N-ethylpropylamine

Endpoint summary

Description of key information

- skin: corrosive (in vivo, rabbit (BASF AG 1980) + in vitro EpiDerm (BASF SE 2010) and Corrositex (BASF AG 2009))
- eye: severe eye damage (in vivo, rabbit (BASF AG 1980))

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18. Jul 1979 - 26. Jul 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

BASF-Test:
Two animals were treated for 3 min or 1 h using occlusive conditions. An application site of 2 x 2 cm was covered with the liquid test substance. The animals were observed for 8 days and skin changes were recorded daily.

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3.4 kg (mean)

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Duration of treatment / exposure:

3 min or 1 h

Observation period:

8 days

Number of animals:

2 for each exposure period

Details on study design:

TEST SITE
- Area of exposure: 2 x 2 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): concentrated Lutrol and 50 % Lutrol
- Time after start of exposure: 3 min or 1 h

SCORING SYSTEM:
according to Draize

Irritation parameter:

other: necrosis

Basis:

animal: 1 & 2

Time point:

other: 8 days

Remarks on result:

other: full thickness necrosis after 3 min and 1 h exposure at the end of the observation period of 8 days

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(animal 1 - 2)

Time point:

24/48 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

(within 8 days)

Remarks on result:

other: 3 min and 1 h exposure; 72 h reading is missing.

Irritation parameter:

edema score

Basis:

mean

Remarks:

(animal 1 - 2)

Time point:

24/48 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks:

(within 8 days)

Remarks on result:

other: 3 min and 1 h exposure; 72 h reading is missing

72 h reading is missing

Exposure:	3 min			Comment
Animal	Reading	Erythema	Edema
1	3 min	2	2	brownish
2	3 min	2	2	brownish
1	24 h	4	2	Necrosis
2	24 h	4	2	Necrosis
1	48 h	4	2	Necrosis
2	48 h	4	2	Necrosis
1	5 d	4	2	Necrosis
2	5 d	4	2	Necrosis
1	8 d	4	2	Necrosis; full thickness
2	8 d	4	2	Necrosis; full thickness
mean (animal 1 & 2)	24 - 48 h	4.0	2.0
Exposure:	1 h			Comment
Animal	Reading	Erythema	Edema
1	1 h	4	2	Necrosis
2	1 h	4	2	Necrosis
1	24 h	4	2	Necrosis
2	24 h	4	2	Necrosis
1	48 h	4	2	Necrosis
2	48 h	4	2	Necrosis
1	5 d	4	2	Necrosis
2	5 d	4	2	Necrosis
1	8 d	4	2	Necrosis; full thickness
2	8 d	4	2	Necrosis; full thickness
mean (animal 1 & 2)	24 - 48 h	4.0	2.0

Interpretation of results:

Category 1A (corrosive) based on GHS criteria

Reference 2

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: OECD 431 (In vitro Skin Corrosion: Human Skin Model Test, 13.04.2004)

Deviations:

no

Principles of method if other than guideline:

The corrosive potential of the test substance was assessed using the EpiDerm Test.

GLP compliance:

yes (incl. QA statement)

Remarks:

(BASF SE, Experimental Toxicology and Ecology)

Test system:

human skin model

Remarks:

Epi-200 tissues (reconstructed three dimensional human epidermis)

Source species:

human

Vehicle:

unchanged (no vehicle)

Details on test system:

Negative control (NC): Highly de-ionized water
Positive control (PC): 8 N potassium hydroxide solution (Sigma-Aldrich, Munich, Germany)
MTT-reduction control (KC): Highly de-ionized water or test substance

Mesh compatibility:
For liquid test substances a nylon mesh can be used as a spreading support. To exclude a reaction of the test substance with the mesh, the compatibility of the test substance with the nylon mesh was checked in a pretest. The test substance and the mesh are brought together on a slide and the reaction was observed after 60 minutes exposure, using a microscope.

Direct MTT reduction:
To assess the ability of the test material to directly reduce MTT a pretest was performed. In case that direct MTT reduction occurred, one freeze-killed control tissue per exposure time was treated with, each, the test article and the negative control, in the same way as described in section “Basic procedure”, additionally.

Basic procedure :
From the day of arrival in the laboratory, the tissues were kept in the refrigerator. At least 1 hour but not more than 1.5 hours before test-substance application, tissues were transferred to 6-well plates with 0.9 mL assay medium and preconditioned in the incubator at 37°C. The preincubation medium was replaced with fresh medium immediately before application.
The tissues were washed with PBS to remove residual test material 3 minutes or 1 hour after start of the application treatment. Rinsed tissues were kept in 24-well plates (holding plates) at room temperature on assay medium until all tissues per application time were dosed and rinsed. The assay medium was then replaced by MTT solution and tissues were incubated for 3 hours.
After incubation, tissues were washed with PBS and the formazan produced by the tissues was extracted with isopropanol over night at room temperature. The optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically. Blank values were established of 6 microtiter wells filled with Isopropanol for each microtiter plate.
The OD570 values determined for the various tissues are measures of their viability. The quotient of the OD570 of tissues treated with the test material and the mean OD570 values of the NC (percent of control) together with the respective exposure time is used for evaluating whether or not a test material is corrosive.
In case of direct reduction of MTT by the test substance, the OD570 values measured in the freeze-killed control tissues (KC) will be used to correct the mean OD570 of the test substance treated tissues (mean OD570 KC corrected).

Aceptance criteria:
In case one of the below given acceptance criteria is not covered, repetition of the test is considered.

Assay acceptance criterion for the negative control (NC):
The absolute OD570 of the negative control tissues in the MTT-test is an indicator of tissue viability obtained in the testing laboratory after the shipping and storing procedure and under specific conditions of the assay. Tissue viability is acceptable if the mean OD570 of the NC is ≥ 1.0. The mean OD570 of the NC should not exceed 2.5.
Assay acceptance criterion for the positive control (PC):
Potassium hydroxide as 8.0 normal ready made solution is used as positive reference. A 3-minute treatment with 8.0 n KOH usually reveals a mean relative tissue viability of ~20%. An assay is acceptable if mean relative tissue viability of the 3 min positive control is ≤ 30%.
Assay acceptance criterion for tissue variability:
For every treatment, except the killed controls, 2 tissues are treated in parallel. The inter-tissue variability is considered to be acceptable if the difference of the OD570 values of the two tissues is ≤ 0.3.
Assay acceptance criterion for killed controls (KC):
The OD570 of the killed control tissues treated as negative control should be ≤ 0.35.

Evaluation of results:
Corrosive potential of the test materials is predicted from the mean relative tissue viabilities obtained after 3 min treatment compared to the negative control tissues concurrently treated with highly de-ionized water. A chemical is considered as "corrosive", if the mean relative tissue viability after 3 min treatment with a test material is decreased below 50%. In addition, those materials with a viability of ≥ 50% after 3 min treatment are considered as "corrosive" if the mean relative tissue viability after 1 hour treatment with a test material is decreased below 15%.

Comparison with historical controls were made.

Control samples:

yes, concurrent no treatment

yes, concurrent positive control

Amount/concentration applied:

50µl

Duration of treatment / exposure:

3 minutes at room temperature or 1 hour in the incubator

Number of replicates:

Two tissues per exposure time and test group (1 killed tissue per exposure time was treated in order to detect direct MTT reduction)

Irritation / corrosion parameter:

% tissue viability

Remarks:

3min

Run / experiment:

mean (exp. 1&2)

Value:

36

Vehicle controls validity:

valid

Positive controls validity:

valid

Irritation / corrosion parameter:

% tissue viability

Remarks:

1h

Run / experiment:

mean (exp. 1&2)

Value:

15

Vehicle controls validity:

valid

Positive controls validity:

valid

Mesh compatibility

No interaction between test substance and the mesh was noticed. Therefore the test substance was applied using a mesh for spreading.

Results:

1st experiment:
		Exposure: 3 min				Exposure: 1 h
Test article		tissue 1	tissue 2	KC	mean	tissue 1	tissue 2	KC	mean
NC	mean OD570	1.6473	1.5628	0.1298	1.6051	1.5057	1.4982	0.1307	1.5019
	viability [% of NC]	102.6	97.4	---	100	100.2	99.8	---	100
Test article	mean OD570	0.6068	1.1108	0.1573	0.8588	0.2622	0.2427	0.1422	0.2524
	viability [% of NC]	37.8	69.2	---	54	17.5	16.2	---	17
PC	mean OD570	0.3728	0.5183	---	0.4456	0.1722	0.1472	---	0.1597
	viability [% of NC]	23.2	32.3	---	28	11.5	9.8	---	11

As the inter-tissue variability of the 3-min exposure time of the test substance is out of the acceptance criterion and because of the borderline results of both exposure periods the test was repeated.

2nd experiment:
		Exposure: 3 min				Exposure: 1 h
Test article		tissue 1	tissue 2	KC	mean	tissue 1	tissue 2	KC	mean
NC	mean OD570	1.2662	1.4622	0.1767	1.3642	1.6587	1.7942	0.0807	1.7264
	viability [% of NC]	92.8	107.2	---	100	96.1	103.9	---	100
Test article	mean OD570	0.2407	0.2197	0.1847	0.2302	0.2212	0.1862	0.1747	0.2037
	viability [% of NC]	17.6	16.1	---	17	12.8	10.8	---	12
PC	mean OD570	0.3322	0.3452	---	0.3387	0.2282	0.1947	---	0.2114
	viability [% of NC]	24.3	25.3	---	25	13.2	11.3	---	12

Due to the ability of the test substance to reduce MTT directly, a KC was introduced in both experiments. However, the results of the KCs did not indicate an increased MTT reduction. Thus the KCs were not used for viability calculation.

Interpretation of results:

study cannot be used for classification

Remarks:

positive indication of corrosion

Reference 3

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

Draize Test (Federal Register 38, No. 187 § 1500.41 (skin), p. 27019, 23.09.1973):
Six rabbits were treated for 24 h using occlusive conditions. An application site of 2.5 x 2.5 cm (intact and scarificed) was covered with the liquid test substance. The animals were observed for 7 days.

GLP compliance:

no

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3 - 4 kg
- Housing: single
- Diet: standard pellet feed for rabbits ad libitum
- Water: ad libitum
- Acclimation period: > 3 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23 °C
- Humidity (%): 50 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Preparation of test site:

other: intact and scarified

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

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 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm (6.25 cm²)
- Type of wrap if used: covered by a gauze patch which was securely taped in place (Gazofix, No. 2938, Beiersdorf); additionally, the trunk was wrapped with a PVC foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol-water-solution
- Time after start of exposure: 24 h

SCORING SYSTEM: according to Draize

Irritation parameter:

other: Necrosis

Basis:

other: in 2 animals

Time point:

other: 7 days

Remarks on result:

other: in 2 animals 7 days after administration (end of the observation period); not known whether full thickness or not

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(animal 1 - 6)

Time point:

other: 24 h - 72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: 48 h reading is missing

Irritation parameter:

edema score

Basis:

mean

Remarks:

(animal 1 - 6)

Time point:

other: 24 h - 72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Remarks on result:

other: 48 h reading is missing

Irritant / corrosive response data:

Skin at application area leathery and dry with a red-brown-blackish colour.
At necropsy: Skin brown-blackish with a dry crust; 5 animals showed reddening of the cutaneous tissue which extended in 3 animals into the muscular system. Two animals showed necrosis (slushy consistence).

Mean erythema score after 24 h and 72 h (48 h time point is missing) (animal 1/2/3/4/5/6; intact skin)

	Animal 1	Animal 2	Animal 3	Animal 4	Animal 5	Animal 6
24 h	4	4	4	4	4	4
72 h	4	4	4	4	4	4

Mean erythema score: 4.0

Irritation Index: 4 (maximum: 8; moderate irritant)

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Reference 4

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

non GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

Deviations:

no

Principles of method if other than guideline:

The corrosive potential of the test substance was assessed using the Corrositex Test.

GLP compliance:

no

Test system:

artificial membrane barrier model

Remarks:

Corrositex Biobarrier Membrane (reconstituted collagen matrix)

Vehicle:

unchanged (no vehicle)

Details on test system:

The assay is based on the time that is required for the test article to break through the Corrositex® Biobarrier Membrane (reconstituted collagen matrix) and produce a change in the Chemical Detection System.

In addition to the test substance, the following three reference substances were selected from the list given in OECD Guideline 435 and were tested in parallel to the test substance:

Sulfuric acid (CAS 7664-93-9): 10 w/w%,
1-(2-Aminoethyl)piperazine (CAS 140-31-8): neat (99%),
Tetraethylenepentamine (CAS 112-57-2): neat (techn.)

As positive and negative controls, sodium hydroxide (solid) and 10% citric acid were applied in parallel to each test/reference substance.

Control samples:

yes, concurrent no treatment

yes, concurrent positive control

Duration of treatment / exposure:

different: Time that is required for the test article to break through the Corrositex Biobarrier Membrane and produce a change in the Chemical Detection System was measured.

Irritation / corrosion parameter:

other: break through time (min)

Value:

3.15

Vehicle controls validity:

valid

Positive controls validity:

valid

Qualification screen:

The test substance and the three reference chemicals produced a color change in the Chemical Detection System within the required time. Thus they were compatible with the assay.

Categorization screen:

The categorization screen showed the following results:

Test article: Cat. 1

Sulfuric acid: Cat 2

1-(2-Aminoethyl)piperazine: Cat. 1

Tetraethylenepentamine: Cat. 1

The evaluation was performed according to the following table for Category 1 and 2 substances, respectively:

	Corrositex Reaction Time
Cat. 1	0 - 3 min	> 3 < 60 min	> 60 < 240 min	> 240 min
Cat. 2	0 - 3 min	> 3 < 30 min	> 30 < 60 min	> 60 min
PG	I	II	III	not corrosive

PG = Packing Group (PG I = GHS 1A; PG II = GHS 1B, PG III = GHS 1C)

Corrositex Assay:

	Break Through Time (min:sec)
Test Article	Vial 1	Vial 2	Vial 3	Vial 3	Mean
05/0042-2	4:30	2:26	2:45	2:40	3:09
Evaluation according to Category 1:	PG II	PG I	PG I	PG I	PG I
Controls:
PC: Sodium hydroxide, solid	14:50	-	-	-	PG II
NC: 10% citric acid	NB	-	-	-	-

PG = Packing Group; NC = Negative Control; - = not applicable, NB = No Break Through, PC = Positive Control

Sodium hydroxide (solid, PC) showed reaction times between 10 and 20 min after application and was assigned to PGII, accordingly.

The negative control did not produce any reactions within 60 min after application. Thus, the controls fulfill the acceptance criteria and demonstrate the validity of the assay.

The reference chemicals sulfuric acid (10%) and 1-(2-Aminoethyl)piperazine (neat, 99%) were both correctly assigned to PGII.

For the third reference chemical (Tetraethylenepentamine (neat, techn.)) PGIII was expected. Although the chemical produced break through times at the border from PGII to PGIII the results of all four vials lead to a false assignment to PGII.

For the test substance break through times between 2:26 and 4:30 minutes were obtained, spanning the border of PGI and PGII classification and producing a mean break through time slightly above 3 minutes. However, as the reaction times of 3 vials were below the border of 3 minutes after application, the test substance had to be assigned to PGI in total.

Interpretation of results:

Category 1A (corrosive) based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Draize Test (Federal Register 38, No. 187 § 1500.42 (eye), p. 27019, 23.09.1973):
0.10 mL of the test substance were applied to the conjunctival sac of one eye in each of 6 rabbits. The animals were observed after 1, 24, 48 and 72 h and 7 d after installation. The eyes were not washed out.

GLP compliance:

no

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3 - 4 kg
- Housing: individually
- Diet: standard pellet feed for rabbits ad libitum
- Water: ad libitum
- Acclimation period: > 3 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23 °C
- Humidity (%): 50 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

see Observation period (no washing conducted)

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

SCORING SYSTEM: according to Draize

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

(animal 1-6)

Time point:

24/48/72 h

Score:

3.4

Max. score:

4

Reversibility:

not reversible

Remarks:

(within 7 days)

Remarks on result:

other: 5 animals with a corneal opacity score of 4 at the end of the observation period;

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(animal 1 - 6)

Time point:

24/48/72 h

Score:

3.4

Max. score:

4

Reversibility:

not fully reversible within: 72 h (7 days after instillation: no data)

Remarks on result:

other: 7 days post application: purulent conjunctivae, in part necrotic with nasty smell; no chemosis score could be therefore determined on day 7;

Irritation parameter:

iris score

Basis:

mean

Remarks:

(animal 1 - 6)

Time point:

24/48/72 h

Score:

1.5

Max. score:

2

Reversibility:

not fully reversible within: 72 h (7days after instillation: no data)

Remarks on result:

other: 7 days post application: purulent conjunctivae, in part necrotic with nasty smell; no iritis score could be therefore determined on day 7;

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(animal 1 - 6)

Time point:

24/48/72 h

Score:

1.1

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: Due to substance staining assessment not possible for animal 1, 3, 5, 6, 24 and 48 h after instillation. The mean was only calculated for the available scores.

Irritant / corrosive response data:

The application of the test substance led initially to defense movement, pain cries and tightly shutting of the eyes. 24 h post application the eye was agglutinated by purulence and purulent discharge was noted. 7 days post application purulent conjunctivae, in part necrotic with nasty smell; 5 animals still showed corneal opacity score 4.

Findings:

animal 1/2/3/4/5/6

Time	Opacity	Iritis	Erythema	Chemosis	Secretion
24 h	4/2/4/2/4/4	2/0/2/0/2/2	#/2/#/2/#/#	3/4/3/2/2/2	0/2/2/2/1/2
48 h	4/2/4/2/4/4	2/0/2/0/2/2	#/2/#/2/#/#	4/4/4/3/4/4	1/2/2/2/3/3
72 h	4/3/4/3/4/4	2/2/2/1/2/2	0/2/0/1/0/0	4/4/4/3/4/4	2/2/2/2/2/2

#: due to substance staining assessment not possible.

Irritation Index >/= 88.3 (max. 110)

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Additional information

Skin irritation:

In a primary dermal irritation study (BASF AG 1980), Vienna White rabbits (2 animals for each exposure period) were dermally exposed to the unchanged test substance for 3 min or 1 hour under occlusive conditions. Animals then were observed for 8 days. Irritation was scored according to the method of Draize. Severe erythema, moderate edema and full thickness necrosis were observed (both at 3 min and 1 h exposure) in all animals until the end of the observation period. Hence, all symptoms were not reversible and referred to a corrosive potential of the test substance.

In a second primary dermal irritation study (BASF AG 1977), six rabbits were dermally exposed to 0.5 mL of the unchanged test substance for 24 hours under occlusive conditions. Animals then were observed for 7 days. Irritation was scored according to the method of Draize. This study confirmed the corrosive potential of the test substance. Leathery and dry skin with a red-brown-blackish discoloration was found. At necropsy 5 animals showed reddening of the cutaneous tissue which extended in 3 animals into the muscular system. 2 animals showed necrosis with partially jelly consistency.

Additionally, two in vitro tests were performed. In the EpiDerm Test according to OECD 431 the test substance showed a severe corrosive potential (BASF 2010). In the Corrositex test according to OECD 435 the chemical produced break through times that would justify classification as GHS, Category 1A in three out of four vials. In the last vial the break-through time would just lead to GHS category 1B. (BASF 2009).

 

Eye irritation:

 

In a primary eye irritation study (BASF AG 1980), 0.1 mL of the unchanged test substance was instilled into the conjunctival sac of six rabbits (without washing). Animals then were observed for 7 days. Irritation was scored by the method of Draize. Initially, the application led to pain cries and tightly shutting of the eyes.The test substance caused corrosion to the exposed eyes predominantly expressed by heavy opacity (mean of 6 animals (24 - 48 - 72 h): 3.4), iritis (mean of 6 animals (24 - 48 - 72 h): 1.5), chemosis (mean of 6 animals (24 - 48 - 72 h): 3.4) and necrosis of the conjunctiva (7 days after exposure).

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 1272/2008. As a result, the substance is classified for skin irritation/corrosion Cat. 1A and eye irritation Cat. 1 under Regulation (EC) No. 1272/2008, as amended for the fifteenth time in Regulation (EC) No. 2020/1182.