Registration Dossier

Administrative data

Description of key information

The in vivo skin irritation study with the rabbit revealed no to moderate formation of erythema and no to very slight edema formation, with all effects being fully reversible. In the two in vivo eye irritation studies with the rabbit very slight conjunctivae redness was observed, the effect was fully reversible. BMDBM therefore is not to be considered as skin irritant or eye irritant.

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:
20/07/1982-23/07/1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Comparable to guideline studies with acceptable restrictions.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive instead of semi-occlusive dressing, scoring after 4 instead of 1h after application.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Animal Farm of Hoffmann-La Roche at Füllinsdorf, Basel-Land, Switzerland
- Weight at study initiation: greater than 2 kg
- Housing: singly in restrainers during first 6 hours of the test, thereafter in stainless cages
- Diet: ad libitum (except on the day of administration)
- Water: tap water ad libitum (except on the day of administration)
- Acclimation period: Minimum of seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 0.5 °C
- Humidity (%): 65 ± 5 %
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: 10 % in ethanol / 2-phenylethanol (50/50) (CAS 60-12-8)

VEHICLE
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
exposure time: 4 or 24 h
Observation period:
up to 72 h after treatment
Number of animals:
Butyl methoxydibenzoylmethane (BMDBM): 6 animals
Vehicle control: 6 animals
Details on study design:
TEST SITE
- Area of exposure: back of the rabbits; left side: abraded skin, right side: intact skin
- coverage: 2x2 cm gauze patch
- Type of wrap if used: occlusive dressing by plastic foil, held in place by elastic network

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 4 and 24 h

SCORING SYSTEM: see Table 1).
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
24 h
Score:
0.83
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
24 h
Score:
0.17
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
48 h
Score:
0.5
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
48 h
Score:
0.17
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
24 h
Score:
1.33
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
48 h
Score:
1.17
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
48 h
Score:
0.5
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
other: see Table 2
Remarks on result:
other: abraded skin
Irritant / corrosive response data:
After 4 h application of BMDBM (as 10 % solution in ethanol / 2-phenylethanole 50/50) to intact or abraded rabbit skin, no to well-defined erythema were observed, resulting in a mean score of 0.67 and 1.17 for intact and abraded skin, respectively. Edemas were less pronounced, showing no to very slight response with mean values of 0.11 and 0.83 for intact and abraded skin, respectively.
When testing the solvent solely, the mean irritation scores for erythema formation were 0.56 and 1.00 for intact and abraded skin, respectively. The edema scores were 0.00 and 0.78 for intact and abraded skin, respectively.
These results indicate that the substance tested possesses a slight irritating potential which is mainly caused by the solvent used.

 Table 2: Primary irritation index after 4 h exposure of 10 % BMDBM in ethanol / 2-phenylethanol (50/50) to intact and abraded skin:

Rabbit No.

Erythema score

Edema score

4 h

24 h

48 h

4 h

24 h

48 h

Intact skin

1

0

0

0

0

0

0

2

1

0

0

0

0

0

3

1

2

1

0

0

0

4

0

2

2

0

1

1

5

1

1

0

0

0

0

6

1

0

0

0

0

0

Mean:

0.67

0.83

0.5

0

0.17

0.17

Abraded skin

1

1

1

1

1

1

1

2

1

1

1

1

1

0

3

1

2

1

1

1

1

4

1

2

2

1

1

1

5

1

1

1

1

1

0

6

1

1

1

1

1

0

Mean:

1

1.33

1.17

1

1

0.5

 

Table 3: Primary irritation index after 4 h exposure of the vehicle (ethanol / 2-phenylethanol (50/50)) to intact and abraded skin:

Rabbit No.

Erythema score

Edema score

4 h

24 h

48 h

4 h

24 h

48 h

Intact skin

1

1

1

1

0

0

0

2

1

0

0

0

0

0

3

1

0

0

0

0

0

4

1

1

0

0

0

0

5

1

1

0

0

0

0

6

1

0

0

0

0

0

Mean:

1

0.5

0.17

0

0

0

Abraded skin

1

1

1

1

1

1

1

2

1

1

1

1

1

0

3

1

1

0

1

1

0

4

1

2

1

1

1

1

5

1

1

1

1

1

0

6

1

1

1

1

1

0

Mean:

1

1.17

0.83

1

1

0.33

 

Interpretation of results:
GHS criteria not met
Conclusions:
Occlusive application of 10 % butyl methoxydibenzoylmethane (BMDBM) in ethanol / 2-phenylethanol for 4 h to intact or abraded rabbit skin caused no to slight erythema and edema. Also the vehicle ethanol / 2-phenylethanol (50/50) causes these effects but in a somewhat lower potency.
Executive summary:

After occlusive application of 0.5 mL of the test item (10 % BMDBM solved in ethanol / 2-phenylethanol (50/50)) for 4 hours to intact or abraded rabbit skin, no to moderate formation of erythema and no to very slight edema formation was noted. The mean scores (erythema/edema) were 0.83/0.17 on intact skin and 1.33/1.00 on abraded skin 24 h after application. Testing the solvent caused no to very slight erythema and edema resulting in scores (erythema/edema) of 0.50/0.00 on intact skin and 1.17/1.00 on abraded skin 24 h after application. It can therefore be concluded that the skin irritations are mainly due to the vehicle used and that BMDBM bears very slight irritating potential. As the erythema/edema score is <2.3 in all animals no classification as skin irritant according to GHS and CLP is needed.

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

Eye irritation

Link to relevant study records

Referenceopen allclose all

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:
comparable to guideline study with acceptable restrictions
Remarks:
Comparable to guideline study under GLP with acceptable restrictions in documentation
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
The test item was dissolved in diethylphtalate, concentration: 5 - 20 %.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
other: diethylphtalate
Controls:
not required
Amount / concentration applied:
0.1 mL of a solution containing 5 %, 10 % and 20 % BMDBM.
Duration of treatment / exposure:
Single application of a 5 %, 10 % and 20 % solution each
Observation period (in vivo):
After 1, 24, 48, and 72 h. Post-observation after 7 and 14 days.
Number of animals or in vitro replicates:
Three animals per dose group.
Details on study design:
SCORING SYSTEM: Draize system
Corneal opacity: 0 - 4
Iris: 0 - 2
Conjunctival redness: 0 - 3
Conjunctival swelling (chemosis): 0 - 4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 5 % solution
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: 5 % solution
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: 5 % solution
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 5 % solution
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 10 % solution
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: 10 % solution
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0.44
Max. score:
3
Reversibility:
fully reversible within: 2 - 3 d
Remarks on result:
other: 10 % solution
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 10 % solution
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 20 % solution
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: 20 % solution
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 3 d
Remarks on result:
other: 20 % solution
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 20 % solution
Irritant / corrosive response data:
As given above, single application of a 5 - 20 % solution of BMDBM in diethylphtalate caused weak shortlasting conjuncticval irritation of the rabbit eye. No alteration of the cornea was observed macroscopically.
Other effects:
No further effects were reported.
Interpretation of results:
GHS criteria not met
Conclusions:
The 20 % solution of butyl methoxydibenzoylmethane (BMDBM) dissolved in diethylphtalate caused weak shortlasting conjunctival irritation of the rabbit eye. No alterations of the cornea was observed macroscopically. Therefore, BMDBM can be considered as non-irritant to the eye and no classification according to EU CLP is needed.
Executive summary:

The determination of eye irritating effects of butyl methoxydibenzoylmethane (BMDBM) was performed in a study similar to OECD Guideline 405 on three rabbits: BMDBM as 5 %, 10 %, and 20 % solution in diethylphtalate was placed in the conjunctival sac of one rabbit eye and the effects are recorded after 1 h, 24 h, 48 h, 72 h, 7 days and 14 days. Observations comprised opacity of the cornea, iris reaction, conjunctival redness and swelling (chemosis).

The instillation of a solution of BMDBM caused concentration-dependent weak conjunctival irritation of the rabbit eye which was fully reversible within up to 3 days. The mean irritation scores for the 20 % solution (3 animals, 24 - 72 h after administration) were 0 (Cornea opacity), 0 (Iris), 0.67 (Conjunctivae redness), 0 (Chemosis). Therefore, BMDBM can be considered as non-irritant to the eye and no classification according to EU CLP is needed.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1987-12-01 - 1988-02-03
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Guideline study under GLP with slight methodological deficiency (use of 3 % test item-containing sunscreen).
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
A 3 % solution of BMDBM in sunscreen was used as test item and not BMDBM as such.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Mandoerin AG, CH-4414 Füllinsdorf/Switzerland
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: 1.9 - 2.5 kg
- Housing:individually in stainless steel cages with automatic cleaning and drinking system
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4 days under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 40 - 70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1987-12-01 To: 1987-12-04
Vehicle:
other: Sunscreen cream Ref. 260587/E
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg of sunscreen containing 3 % BMDBM (equivalent to an amount of 3 mg BMDBM)
Duration of treatment / exposure:
The test article was placed in the conjunctival sac of the left eye of each animal. No rinsing of the eye to remove the test item was described.
Observation period (in vivo):
The eyes of each animal were examined 1, 24, 48, and 72 hours after administration.
Number of animals or in vitro replicates:
3 animals (2 males and 1 female)
Details on study design:
SCORING SYSTEM: according to OECD 405

TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0.4
Max. score:
13
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.2
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
IRRITATION
Sunscreen cream 260587/E, containing 3 % BMDBM, showed a primary irritation score of 0.4, when applied to the rabbit eye mucosa.

COLORATION
In the area of application no staining of the cornea and conjunctivae by pigment or coloring of the test article was observed.
Other effects:
TOXIC SYMPTOMS
No acute toxic symptoms were observed in the animals during the test period, and no mortality occured.

BODY WEIGHTS
The body weight gain of all rabbits were similar.

NECROPSY
Due to the result obtained, no macroscopic organ examination was indicated.

Table 1: Eye irritation scores of rabbits treated with 100 mg sunscreen cream 260587/E, containing 3 % BMDBM

Animal & Sex

Cornea opacity

Iris

Conjunctivae redness

Chemosis

Cumulative score

1 h

1

2

3

M

M

F

0

0

0

0

0

0

1

1

1

0

0

0

1

1

1

24 h

 

 

 

 

 

 

1

2

3

M

M

F

0

0

0

0

0

0

0

1

1

0

0

0

0

1

1

48 h

 

 

 

 

 

 

1

2

3

M

M

F

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

72 h

 

 

 

 

 

 

1

2

3

M

M

F

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Interpretation of results:
GHS criteria not met
Conclusions:
Application of 100 mg sunscreen cream 260587/E, containing 3 % BMDBM, into the rabbit eye caused an overall irritation score of 0.4 (1 - 72 h). The mean scores 24 - 72 h after administration were 0 (Cornea opacity), 0 (Iris), 0.2 (Conjunctivae redness), 0 (Chemosis). The effects were fully reversible within 48 h.
Therefore, the test item sunscreen cream 260587/E, containing 3 % BMDBM can be considered as non-irritant to the eye and no classification according to GHS and CLP is needed.
Executive summary:

Under the conditions of this experiment, sunscreen cream 260587/E, containing 3 % BMDBM, was found to cause a primary irritation score of 0.4 (1 - 72 h), when applied to the rabbit eye mucosa.

The individual mean scores 24 - 72 h after administration were 0 (Cornea opacity), 0 (Iris), 0.2 (Conjunctivae redness), 0 (Chemosis). The effects were fully reversible within 48 h. No staining of the cornea and conjunctivae of the treated eyes by pigment or colouring of the test article was observed. No corrosion was observed at any of the measuring Intervals.

Therefore, the test item sunscreen cream 260587/E, containing 3 % BMDBM can be considered as non-irritant to the eye and no classification according to GHS and CLP is needed.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

In the study by Kleczak (1982), skin irritation was tested by occlusive application of a 10 % BMDBM solution for 4 h on intact or abraded rabbit skin. The results revealed no to moderate formation of erythema and no to very slight formation of edema. Testing the solvent caused no to very slight erythema and edema formation.

Therefore, the authors concluded that the irritating potential can mainly be attributed to the solvent used and that BMDBM is at best slightly irritating to skin.

 

Eye irritation:

In two studies by Kleczak (1988 and 1978), eye irritation was tested in the rabbit eye. Both test items, which were a sunscreen cream containing 3 % BMDBM and different BMDBM solutions (5 - 20 % BMDBM), caused only very slight conjunctival redness (grade 1 of 4) which was fully reversible within 2 - 3 days. Therefore, BMDBM can be considered as not irritating to the 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. As a result the substance is not considered to be classified for skin corrosion/irritation and eye damage/irritation under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.