Registration Dossier
Registration Dossier
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EC number: 425-980-0 | CAS number: 129499-78-1
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:
- other: GLP complianced.
Data source
Reference
- Reference Type:
- other: Inquiry result from ECHA
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 92/69/CEE, B.6
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 425-980-0
- EC Name:
- -
- Cas Number:
- 129499-78-1
- Molecular formula:
- C12H18O11
- IUPAC Name:
- L-Ascorbic acid 2-glucoside
Constituent 1
In vivo test system
Test animals
- Species:
- other: Cochon d'lnde, lbm: GOHI; SPF
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
INTRADERMIQUE : 0.1 ml:
1) FCA a 1:1 avec de la solution saline physiologique
2) 1% dans de l'eau bidistillee
3) 1% dans um melange de FCA a 1:1 avec de la solution
saline physiologique
EPIDERMIQUE:
75% dans de l'eau bidistillee
Concentration of test material and vehicle used for each challenge:
EPIDERMIQUE:
75% dans de l'eau bidistillee
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
INTRADERMIQUE : 0.1 ml:
1) FCA a 1:1 avec de la solution saline physiologique
2) 1% dans de l'eau bidistillee
3) 1% dans um melange de FCA a 1:1 avec de la solution
saline physiologique
EPIDERMIQUE:
75% dans de l'eau bidistillee
Concentration of test material and vehicle used for each challenge:
EPIDERMIQUE:
75% dans de l'eau bidistillee
- No. of animals per dose:
- Number of animals in test group : 20
Number of animals in negative control group : 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test : 75%
Signs of irritation during induction:
- 1/20 animaux a montre un erytheme apres l'exposition epidermique.
- Application a J7 de laurylsulfate de sodium
Evidence of sensitisation of each challenge concentration:
75% : 0/20 (0%) animaux presentant une sensibilisation
Other observations:
MORTALITE:
On a trouve un animal du groupe temoin negatif mort au jour
18 et observe des modificaitons macroscopiques des poumons.
La mort n'est pas liee au traitment.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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