Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin
other:
Justification for type of information:
Due to the nature and type of the substance indicates that not toxicity by dermal route is expected, for this reason and for the wellfare of the animals this tests is not conducted.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
Treatment duration was 4 hours.
Observation period:
The skin reaction was assessed at approximately 1, 24, 48 and 72 hours after exposure
Number of animals:
3
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hrs
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Other effects:
no other effects
No abnormalities were detected in the skin of any animal in any of the observation times and hence the 72 hours was considered the end of the observation period in all animals.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study and referring to the classification criteria (Commission Directive 2001/59/EC of 6 August 2001), the product is considered as "NO IRRITANT" on the skin of rabbits, it is not necessary to assign risk notation.
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Name:
no classification/labelling required (no dangerous properties)
Not classified
Implementation:
EU
Related composition:
Protein hydrolyzates, animal
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
hazard class not assessed
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data lacking
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Signal word:
No signal word

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion