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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2014-12-09 to 2015-03-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Experimental study according to guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
2013
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

Test material

Constituent 1
Chemical structure
Reference substance name:
1-chloro-4-[(prop-2-yn-1-yloxy)methyl]benzene
EC Number:
813-130-5
Cas Number:
4039-86-5
Molecular formula:
C10H9ClO
IUPAC Name:
1-chloro-4-[(prop-2-yn-1-yloxy)methyl]benzene

Test animals

Species:
human
Details on test animals or test system and environmental conditions:
Kits used:
- EpiDerm™ 200 kit (Lot: 21607)
- 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
- Tissue for MTT reduction control: Epi-200 tissue that is killed by freezing at –20°C

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: negative, positive and MTT-reduction control
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"

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: viability
Value:
40.3
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 1 h exposure, 42 h post-exposure. Reversibility: other: not applicable. Remarks: %. (migrated information)

Any other information on results incl. tables

Test substance

 

 

Tissue 1

Tissue 2

Tissue 3

Mean

SD

CV [%]

Negative control

Viable tissues

Mean OD570

2.304

2.649

2.488

2.480

0.173

 

Viability [% of NC]

92.9

106.8

100.3

100.0

7.0

7.0

KC tissues

Mean OD570

0.062

0.066

0.055

0.061

0.005

 

Viability [% of NC]

2.5

2.6

2.2

2.4

0.2

8.7

Test substance

Viable tissues

Mean OD570

0.812

0.986

1.198

0.999

0.193

 

Viability [% of NC]

32.7

39.8

48.3

40.3

7.8

19.4

KC tissues

Mean OD570 corrected

0

0

0

0

0

 

Viability [% of NC]

0

0

0

0

0

-

Positive control

Viable tissues

Mean OD570

0.063

0.068

0.072

0.067

0.005

 

Viability [% of NC]

2.5

2.7

2.9

2.7

0.2

7.1

Negative values were set to zero for further calculation

CV=coefficient of variation

SD=standard deviation

Due to the ability of the test substance to reduce MTT directly, KC tissues were applied in parallel. However, the result of the KC did not indicate an increased MTT reduction. Thus the mean viability is given without KC correction.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information