Registration Dossier
Registration Dossier
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EC number: 276-882-8 | CAS number: 72828-69-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 January 1994 to 3 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:
- yes
- Remarks:
- 20 % propylene glycol was used as a vehicle instead of physiological saline. In this study challenge with the test substance was performed under occlusive testing conditions, representing elevated testing conditions.
- 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:
- Disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]
- EC Number:
- 276-882-8
- EC Name:
- Disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]
- Cas Number:
- 72828-69-4
- Molecular formula:
- C47H42N10O12S4.2Na
- IUPAC Name:
- disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Test article: FAT 21015/B
Batch No.: 1
Additional specification: Polar Gelb 4G roh trocken
Contents/Purity: CA. 80%
Physical properties: solid; yellow-orange powder
Storage conditions: room temperature
Validity: October, 1998
Test article received: November 19, 1993
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 1
- Expiration date of the lot/batch: October, 1998
- Purity: 80 %
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
- Weight at study initiation: 321 to 407 g
- Housing: individually in Macrolon cages (Type 3)
- Diet: standard guinea pig pellets - NAFAG No. 845, Gossau SG ad libitum
- Water: fresh water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 h light cycle
- IN-LIFE DATES: From: January 24, 1994 To: March 24, 1994
The test was performed on a total of 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group, respectively.
The test was started with the minimum number of animals (5 per sex for the test group and 5 of one sex for controls). After the challenge procedure, it was not possible to conclude if the test substance is a sensitiser or not and therefore testing in additional animals was performed to give a total of 20 test and 10 control animals. The initial weight of the animals was between 321 to 407 g.
The animals were housed individually in Macrolon cages (Type 3) , assigned to the different groups by means of random numbers generated by the random number generator, identified by individual ear tags, kept at a constant room temperature of 22+-3°C, at a relative humidity of 30 to 70% and a 12 hours light cycle day.
The animals received ad libitum standard guinea pig pellets - NAFAG No. 845, Gossau SG and fresh water.
All batches of the diet are assayed for nutritive ingredients and contamination level by the manufacturer. Analytical results are available at the animal supply office.
The drinking water quality fulfilled the critical parameters in the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972). The results of the routine chemical examination of water at source (Grundwasserfassung Stein) as conducted periodically by the water authority (Baudepartement des Kantons Aargau, Abteilung Gewaesserschütz) are available to CIBA-GEIGY Limited, as well as the results of inhouse chemical analysis by the analytical laboratories of the Pharmaceutical Division, CIBA-GEIGY Limited.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 5%
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- 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
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 20%
- Day(s)/duration:
- Day 21
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group, respectively.
- Details on study design:
- None
- Challenge controls:
- None
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole
Results and discussion
- Positive control results:
- 100 % positive results (All 20 animals were found positive)
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Intradermal injection - 5 %, Epidermal application - 50 % and Challenge - 20 %
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- Under the experimental conditions employed, 20 % and 10 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Intradermal injection - 5 %, Epidermal application - 50 % and Challenge - 20 %
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- Under the experimental conditions employed, 20 % and 10 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20 % propylene glycol and vaseline
- 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:
- negative control
- Dose level:
- 20 % propylene glycol and vaseline
- 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:
- positive control
- Dose level:
- 5% intradermal induction, 50% epidermal induction and 30% epidermal challenge
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Erythema and edema in all animals
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- 2-Mercaptobenzothiazole puriss
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5% intradermal induction, 50% epidermal induction and 30% epidermal challenge
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Erythema and edema in all animals
- 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 21015/B is not considered as a skin sensitiser in rabbit.
- Executive summary:
A key study was performed to determine the skin sensitization potential of FAT 21015/B according to OECD Guideline No. 406 and on Annex V, Part B of Council Directive 67/548/EEC (Commission Directive 92/69/EEC of July 31, 1992). The test was performed on a total of 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group, respectively. The concentrations for the intradermal and epidermal inductions as well as challenge were selected on the basis of a preliminary study conducted to assess the primary irritation potential of the test article. 5, 50 and 20 % concentrations of FAT 21015/B were chosen for intradermal induction, epidermal induction and challenge, respectively. Main study was carried out as below
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 21015/B in 20 % propylene glycol (w/v)
- 5 % FAT 21015/B in the adjuvant/saline mixture (w/v)
Control group:
- adjuvant/saline mixture 1:1 (v/v)
- adjuvant/saline mixture 1:1 (v/v)
- 20 % propylene glycol
DAY 8: INDUCTION, epidermal application
In the test group FAT 21015/B was incorporated in Vaseline (w/w) 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 21015/B in vaseline
Control group:
- vaseline only
DAY 21: Challenge
The test and control group animals were tested on one flank with FAT 21015/B in vaseline (w/w) 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:
- 20 % FAT 21015/B in vaseline
- vaseline only
Following the challenge, 20 and 10 % of the animals of the test group showed skin reactions 24 and 48 h after removing the dressings, respectively. Hence, based on the CLP (Regulation 1272/2008) criteria, FAT 21015/B is not a skin sensitiser.
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