Registration Dossier
Registration Dossier
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EC number: 700-887-0 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted with a supporting substance, but according to the OECD guideline 406 and is fully GLP-compliant. As no study for the reaction mass of L-alanyl-L-glutamine and potassium chloride is available, studies conducted with the two main components L-alanyl-L-glutamine and potassium chloride (such as this) were used for read-across in order to avoid unnecessary repetition of testing. As no synergistic or antagonistic effects from either of the main components is expected, the information derived from both main components separately is considered to be reliable for classification of the reation mass of L-alanyl-L-glutamine and potassium chloride.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This skin sensitization study was conducted in 1994. The guideline for the LLNA method was adopted in 2002 and was therefore not available in 1994.
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd/Win: DH
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan-Winkelmann GmbH
- Age at study initiation: males 9 weeks; females 9 weeks
- Weight at study initiation: males 493-533 g; females 419-469 g
- Housing: individually in Macrolon cages type IV
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.0 - 19.5
- Humidity (%): 52-70
- Photoperiod: 12 hrs dark / 12 hrs light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- intradermal induction: 1%
epicutaneous induction: 50%
epicutaneous challenge: 30%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- intradermal induction: 1%
epicutaneous induction: 50%
epicutaneous challenge: 30%
- No. of animals per dose:
- control group: 6 animals
treatment group: 10 animals - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
intracutaneous application
- No. of exposures: 1
- Test groups: 2 x FCA/physiological saline solution (1:1); 2 x test substance solution; 2 x test substance solution/ FCA (1:1)
- Control group: 2 x FCA/physiological saline solution (1:1); 2 x 0.9% phyiological saline solution; 2 x 0.9% phyiological saline solution/ FCA (1:1)
- Site: area of 4 x 6 cm of the scapular region
- Concentrations: 1%
epicutaneous application
- No. of exposures: 1
- Test group: test substance in 0.9 % physiological saline solution
- Control group: 0.9 % physiological saline solution
- Site: vehicle => right flank; test substance => left flank
- Duration: 48 hours
- Concentrations: 50%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 22
- Exposure period: 48 h
- Test group: test substance in 0.9 % physiological saline solution
- Control group: test substance in 0.9 % physiological saline solution
- Site: vehicle => right flank; test substance => left flank
- Concentrations: 30%
- Evaluation (hr after challenge): 24 and 48 hrs - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions used in this study the test substance showed no sensitizing potential.
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