Registration Dossier
Registration Dossier
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EC number: 271-770-5 | CAS number: 68607-88-5 Substance obtained by acidic, alkaline, or enzymatic hydrolysis of soya composed primarily of amino acids, peptides, and proteins. It may contain impurities consisting chiefly of carbohydrates and lipids along with smaller quantities of miscellaneous organic substances of biological origin.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- N/A
- GLP compliance:
- yes
Test material
- Reference substance name:
- Protein hydrolyzates, soya
- EC Number:
- 271-770-5
- EC Name:
- Protein hydrolyzates, soya
- Cas Number:
- 68607-88-5
- IUPAC Name:
- Enzymatic hydrolysis products of Glycine soya
- Test material form:
- liquid
- Details on test material:
- Amber liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Source: The Elevage de Gérome (40260 Linxe)
- Weight at study initiation: about 2.5 to 2.85 kg at the time of trial
- Housing: Animals were kept in individual boxes of standardized dimensions .
These cages are placed in a temperature controlled animal shelter where the temperature is between 19°C and 22°C and the relative humidity is maintained at between 46% and 51%.
- Foodstuff: ref 112; UAR - 91360 VILLEMOISSON SUR ORGE
- Water : Tap water from public distribution system
- Acclimation period: 5 days at least
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 ml of pure product
- Duration of treatment / exposure:
- the dressing is removed after 4 hours
- Observation period:
- The irritation is measured 1 hour after removing the dressing, then the rating is repeated at hour 24 hours, 48 hours, 72 hours.
- Number of animals:
- 3 male albinos rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No cutaneous reactions (erythema or oedema) were observed in any animal whatever the examination time.
- Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results obtained in the experimental conditions, enabled to conclude that the test product, according to th scales of interpretation retained:
- is non irritant to skin (PSi=0) according to the classification established in the Journal Officiel de la République Française dated February 21, 1982.
- and must not be classified according to the criteria of classification, packaging and labelling of dangerous substances in compliance with the E.E.C Directive 67/548 and 99/ 45 - Executive summary:
The test item was administered pure to 3 New Zealand rabbits at the dose of 0.5 ml.
The results obtained in the experimental conditions, enabled to conclude that the test product, according to th scales of interpretation retained:
- is non irritant to skin (PSi=0) according to the classification established in the Journal Officiel de la République Française dated February 21, 1982.
- and must not be classified according to the criteria of classification, packaging and labelling of dangerous substances in compliance with the E.E.C Directive 67/548 and 99/ 45
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