Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July to December 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: in-vitro study performed according to OECD guideline and under GLP conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Absorbent N grade A
IUPAC Name:
Absorbent N grade A
Details on test material:
- Name of test material (as cited in study report): Absorbent N grade A
- Substance type: UVCB
- Physical state: Brown liquid
- Stability under test conditions: months
- Storage condition of test material: room temperature, in the dark

Test animals

Species:
human

Results and discussion

Any other information on results incl. tables

Viability

 

 

Test Item

3 minutes

Test Item

60 minutes

Viability (Vitality) / Mean [%]

 

94.9

 

61.1

In accordance to the OECD Guideline 431 a test item is considered to be corrosive to skin

  • if the viability after 3 minutes exposure is less than 50 %. or
  • if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15 %.

Thereafter the test item “Absorbent N Grade A” was considered to be non-corrosive to skin according to OECD Guideline 431. The positive controls proveadditionally the well functioning of the skin models.

Applicant's summary and conclusion

Interpretation of results:
other: non-corrosive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
According to the definition of the OECD-Guideline 431 the test item was considered to be non-corrosive.
Executive summary:

The aim of this study was the detection of a corrosion potency of „Absorbent N Grade A“ tested on a Human Skin Model.

According to the definition of skin corrosion, inserts were incubated with the specimen for 3 min and 1 h. To avoid an evaporation during incubation all inserts were covered with a tin foil. After the indicated time the inserts were rinsed thoroughly with PBS. Finally, cell viability was measured by performing a standard MTT assay.

Viability was determined to be 94.9% after 3 min and 61.1% after 1h.

According to the definition of the OECD-Guideline 431 the test item is considered to be non-corrosive.