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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: A well GLP documented study according to OECD guideline.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
There is number of unifying considerations justifying the similarity between the two substances:
- Similarity of synthesis: the two substances are obtained by an acidic alkaline or enzymatic hydrolysis of protein.
- Similarity of use: the two substances are used in industrial and biotechnological applications as a supplement to cell culture, food for aquatic organisms and animals.
- Similarity of toxicokinetic behavior: the two substances are composed primarily of amino acids which are completely metabolized. Once ingested the two substances follow the same ways of absorption, distribution, metabolism and elimination.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See attached read across justification document)

3. ANALOGUE APPROACH JUSTIFICATION
The read-across substance, as compared to the target substance, is more soluble (1,896 g/L and 8.82 – 28.96 g/L, respectively) and thus provides a conservative read-across due to increased bioavailability.

4. DATA MATRIX
See attached justification document.
Cross-reference
Reason / purpose for cross-reference:
read-across source
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
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:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
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 allanimals.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study on proteines hydrolysates 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. Based on the read across strategy from this supporting substance, peptones casein are considered as well "NO IRRITANT".

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Peptones, casein
EC Number:
293-428-4
EC Name:
Peptones, casein
Cas Number:
91079-40-2
Molecular formula:
Not applicable
IUPAC Name:
Peptones, casein
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Other effects:
no other effects

Any other information on results incl. tables

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 allanimals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study on proteines hydrolysates 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. Based on the read across strategy from this supporting substance, peptones casein are considered as well "NO IRRITANT".

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