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Diss Factsheets

Administrative data

Description of key information

Skin: 
The test substance was determined to be not irritating to the skin in in vitro studies (OECD 439 and 431).
Eye irriation
The test substance was determined to be not irritating to the eye in in vitro studies (OECD 437 and 492).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-11-03 to 2015-11-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Experimental study according to guideline and GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
2015
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Version / remarks:
2012
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany
Details on test animals or test system and environmental conditions:
Kits used:
- EpiDerm™ 200 kit (Lot: 23301)
- Source: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia,
- containing: 24 Epi-200 tissues (reconstructed epidermis): surface 0.6 cm² cultured in Millicells® ∅ 1 cm
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 30 µL
- Concentration: undiluted
Duration of treatment / exposure:
1 h
Details on study design:
Please refer to "Any other information on materials and methods".
Irritation / corrosion parameter:
other: other: tissue viability
Value:
95.7
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 1 h exposure . Reversibility: other: not applicable. Remarks: %, test substance. (migrated information)
Irritation / corrosion parameter:
other: other: tissue viability
Value:
100
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 1 h exposure. Reversibility: other: not applicable. Remarks: %, negative control. (migrated information)
Irritation / corrosion parameter:
other: other: tissue viability
Value:
3
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 1 h exposure. Reversibility: other: not applicable. Remarks: %, positive control. (migrated information)

 

Test substance

 

Tissue 1

Tissue 2

Tissue 3

Mean

SD

CV [%]

Negative control

Mean OD570

2.33

2.267

5.599

2.399

 

 

Viability [% of NC]

97.1

94.5

108.3

100.0

7.3

7.3

Test substance

Mean OD570

2.208

2.285

2.394

2.295

 

 

Viability [% of NC]

92.0

95.2

99.8

95.7

3.9

4.1

Positive control

Mean OD570

0.074

0.072

0.072

0.072

 

 

Viability [% of NC]

3.1

3.0

3.0

3.0

0.0

1.6

 

Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-10-15 to 2015-11-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Experimental study according to guideline and GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Version / remarks:
2013
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
Version / remarks:
2010
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 750 µL
- Concentration: undiluted
Duration of treatment / exposure:
10 min
Details on study design:
Please refer to "Any other information on materials and methods".
Irritation parameter:
in vitro irritation score
Run / experiment:
10 min exposure, 2 h post-exposure
Value:
ca. 0
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Opacity

Substance

Cornea No.

Initial opacity

Final opacity

Opacity change

Corrected opacity change

Mean

SD

Test substance

19

4.6

6.1

1.5

0.0

0.0

0.0

20

5.4

9.5

4.1

0.0

21

3.9

4.3

0.4

0.0

Negative control

1

3.1

6.6

3.5

NA

4.1

2.3

2

3.4

10.1

6.7

NA

3

3.4

5.6

2.2

NA

Ethanol (100 %)

4

6.2

35.8

29.6

25.4

25.0

3.2

5

6.1

38.3

32.2

28.1

6

6.2

31.9

25.8

21.6

Dimethylformamid (100 %)

7

3.5

100.1

96.7

95.5

99.4

6.4

8

3.5

112.7

109.3

105.1

9

3.6

108.3

104.7

100.5

 

Permeability

Substance

Cornea No.

Mean OD490

Dilution factor

Mean corrected OD490

Mean

SD

Test substance

19

-0.001

1

0.000

0

0

20

0.000

1

0.000

21

-0.003

1

0.000

Negative control

1

-0.003

1

NA

0

0

2

-0.002

1

NA

3

-0.002

1

NA

Ethanol (100 %)

4

1.162

1

1.162

0.917

0.261

5

0.947

1

0.947

6

0.643

1

0.643

Dimethylformamid (100 %)

7

0.513

1

0.513

0.782

0.245

8

0.992

1

0.992

9

0.842

1

0.842

 

In Vitro Irritancy score (IVIS)

Substance

Cornea No.

Opacity per cornea

Permeability per cornea

IVIS

per cornea

per group

Mean

SD

Test substance

19

0.0

0.000

0.0

0.0

0.0

20

0.0

0.000

0.0

21

0.0

0.000

0.0

Negative control

1

3.5

0.000

3.5

4.1

2.3

2

6.7

0.000

6.7

3

2.2

0.000

2.2

Ethanol (100 %)

4

25.4

1.162

42.9

38.8

6.5

5

28.1

0.947

42.3

6

21.6

0.643

31.3

Dimethylformamid (100 %)

7

92.5

0.513

100.2

111.1

10.1

8

105.1

0.992

120.0

9

100.5

0.842

113.2

 

Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin corrosion

The in vitro Human Skin Model Test with EpiDerm™ study according to OECD 431 was performed to assess the corrosive potential of the test substance. Independent duplicate tissues of EpiDerm were exposed to either the test substance, the negative control (deionised water) or the positive control (8.0 N KOH) for 3 min and 1 hour. 50 μL of the test substance were dispensed directly onto duplicate EpiDerm tissue surface. After exposure of the tissues to the test substance the mean tissue viability was 95.5 % after 3 minutes exposure and 87.8 % after 1 h exposure. Both values did not touch the threshold for corrosivity. Therefore, the test substance was not considered to be corrosive. In conclusion, it can be stated that in this study and under the reported experimental conditions, the test substance was non corrosive to skin and therefore has not be be classified into Category 1 according to EU CLP and UN GHS.

 

Skin irritation

The in vitro Human Skin Model Test with EpiDerm study according to OECD 439 was performed to assess the irritation potential of the test substance. Independent triplicate tissues of EpiDerm were exposed to either the test item, the negative control (PBS) or the positive control (5 % SDS in water) for 1 hour. 30 μL of the test item were dispensed directly onto triplicate EpiDerm tissue surface, and spread to match the surface of the tissue. After exposure of the tissues to the test substance the mean tissue viability was 95.7 % after 1 h exposure. This value did not touch the threshold for irritation. Therefore, the test substance was considered to be not skin irritating. In conclusion, it can be stated that in this study and under the reported experimental conditions, the test substance was not irritating to skin and is therefore not classified according to EU CLP and UN GHS.

 

Eye irritation / corrosion

An in vitro study with fresh bovine cornea was conducted according to OECD 437 to investigate the eye irritation properties of the test substance. After a first opacity measurement of the fresh bovine corneae, the undiluted test substance, the positive and the negative controls were applied to corneae (750 µL) and incubated for 10 min at 32 °C. After the incubation phase the substances were rinsed from the corneae. The corneae were incubated for 2 h at 32 °C in incubation medium, and opacity was measured a second time. After the opacity measurements permeability of the corneae was determined by measuring spectrophotometrically the transfer of sodium fluorescein after incubation in a horizontal position for 90 minutes at 32 °C. The positive controls showed opacity and permeability of the corneae (mean IVIS = 38.8 for ethanol and 111.1 for dimethylformamid). Relative to the negative control, the test substance did not cause an increase of the corneal opacity or permeability. The calculated mean IVIS was 0.0 (threshold for serious eye damage: IVIS > 65). According to OECD 437 the test item is not identified as corrosive or severe irritant.

 

An in vitro study with a three dimensional human cornea model (EpiOcular™) was conducted to investigate the eye irritation properties of the test substance. Independent duplicate tissues of EpiOcular™ were exposed to either the test substance, the negative control (deionised water) or the positive control (Methyl acetate) for 30 min followed by a 2-hours post-incubation period. 50μL of the test substance were dispensed directly onto tissue surface. After exposure of the tissues to the test substance the mean tissue viability was 100.9 %. The values did not touch the threshold for irritation, which is defined to be < 65 %. Therefore, it can be stated that in this study and under the reported experimental conditions, the test substance was non-irritant to the eye.

 

As one in vitro study showed that the test substance is not corrosive or severe irritating to the eye and a second in vitro study that the test substance is in general not irritating it can be concluded that the test substance is not classified as corrosive or irritating to the eye.

 


Justification for selection of skin irritation / corrosion endpoint:
The study showed non-irritating properties of the test substance.

Justification for selection of eye irritation endpoint:
The study showed non-irritating properties of the test substance.

Justification for classification or non-classification

Skin irritation/corrosion

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 amended for the seventh time in Regulation (EC) No 2015/1221. As a result the substance is not classified for skin corrosion or skin irritation.

 

Eye irritation/corrosion

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 amended for the seventh time in Regulation (EC) No 2015/1221. As a result the substance is not classified as corrosive or irritating to the eye.