Registration Dossier

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 feb 2017 to 03 May 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid

In vitro test system

Test system:
artificial membrane barrier model
Remarks:
Reconstituted collagen matrix, constructed to have physico-chemical properties similar to rat skin
Source species:
other: Reconstituted collagen matrix, constructed to have physico-chemical properties similar to rat skin
Vehicle:
unchanged (no vehicle)

Test animals

Species:
other: Reconstituted collagen matrix, constructed to have physico-chemical properties similar to rat skin

Test system

Type of coverage:
other: In vitro
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
Single Exposure

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
1
Value:
ca. 12.26
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation

Any other information on results incl. tables

The positive control, 1.0 N Sodium Hydroxide, was categorized as received and the negative control, Citric Acid, was used as a 10% solution in water. The results of both controls were considered valid.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
The material was considered moderately corrosive. The material was classified in Packing Group II of GHS Subcategory 1B.
Executive summary:

The reaction mass of 4- Sulphophthalic acid (CAS 89 -08 -7) and 3- sulphophthalic acid (CAS 67892 -43 -7), 3:1 ratio was determined to be compatible with the Corrositex® system. Then, a formulation of 10% test material in water 100 uL test material : 900 uL tissue culture water) was categorized by pH to determine Category 1 cut-off times should be used to determine corrosivity. 0.5 mL of the test article was added to each of four Corrositex® test vials containing biobarriers and the times required for the test article to permeate or destroy the biobarriers were recorded. A positive control (1.0 N sodium hydroxide) and a negative control (1% citric acid) was tested concurrently. The average breakthrough time for the four test material samples was 12.26 minutes. The test material was considered moderately corrosive.