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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:
key study
Study period:
60 minutes exposure with 42 hour post exposure incubation
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Guideline study to GLP
Acetate salt is seen as a suitable surrgoate for citrate; the two acids are similar and are both water soluble under the conditions of testing
Citric acid is not classified as irritant to skin.

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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Batch RGA16-5628

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Justification for test system used:
This in-vitro model is considered a suitable substitute for live animals
Vehicle:
unchanged (no vehicle)
Details on test system:
Test item - single application of nominal 25 mg on top of each tissue (tissues pre-wetted with 25μl PBS)
Reference items – single application 30 μl of negative control (PBS) or positive control (SDS 5%).
Three tissues were used per condition (n=3).
Control samples:
yes, concurrent positive control
yes, concurrent MTT non-specific colour control
Amount/concentration applied:
25 mg applied neat to wetted surface
Duration of treatment / exposure:
60 minutes
Duration of post-treatment incubation (if applicable):
42 hours
Number of replicates:
3

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1
Value:
59
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
The test item did not reduce the viability to 50% or below and should be considered as non-Irritant.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item did not reduce the viability to 50% or below and should be considered as non-Irritant.
Executive summary:

Valid study confirming that the criteria to classify as irritant were not met. However, there was some reduction in viability suggesting a weak irritation potential