Registration Dossier
Registration Dossier
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Reaction mass of Cobaltate(3-), bis[2-[[[3-[2-[1-[[(2-chlorophenyl)amino]carbonyl]-2-(oxo-κO)propyl]diazenyl-κN1]-4-(hydroxy-κO)phenyl]sulfonyl]amino]benzoato(3-)]-, sodium (1:3) and tetrasodium bis[2-[[[3-[[1-[(2-chloroanilino)carbonyl]-2-oxopropyl]azo]-4-hydroxyphenyl]sulphonyl]amino]benzoato(3-)]cobaltate(4-)
EC number: 941-792-6 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 10 May, 1993 to 10 June, 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Principles of method if other than guideline:
- not applicable
- 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.
Test material
- Reference substance name:
- Reaction mass of Trisodium bis[2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN1)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)]cobaltate(3-) and Trisodium [2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN1)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)][2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN2)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)]cobaltate(3-)
- EC Number:
- 941-792-6
- Cas Number:
- not given
- Molecular formula:
- C46H32Cl2CoN8O14S2.3Na
- IUPAC Name:
- Reaction mass of Trisodium bis[2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN1)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)]cobaltate(3-) and Trisodium [2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN1)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)][2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN2)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)]cobaltate(3-)
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Test article: FAT 92368/A
Batch No.: PLN 13
Additional specification: Lanacron Gelb S-2G roh Lösung laboreingedampft
Contents/Purity: ca.80 %
Physical properties: solid; orange powder
Storage conditions: room temperature
Validity: March 1998
Test article received: April 6, 1993
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif: DHP)
- 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: 332 to 416 g
- Housing: The animals were housed individually in Macrolon cages (Type 3)
- Diet (e.g., ad libitum): Standard guinea pig pellets - NAFAG No. 845, Gossau SG, ad libitum
- Water: Fresh water, ad libitum
- Acclimation period: At least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30-70 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: To: 10 May 1993 to 10 June 1993
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: FCA/physiological saline
- Concentration / amount:
- 5 %
- Day(s)/duration:
- Week 1
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 50 %
- Day(s)/duration:
- week 2
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 20 %
- Day(s)/duration:
- Week 5
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Control group: 10 animals (5 male and 5 female)
Test group: 20 treated animals (10 male and 10 female) - Details on study design:
- Induction procedure (weeks 1 and 2):
The induction was a two-stage operation. First, intradermal injections (into the neck region); second, closed patch exposure over the injection sites one week later.
First induction week, intradermal injection:
Three pairs of intradermal injections (0.1 mL/injection) were made simultaneously into the shaved neck of the guinea pigs as follows:
- adjuvant/saline mixture 1:1 (v/v)
- test substance in physiological saline (w/v)
- test substance in the adjuvant/saline mixture (w/v)
Second induction week, epidermal application:
In the second week of induction test substance was incorporated in vaseline (w/w) and applied on a filter paper patch to the neck of the animals (patch 2x4 cm approx. 0.4 g paste per patch: occluded administration for 48 h).
Rest period:
During weeks 3 and 4 no treatments were performed.
Challenge (week 5):
The animals were tested on the flank with test substance in Vaseline (w/w) and the vehicle alone (patch 2x2 cm; approx. 0.2 g paste per patch; occluded administration for 24 h).
Control group:
A control group of 10 animals (5 males/5 females) was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test substance to check the maximum subirritant concentration of the test substance in adjuvant treated animals. - Challenge controls:
- no data
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole puriss. tested in another study
Results and discussion
- Positive control results:
- Positive response was observed in 90% of the treated animals after the occlusive epidermal challenge application.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- Very slight erythema
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- Very slight erythema
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Vehicle control and test article
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Vehicle control and test article
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Intradermal induction: 0.2 %, epidermal induction: 5 % and epidermal challenge: 1 %
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Intradermal induction: 0.2 %, epidermal induction: 5 % and epidermal challenge: 1 %
- No. with + reactions:
- 9
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The test substance was concluded to have induced delayed contact hypersensitivity in treated animals.
- Executive summary:
A guinea pig maximization study was conducted to evaluate the skin sensitization potential of the test substance (of ca. 80 % purity) according to OECD Guideline 406 and EU Method B.6 in compliance with GLP.
Based on the results of a preliminary study, 5 and 50 % concentrations were selected as intradermal and topical induction doses. The highest non-irritating concentration used for challenge application was 20 %. After the challenge application, 20 % and 45 % of the animals of the test group showed skin reactions 24 and 48 h after removing the dressings, respectively. Hence, the test substance was concluded to have induced delayed contact hypersensitivity in treated animals.
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