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EC number: 266-577-8 | CAS number: 67109-27-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 May 1994 to 14 July 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Swiss GLP
- 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.
Test material
- Reference substance name:
- Sodium bis[2-chloro-4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-hydroxybenzenesulphonamidato(2-)]chromate(1-)
- EC Number:
- 266-577-8
- EC Name:
- Sodium bis[2-chloro-4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-hydroxybenzenesulphonamidato(2-)]chromate(1-)
- Cas Number:
- 67109-27-7
- Molecular formula:
- C32H24Cl2CrN10O8S2.Na
- IUPAC Name:
- sodium bis[2-chloro-4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-hydroxybenzenesulphonamidato(2-)]chromate(1-)
- Test material form:
- not specified
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: 11
- Expiration date of the lot/batch: December, 1998
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
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
- Females (if applicable) nulliparous and non-pregnant: not specified]
- Age at study initiation:
- Weight at study initiation: 325 to 407 g
- Housing: individually in Macrolon cages (Type 3)
- Diet: standard guinea pig pellets -NAFAG No. 845, Gossau SG ad libitum
- Water: ad libitum
- Acclimation period: 5 d
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 h light cycle
- IN-LIFE DATES: From: May 2, 1994 To: July 14, 1994
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 % / 0.4g
- Day(s)/duration:
- Day 8
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 1 % / 0.2 g
- Day(s)/duration:
- Day 21/22
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- - Challenge procedure: 5 per sex for the test group and 5 of one sex for controls.
- Additional animals was performed to give a total of 20 test and 10 control animals. - Details on study design:
- Test procedure and concentrations used.
Pretests
*Intradermal Induction:
The concentration for the intradermal injections was selected on account of the solubility of the test article in standard vehicles and its local and systemic tolerability in a pretest. The following concentration of test article has been used for intradermal injection:
5 % in physiological saline (w/v).
Since 5 % FAT 20028/D in physiological saline could be injected and was well tolerated, this concentration was used for the intradermal induction.
*Epidermal Applications (induction and challenge):
The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations of FAT 20028/D have been examined on separate animals for the determination of the maximum subirritant concentration
- 1, 5, 10, 20, 30, and 50 % in physiological saline.
- 50 % was the highest possible concentration of the test article in physiological saline.
- Reactions were observed with 5, 10, 20, 30, and 50 % FAT 20028/D in physiological saline.
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 20028/D in physiological saline (w/v)
- 5 % FAT 20028/D 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:
In the test group FAT 20028/D 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 20028/D in physiological saline
Control group:
- physiological saline only
DAY 21/22: Challenge:
The test and control group animals were tested on one flank with FAT 20028/D 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).
Test and control group:
- 1 % FAT 20028/D in physiological saline
- physiological saline only - Positive control substance(s):
- no
- Remarks:
- However, 2-Mercaptobenzothiazole used to check he sensitivity of the strain once or twice a year
Results and discussion
- Positive control results:
- The sensitivity of the strain is checked once or twice a year with a known mild to moderate sensitiser, such as mercaptobenzothiazole, hexyl cinnamic aldehyde or potassiumdichromate.
*Results with 2-Mercaptobenzothiazole puriss.:
Experimental starting date: January 3, 1994
Experimental completion date: January 27, 1994
The following concentrations of the reference compound and vehicles were used:
- Intradermal induction:
Concentration of compound: 5 %
Vehicle: Oleum arachidis
- Epidermal induction:
Concentration of compound: 50 %
Vehicle: vaseline
- Epidermal challenge:
Concentration of compound: 30 %
Vehicle: vaseline
Results:
Control group:
Vehicle control after 24 h: 0/10; test article after 24 h: 0/10
Vehicle control after 48 h: 0/10; test article after 48 h: 0/10
Test group:
Vehicle control after 24 h: 0/20; test article after 24 h: 20/20
Vehicle control after 48 h: 0/20; test article after 48 h: 20/20
Test and results fullfil the requirements for reliability check of the OECD Guideline 406.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% (0.2 g per patch)
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- Erythema score: 1
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% (0.2 g per patch)
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- Erythema score: 1s and Edema score: 1
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 30% of 2-Mercaptobenzothiazole in vaseline
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Erythema and edema
- Remarks on result:
- other: Reference values of positive control (2-Mercaptobenzothiazole) from the study carried out in 1994 to check the sensitivity of strain.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 30% of 2-Mercaptobenzothiazole in vaseline
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Erythema and edema
- Remarks on result:
- other: Reference values of positive control (2-Mercaptobenzothiazole) from the study carried out in 1994 to check the sensitivity of strain.
Any other information on results incl. tables
There were no effects on body weights because of the treatment. Scaling was observed in one male 48 h after removing the dressings. Under the experimental conditions employed, 5 % of the animals of the test group showed skin reactions 24 and 48 h after removing the dressings.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20028/D showed a weak grade of skin-sensitising (contact allergenic) potential in albino guinea pigs, however not considered as skin sensitiser as per CLP classification.
- Executive summary:
This sensitisation test in albino guinea pigs was performed to determine the contact allergenic potency of FAT 20028/D in albino guinea pigs. This test was based on the OECD Guideline No. 406, adopted May 12, 1981, adapted July 17, 1992, by the OECD council, and on Annex V, Part B of council Directive 67/548/EEC (Commission Directive 92/69/EEC of July 31, 1992. This study has been performed in compliance with Good Laboratory Practice (GLP) in Switzerland.
Test procedure and concentrations used.
Pretests
*Intradermal Induction:
The concentration for the intradermal injections was selected on account of the solubility of the test article in standard vehicles and its local and systemic tolerability in a pretest. The following concentration of test article has been used for intradermal injection:
5 % in physiological saline (w/v).
Since 5 % FAT 20028/D in physiological saline could be injected and was well tolerated, this concentration was used for the intradermal induction.
*Epidermal Applications (induction and challenge)
The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations of FAT 20028/D have been examined on separate animals for the determination of the maximum subirritant concentration
- 1, 5, 10, 20, 30, and 50 % in physiological saline.
- 50 % was the highest possible concentration of the test article in physiological saline.
- Reactions were observed with 5, 10, 20, 30, and 50 % FAT 20028/D in physiological saline.
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 andcontrol group animals.
Test group:
- adjuvant/saline mixture 1:1 (v/v)
- 5 % FAT 20028/D in physiological saline (w/v)
- 5 % FAT 20028/D 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
In the test group FAT 20028/D was incorporated in physiological saline and applied on a filterpaper 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 20028/D in physiological saline
Control group:
- physiological saline only
DAY 21/22: Challenge
The test and control group animals were tested on one flank with FAT 20028/D 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 h).
Test and control group:
- 1 % FAT 20028/D in physiological saline
- physiological saline only
Conclusion:
Under the experimental conditions employed, 5 % of the animals of the test group showed skin reactions 24 and 48 h after removing the dressings.
According to the maximisation grading of Magnusson and Kligman FAT 20028/D showed a weak grade of skin-sensitising (contact allergenic) potential in albino guibea pigs, however not considered as skin sensitiser as per CLP classification.
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