Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Referenceopen allclose all

Reference Type:
other company data
Title:
Unnamed
Year:
2009
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Version / remarks:
13 April 2004
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
impurity
Specific details on test material used for the study:
substance CS at 5 % in MBIK and hexyl acetate solvents used (no dimetyl glutarate as mentioned in test material)

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
other: epidermis cells
Cell source:
other: Not specified
Source strain:
other: human
Details on test system:
Episkin™ Reconstituted Human Epidermis Model
Amount/concentration applied:
5% in solvents MBIK or hexyl acetate
Duration of treatment / exposure:
3, 60, 240 minutes
Duration of post-treatment incubation (if applicable):
Not specified
Number of replicates:
Not specified

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
5% test material in hexyl acetate - exposure period 240 minutes
Value:
ca. 97.4
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: non corrosive
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
5% test material in MBIK - exposure period 240 minutes
Value:
ca. 97.4
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: non corrosive
Other effects / acceptance of results:
relative mean viability for positive control was 7.3% relative to the negative control treated tissues following 240 minutes exposure period: validity criterion satisfied

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The results showed that the substance CS at 5% in either hexyl acetate or MIBK or dimethyl glutarate solutions is non-corrosive.
Executive summary:

According to study using Episkin Reconstituted Human Epidermis Model. which methodology follows OECD 431 standard, the results showed that the substance CS at 5% in either hexyl acetate or MIBK or dimethyl glutarate solutions is non-corrosive. The results were published by (Croft, 2003).