Registration Dossier
Registration Dossier
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EC number: 206-229-4 | CAS number: 312-84-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- At the time that the study was conducted the M&K maximisation method was considered to be the most widely accepted for worldwide regulatory purposes.
Test material
- Reference substance name:
- D-serine
- EC Number:
- 206-229-4
- EC Name:
- D-serine
- Cas Number:
- 312-84-5
- Molecular formula:
- C3H7NO3
- IUPAC Name:
- D-serine
- Test material form:
- solid
- Details on test material:
- - Appearance: white solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: K0498003
- Expiration date of the lot/batch: October 2005
- Purity: 100%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (storage temperature: from 16 to 25°C), dark place
- Stability: Stable under the storage conditions
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6 weeks
- Weight at study initiation: 303 to 356 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Concentration / amount:
- 10%w/v
- Adequacy of induction:
- other: maximum concentration at which there was no necrosis.
- Route:
- intradermal
- Vehicle:
- other: Freund’s Complete Adjuvant and water
- Concentration / amount:
- 1:1
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- other: test solution and Freund’s Complete Adjuvant
- Concentration / amount:
- 20 w/v% Test solution and Freund’s Complete Adjuvant
- Adequacy of induction:
- not specified
- Route:
- other: Percutaneous
- Vehicle:
- not specified
- Concentration / amount:
- 50 w/v% Test solution
- Adequacy of induction:
- highest technically applicable concentration used
Challengeopen allclose all
- No.:
- #1
- Route:
- other: not specified
- Vehicle:
- not specified
- Concentration / amount:
- 50 w/v% Test solution
- Day(s)/duration:
- On day 20 after induction of sensitization
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- other: not specified
- Vehicle:
- not specified
- Concentration / amount:
- 5 w/v% Test solution
- Day(s)/duration:
- On day 20 after induction of sensitization
- Adequacy of challenge:
- not specified
- No.:
- #3
- Route:
- other: not specified
- Vehicle:
- not specified
- Concentration / amount:
- 0.5 w/v% Test solution
- Day(s)/duration:
- On day 20 after induction of sensitization
- Adequacy of challenge:
- not specified
- No.:
- #4
- Route:
- other: not specified
- Vehicle:
- not specified
- Concentration / amount:
- 0.05 w/v% Test solution
- Day(s)/duration:
- : On day 20 after induction of sensitization
- Adequacy of challenge:
- not specified
- No.:
- #5
- Route:
- other: not specified
- Vehicle:
- not specified
- Concentration / amount:
- 0.005 w/v% Test solution
- Day(s)/duration:
- On day 20 after induction of sensitization
- Adequacy of challenge:
- not specified
- No.:
- #6
- Route:
- other: not specified
- Vehicle:
- not specified
- Concentration / amount:
- Water for injection
- Day(s)/duration:
- On day 20 after induction of sensitization
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Test article sensitization group: 10 animals
Test article non-sensitization group: 5 animals - Details on study design:
- Intradermal induction: 10 w/v% (maximum concentration)
Percutaneous induction: 50 w/v% (maximum physically administrable concentration)
Challenge exposure: 0.005, 0.05, 0.5, 5, 50 w/v% ( maximum non-irritating concentration) - Challenge controls:
- The skin was observed for skin reactions at 24 and 48 hours after removal of the application for challenge exposure, and erythema and edema graded based on the Standards of Magnusson & Kligman:
Severity of Skin Reactions Grade
No visible change 0
Discrete or patchy erythema 1
Moderate and confluent erythema 2
Intense erythema and swelling 3 - Positive control substance(s):
- yes
- Remarks:
- Historical background data of the positive control article
Results and discussion
- Positive control results:
- No positive control groups were provided in this study: historical background data of the positive control article (MBT: Mercaptobenzothiazole) using the same strain of guinea pigs were obtained at the test facility (April 7, 2004 to March 8, 2005) and it has been confirmed that the experimental technique of the test facility was appropriate and there is no problem in the susceptibility of the guinea pigs used in this study.
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 w/v%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: the substance is not a skin sensitiser
- Conclusions:
- Based on the results described above, it was concluded that the test substance had no skin sensitization effects under the conditions of this study.
- Executive summary:
The skin sensitisation potential of the test material was investigated in a GLP study which was conducted in accordance with the standardised guideline OECD 406 following guinea pig maximisation test methods.
Under the conditions of the study there were no skin reactions in the observation at 24 or 48 hours after removal of challenge application in any test group during the observation period.
In the general condition and body weight, there were no abnormalities that are thought to be effects from administration of the test material in any test group during the observation period.
Based on the results described above, it was concluded that the test material had no skin sensitisation effects under the conditions of this study.
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