Registration Dossier
Registration Dossier
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EC number: 238-122-3 | CAS number: 14246-53-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 14th -March 23rd 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: not in accordance With the GLP guidelines (Prior to GLP)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: BIOGIR SA Protocole SMK
- Principles of method if other than guideline:
- Skin sensitization , adopted from Magnusson and Kligman maximisation assay, 15 treated Guinea pigs observed at 24 and 48 h, powder substance.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test performed in 1991.
LLNA method (OECD 442 B) was adopted in 2010.
Test material
- Reference substance name:
- N-(1-oxooctyl)glycine
- EC Number:
- 238-122-3
- EC Name:
- N-(1-oxooctyl)glycine
- Cas Number:
- 14246-53-8
- Molecular formula:
- C10H19NO3
- IUPAC Name:
- N-(1-oxooctyl)glycine
- Reference substance name:
- LiPACIDE CG
- IUPAC Name:
- LiPACIDE CG
- Details on test material:
- - Name of test material (as cited in study report): LIPACIDE CG
- Substance type: substance mono constituant
- Physical state: solid
- Analytical purity: 99%
- Lot/batch No.: 89303001
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- 350g prior the test
identifying by individual picric acid
the animals received tap food and water
air conditionned: 14cycles per hour
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: vaselin oil
- Concentration / amount:
- 25 and 12.5%
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: vaselin oil
- Concentration / amount:
- 25 and 12.5%
- No. of animals per dose:
- 15
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 30
- Exposure period: 48h
- Test groups: 15
- Control group: 15
- Site: scarified skin area
- Concentrations: 25% and 12.5%
B. CHALLENGE EXPOSURE
- No. of exposures: 30
- Day(s) of challenge: 28
- Exposure period: 24h
- Test groups: 15
- Control group: 15
- Site: scarified skin area
- Concentrations: MNIC and 1/2 MNIC
- Evaluation (hr after challenge): 24h
- Challenge controls:
- 15 animals treated with Vaselin oil
- Positive control substance(s):
- yes
- Remarks:
- vaselin oil
Results and discussion
- Positive control results:
- not mentioned in the report
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Clinical observations:
- no reaction
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: no reaction.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Clinical observations:
- no reaction
- Reading:
- other: not performed
- Group:
- positive control
- Dose level:
- Not applicable
- Clinical observations:
- N/A
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- under the experimental conditions employed , the product LIPACIDE CG did not induce any macroscopic reaction which could be related to a sensitization in the albino guinea pig. The product may be therefore consiedered as hypoallergenic
- Executive summary:
Test item: no animal sensitised at either concentration.
Negative controls: no animal sensitised, confirming test system specificity.
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