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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- a temperature of 18°C was registered during this study instead of 19°C (minimal limit) as planned in the experimental protocol. This deviation did not, in any cas, influe,ce the development and the result of the study
- Principles of method if other than guideline:
- N/A
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This Guinea pig maximisation test realised in 2002 before the publication of the Murine Local Lymph Node Assay (LLNA) Performance standards by ECVAM in 2008.
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Source: Centre de Production animale (F-45160 OLIVET)
Weight: about 261 to 354 g at the time of trial
Acclimatation: at least 5 days in the animal house of laboratory.
Housing: the animals are housed either in groups of 2 or 3 in makrolon containers, the flooring of which is covered with dust-free cuttings and the top fitted a stainless steel lid with a feeding device and drinking device of 500ml. These cages are placed in temperature controlled animal shelter where the temperature is between 18 and 23°C and the relative humidity is maintained at between 38 and 56%
Food: aliment réf: 114, UAR - Villemoisson 91360 VILLEMOISSON SUR ORGE
Water: tap water from public distribution system.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 1st induction:
- 2 intrdradermal injections of the product at 100%
- 2 intrdradermal injections of Freunds's complete adjuvant (50% dilution in the physicological saline solution)
- 2 injections of mixture with equal volumes - Freunds's complete adjuvant at 50% and the product at 100%
2nd induction:
- topical application on the same zone with the product at 100%, 24 hours after brushing with 0.5 ml of a solution of Sodium Lauryl sulfate at 10% - Day(s)/duration:
- 8 days
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 100% and 50% (1/2 MNIC)
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Preliminary studies:
2 females to determine the MNNC
2 females to determine the pre-MNIC
2 females to determine the MNNC
Main study
Group 1 (negative control): 5 females
Group 2 (treated): 10 females - Details on study design:
- Preliminary study:
- Determination of the Maximum Non Necrotizing concentration: MNNC
The test product was injected by intradermal route at the following concentrations: 100%, 50%, 25%, 12.5%, 6.25%, 3.125% diluted in a physiological saline solution
- Determination of the pre- Maximum Non Irritant concentration: pre-MNIC
The test product was applied under an occlusive dressing during 24 hours at the following concentrations: 100%, 50%, 25%, 12.5% diluted in a physiological saline solution
- Determination of the Maximum non-irritant concentration:
After induction by intradermal injection with physiological saline solution and by topical application with distilled water and a 17-days rest phase, the challenge phase under occlusive dressing for 24 hours consists in a single topical application of the test product at the following concentration 100%, 50%, 25%, 12.5% diluted in a physiological saline solution - Challenge controls:
- Group 1 (negative control): 5 females
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No cutaneous intolerance reaction was recorded in animals from the negative control group
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No cutaneous intolerance reaction was recorded in animals from the negative control group
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No macroscopic cutaneous reactions attributable to allergy was recorded during the examination following the removal of the occlusive dressings (challenge phase).
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No macroscopic cutaneous reactions attributable to allergy was recorded during the examination following the removal of the occlusive dressings (challenge phase).
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In view of the results, under the experimental conditions, the product mot not classified in accordance with the criteria for classification, packaging and labelling of dangerous substances of the E.E.C. Directives 67/548 and 99/45.
- Executive summary:
The test item was tested according to the OECD 406 guidelines.
In view of the results, under the experimental conditions, the product mot not classified in accordance with the criteria for classification, packaging and labelling of dangerous substances of the E.E.C. Directives 67/548 and 99/45.
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