Registration Dossier
Registration Dossier
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EC number: 280-068-8 | CAS number: 82933-90-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 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
- Principles of method if other than guideline:
- None
- 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:
- Sodium [5-chloro-3-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphophenyl)-1H-pyrazol-4-yl]azo]-2-hydroxybenzenesulphonato(4-)]chromate(1-)
- EC Number:
- 280-068-8
- EC Name:
- Sodium [5-chloro-3-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphophenyl)-1H-pyrazol-4-yl]azo]-2-hydroxybenzenesulphonato(4-)]chromate(1-)
- Cas Number:
- 82933-90-2
- Molecular formula:
- C16H9ClCrN4O8S2.Na
- IUPAC Name:
- sodium [5-chloro-3-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphophenyl)-1H-pyrazol-4-yl]azo]-2-hydroxybenzenesulphonato(4-)]chromate(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:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 223
- 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:
- 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: 338 to 421 g
- Housing: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,
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5%
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 50%
- 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:
- 50%
- Day(s)/duration:
- Day 21
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 5 per sex for the test and control group.
- Details on study design:
- RANGE FINDING TESTS:
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 20043/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 20043/D have been examined on separate animals for the determination of the maximum sub irritant concentration :
30 and 50 % in physiological saline.
50 % was the highest possible concentration of the test article in physiological saline. The tested concentrations did not induce erythema reactions.
MAIN STUDY
A. INDUCTION EXPOSURE
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 20043/D in physiological saline (w/v)
- 5 % FAT 20043/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
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 20043/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 20043/D in physiological saline
Control group:
- physiological saline only
B. CHALLENGE EXPOSURE
The test and control group animals were tested on one flank with FAT 20043/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:
- 50 % FAT 20043/D in physiological saline
- physiological saline only - Challenge controls:
- - physiological saline only
- Positive control substance(s):
- not specified
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:
- 5%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. Hours after challenge: 24.0. Group: test group. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0 Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Number of positive animals per group after occlusive epidermal application:
| Control Group | After 24 hours | After 48 hours | |||
| Vehicle control | 0/10 | 0/10 | |||
| Test control | 0/10 | 0/10 | |||
| Test Group | After 24 hours | After 48 hours | |||
| Vehicle control | 0/10 | 0/10 | |||
| Test control | 1/10 | 0/10 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20043/D did not show a skin - sensitising (contact allergenic) potential in albino guinea pigs.
- Executive summary:
A study was performed to determine the skin sensitisation potential of FAT 20043/D in rabbits according to OECD Guideline 406 (Skin Sensitisation). Under the experimental conditions employed, 5 % of the animals of the test group showed skin reactions 24 hours after removing the dressings. FAT 20043/D is, therefore, classified as a weak sensitiser in albino guinea pigs according to the grading of Magnusson and Kligman. According to the EEC classification criteria (Commission Directive 93/21/EEC, April 27, 1993) FAT 20043/D did not show a skin - sensitising (contact allergenic) potential in albino guinea pigs.
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