Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to OECD Guideline 431 (adopted 2004)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 431
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
(Laus GmbH)

Test material

Constituent 1
Reference substance name:
Cumene bottoms (benzene, (1-methylethyl)-, distn. residues)
IUPAC Name:
Cumene bottoms (benzene, (1-methylethyl)-, distn. residues)
Details on test material:
Batch number 341309
Yeliowish Liquid.
UVCB substance (Benzene, (1-methylethyl)-, distn. Residues)
CAS No 68936-98-1
This substance is an UVCB. Under this definition, no components can be considered as impurities (purity 100%)

Test animals

Species:
other: in vitro model using human-derived epidermal keratinocytes
Strain:
other: not applicable
Details on test animals or test system and environmental conditions:
highly differentiated model of the human epidermis

Test system

Type of coverage:
other: in vitro
Preparation of test site:
other: in vitro
Vehicle:
unchanged (no vehicle)
Controls:
other: Deionised water was used as negative control, 8 m KOH was used as positive control
Amount / concentration applied:
50 µL
Duration of treatment / exposure:
3 minutes or 1 hour
Number of animals:
For each experiment ("3 minutes" and "1 hour"), two 6-well-plates were used.

Results and discussion

Any other information on results incl. tables

After treatment with the negative control, the absorbance values were well above the required acceptability criterion of mean OD > 0.8 for both treatment intervals. The positive control showed clear corrosive effects for both treatment intervals. After three minutes treatment with the test item, the relative absorbance values were reduced to 98.1 %. This value is well above the threshold for corrosion potential (50%). After one hour treatment, relative absorbance values were increased to 108.8 %. This value is also above the threshold for corrosion potential (15%).

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive in human skin model test