Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: BALB/c 3T3 method
Deviations:
no
Principles of method if other than guideline:
BALB/c 3T3 cells were seeded and exposed to tested product in a concentration range. After 24h incubation, Neutral Red Uptake in the lysosomes/endosomes and in vacuoles of living cells was measured and used as quantitative indicator of cell number and viability.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Grape, red, ext.
EC Number:
284-511-6
EC Name:
Grape, red, ext.
Cas Number:
84929-27-1
IUPAC Name:
Grape, red, ext.
Test material form:
solid

Test system

Controls:
yes, concurrent positive control
yes, concurrent negative control

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
ca. 1 000
Negative controls validity:
valid
Remarks:
OD540= 0.801 ± 0.060
Positive controls validity:
valid
Remarks:
NR50= 0.094 ± 0.002 mg/ml
Remarks on result:
other: ORESVISTA results
Remarks:
NR50 > 1000 μg/ml MMAS < 25

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to the study results, the substance Palmitoyl grapevine shoot extract is not not/mild irritant.