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Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
GLP compliance:
yes (incl. certificate)
Test system:
human skin model
Details on test system:
EpiDerm reconstructed human epidermis model (MarTek)
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Irritation / corrosion parameter:
% tissue viability
Value:
> 50
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Remarks:
data source is a publication from China, no information about European GLP
Specific details on test material used for the study:
The aesculin solution was prepared by dissolving a certain amount of aesculin (1.0 mg/mL) in deionized water containing 4% (w/w) of D-mannitol. pH of the formulation was adjusted to 7.4 ± 0.5 by trolamine.
Species:
rabbit
Strain:
New Zealand White
Vehicle:
water
Amount / concentration applied:

- Amount(s) applied (volume or weight with unit): 50µl
- Concentration (if solution): 1mg/ml

:
Duration of treatment / exposure:
7 days
Observation period (in vivo):
1, 2, 4, 24, 48, 72 hours, 7 days
Number of animals or in vitro replicates:
12
Irritation parameter:
cornea opacity score
Basis:
other: all animals
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
other: all animals
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
other: all animals
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: all animals
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Executive summary:

Aesculin solution was well tolerated by the rabbits and no macroscopic signs of tearing, irritation, redness or other toxic effects were observed. Furthermore, there were no obvious histological changes in the ocular tissues, such as inflammatory infiltration, hemorrhage, and necrosis.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification

not classified on experimental data