation study"r Federal Register, Vol. 43 No. 163 August 22, 1978.

- The test material in an amount of 0.1 ml was inserted in the conjunctival sac of the left eye of the rabbits and the lids were gently closed for 15 seconds. The right eye was not treated and served as an untreated control.
- The eye irritation was assessed with a slit-lamp at 24, 48, 72 hours and 4 and 7 days after treatment

REMOVAL OF TEST SUBSTANCE
In 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was flushed with 10 ml of sterile physiological saline.

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM:

Cornea
A. Opacity and degree of density (area most dense taken for reading)
No opacity 0
Scattered or diffuse areas, details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Opalescent areas, no details of iris visible, size of pupil barely discernible 3
Opaque, iris invisible 4

B. Area of cornea involved
One quarter (or less) but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4
A x B x 5 Maximum possible score = 80

Iris
A. Values
Normal 0
Folds above normal, congestion, swelling, circumcornea injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, hemorrhage, gross destruction (any or all of these) 2
A x 5 Maximum possible score = 10

Conjunctivae
A. Redness (refers to palpebral and bulbar conjunctivae, excluding cornea and iris)
Blood vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not easily discernible 2
Diffuse beefy red 3

B. Chemosis
No swelling 0
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids about half closed to completely closed 4

C. Discharge
No discharge 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs, and considerable area around the eye 3
(A + B + C) x 2 Maximum possible score = 20
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of abnormal reaction was seen in any animals after application of the test substance. Hence the primary irritation index was 0.
Other effects:
No abnormalities reported.
Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20290/A was considered to be not an eye irritant.
Executive summary:

A study was conducted to assess the eye irritancy potential of the test substance in rabbits according to United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study Federal Register, Vol. 43 No. 163 August 22, 1978.

The test material in an amount of 0.1 ml was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for 15 seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was flushed with 10 ml of sterile physiological saline. The eye irritation was assessed with a slit-lamp at 24, 48, 72 hours and 4 and 7 days after treatment.

No signs of abnormal reaction were seen in any animals after application of the test substance. Hence the primary irritation index was 0. Hence, based on the findings of the study, FAT 20290/A was not an eye irritant.
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 Acid Blue 314 (FAT 20290/A) was evaluated in a study conducted according to the Guidelines of the United States Environmental Protection Agency (EPA), Paragraph 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43 No. 163, and August 22, 1978. Gauze patches of 2.5 x 2.5 cm soaked with 0.5 ml of the test material were applied to abraded and intact skin of 6 rabbits. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after 24 hours. The skin reaction was assessed upon removal and during a subsequent observation period of 7 days. FAT 20290/A was found to cause slight irritation when applied to intact and abraded rabbit skin. However, the scores recorded were below the threshold scores required for classification as recommended by Regulation (EC) No. 1272/2008. Hence, FAT 20290/A can be regarded as not irritating to rabbit skin.

 

Eye irritation:

The eye irritancy potential of Acid Blue 314 (FAT 20290/A) was evaluated in a study conducted according to United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study Federal Register, Vol. 43 No. 163 August 22, 1978. The test material in an amount of 0.1 ml was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for 15 seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was flushed with 10 ml of sterile physiological saline. The eye irritation was assessed with a slit-lamp at 24, 48, 72 hours and 4 and 7 days after treatment. No signs of abnormal reaction were seen in any animals after application of the test substance. Hence the primary irritation index was 0. Hence, based on the findings of the study, FAT 20290/A was not an eye irritant.

 

Taking into consideration data from both skin and eye irritation/corrosion studies, it can be concluded that the test substance FAT 20290 is non-irritating to skin and eye.

Justification for classification or non-classification

Based on the finding in the skin and eye irritation studies, Acid Blue 314 does not need to be classified according to the criteria of EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.