Registration Dossier
Registration Dossier
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EC number: 274-503-0 | CAS number: 70247-74-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 January 1994 - 17 May 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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:
- Data from a reliable in vivo test conducted before the enforcement of Commission Regulation (EU) 640/2012 of 06 July 2012 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) are available.
Reason for selection
The maximisation test has been selected , because i t is one of the recommended tests in th e OECD guidelin e 406, adopted May 12, 1981, adapted July 17, 1992, a s well a s in Annex V, Part B
of Council Directiv e 67/548/EEC (Commission Directive 92/69/EEC of Jul y 31, 1992), and because the sensitivit y of the method is well known. The test has been performed in essence according to the origina l protoco l of Magnusson and Kligman (J. invest .Dermatol. 52, 268-276, 1969; Contac t Dermatitis 6, 46-50,1980).
Test material
- Reference substance name:
- Sodium bis[N-(2-chlorophenyl)-2-[[2-hydroxy-5-(N-methylsulphamoyl)phenyl]azo]-3-oxobutyramidato(2-)]cobaltate(1-)
- EC Number:
- 274-503-0
- EC Name:
- Sodium bis[N-(2-chlorophenyl)-2-[[2-hydroxy-5-(N-methylsulphamoyl)phenyl]azo]-3-oxobutyramidato(2-)]cobaltate(1-)
- Cas Number:
- 70247-74-4
- Molecular formula:
- C34H30Cl2CoN8O10S2.Na
- IUPAC Name:
- sodium bis[N-(2-chlorophenyl)-2-[[2-hydroxy-5-(N-methylsulphamoyl)phenyl]azo]-3-oxobutyramidato(2-)]cobaltate(1-)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- Code number: FAT - 20'035/C
EN-Nr.: 140200.31
Appearance: solid
Solubility: 20g/l [in water]
Storage: room temperature
Expiration date: 10/98
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Weight at study initiation:310 to 449 g.
- Housing: The animals were housed individually in Macrolon cages (Type 3)
- Diet: ad libitum standard guinea pig pellets -NAFAG No. 845, Gossau SG
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%):30 to 70
- Photoperiod (hrs dark / hrs light): a 12 hours light cycle day.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5 % / 0.1 ml
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 50 % / patch 2x4 cm; approx. 0.4 g per patch
- Day(s)/duration:
- Day 8
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 30 % / patch 2x2 cm; approx. 0.2 g per patch
- Day(s)/duration:
- Day 21
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 5 per sex
- Details on study design:
- Test procedure:
DAY 0: INDUCTION, intradermal injections
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the left and right side of the shaved neck of the test and control group animals.
Test group:
- adjuvant/saline mixture 1:1 (v/v)
- 5 % FAT 20035/C in physiological saline (w/v)
- 5 % FAT 20035/C in the adjuvant/saline mixture (w/v)
Control group:
- adjuvant/saline mixture 1:1 (v/v)
- adjuvant/saline mixture 1:1 (v/v)
- physiological saline
DAY 8: INDUCTION, epidermal application
The application site of all animals was pretreated with 10 % sodium-laurylsulfate (open application) 24 hours prior to the epidermal induction application.
In the test group FAT 20035/C was incorporated in physiological saline and applied on a filter paper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g per patch; occluded administration for 48 hours).
The control group was treated with the vehicle only.
Test group:
- 50 % FAT 20035/C in physiological saline
Control group:
- physiological saline only
DAY 21: Challenge
The test and control group animals were tested on one flank with FAT 20035/C in physiological saline and on the other flank with the vehicle alone (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 2 4 hours).
Test and control group:
- 30 % FAT 20035/C in physiological saline
- physiological saline only - Challenge controls:
- The test and control group animals were tested on one flank with FAT 20035/C in physiological saline and on the other flank with the vehicle alone (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 2 4 hours).
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole puriss
Results and discussion
- Positive control results:
- None
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- 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:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Erythema in one animal
- 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:
- no indication of skin sensitisation
- 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:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 30 %
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Erythema and edema
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- 2-Mercaptobenzothiazole puriss
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Erythema and edema
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- 2-Mercaptobenzothiazole puriss
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20035/C did not show a skin - sensitising (contact allergenic) potential in albino guinea pigs.
- Executive summary:
A GLP-compliant study was performed to detect the sensitisation potential of FAT 20035/C in the guinea pig maximisation test, by following the OECD Guideline No. 406, adopted May 12, 1981 and on Annex V, Part B of Council Directive 67/548/EEC (Commission Directive 92/69/EEC of July 31, 1992). During induction phase on zero day test substance was delivered by intradermal injections. Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the left and right side of the shaved neck of the test and control group animals. On day 8 of induction epidermal application of the test substance was done. In the test group FAT 20035/C was incorporated in physiological saline and applied on a filter-paper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g per patch; occluded administration for 48 hours). The control group was treated with the vehicle only. And in the Challenge phase the test and control group animals were tested on one flank with FAT 20035/C in physiological saline and on the other flank with the vehicle alone (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 24 hours).
No animal of the test group was sensitised by FAT 20035/C under the experimental condition employed. FAT 20035/C did not show a skin - sensitising (contact allergenic) potential in albino guinea pigs.
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