Registration Dossier
Registration Dossier
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EC number: 616-639-9 | CAS number: 78620-07-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: conducted to OECD/EC guidelines with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Details on test material:
- - Name of test material (as cited in study report): Belcor 575 trisodium salt (TK13061/2)
- Physical state: Aqueous solution
- Aqueous sodium salt solution formed by neutralising acid with sodium hydroxide (52% Belcor 575, 48% NaOH)
- Lot/batch No.: PAD-A-240-226-D
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Ltd, Tierfarm
- Age at study initiation: approximately 10 weeks old.
- Weight at study initiation: 363 - 455 grams
- Housing: Macrolon cages, type 3
- Diet (e.g. ad libitum): ad libitum guinea pig pellets (NAFAG No. 845, Gossau SG)
- Water (e.g. ad libitum): ad libitum fresh water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- First induction week, intradermal application : 0.1 ml of one of three preparations (adjuvant/saline mixture 1:1 (v/v); test article TK13061/2 in physiological saline (w/v); test article TK13061/2 in the adjuvant saline mixture (w/v). - [test material concentration 5%].
Second inductionweek, epidermal aplication: 0.4g paste of TK13061/2 incorporated in vaseline (w/w) [Test material concentration 10%].
Challenge: 0.2g paste of TK13061/2 incorporated in vaseline (w/w) [test material concentration 3%].
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- petrolatum
- Concentration / amount:
- First induction week, intradermal application : 0.1 ml of one of three preparations (adjuvant/saline mixture 1:1 (v/v); test article TK13061/2 in physiological saline (w/v); test article TK13061/2 in the adjuvant saline mixture (w/v). - [test material concentration 5%].
Second inductionweek, epidermal aplication: 0.4g paste of TK13061/2 incorporated in vaseline (w/w) [Test material concentration 10%].
Challenge: 0.2g paste of TK13061/2 incorporated in vaseline (w/w) [test material concentration 3%].
- No. of animals per dose:
- 20 animals (male/female) in test group and 20 animals (male/female) in control group.
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: Intradermal injection followed by a closed patch exposure over injection site one week later.
- Test groups: 0.1 ml of one of three preparations (adjuvant/saline mixture 1:1 (v/v); test article TK13061/2 in physiological saline (w/v); test article TK13061/2 in the adjuvant saline mixture (w/v). - [test material concentration 5%]. Second induction: 0.4g paste of TK13061/2 incorporated in vaseline (w/w) [Test material concentration 10%].
- Control group: treated with adjuvant and vehicle only.
- Site: neck region
- Duration: 1x injection and 1x patch
- Concentrations: 5% test material for injection; 10% test material for epidermal application.
B. CHALLENGE EXPOSURE
- Exposure period: 24 hours
- Test groups: 0.2g of TK13061/2 in vaseline (w/w)
- Control group: treated with the vehicle as well as the test article (at least 10 animals) to check the maximum subirritant concentration of the test article in adjuvant treated animals.
- Site: Flank
- Concentrations: 0.2g of TK13061/2 in vaseline (w/w) (concentration of test material 3%).
Results and discussion
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:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 10.0. Total no. in groups: 20.0.
- 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:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 10.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- 50% of the animals were sensitized by TK13061/2. According to the maximization grading, TK13061/2 showed a moderate grade of skin sensitizing (contact allergenic) potential in albino guinea pigs.
- Executive summary:
In a dermal sensitization study twenty 10 week old male and female pirbright white guinea pigs with Trisodium [carboxy(oxido)methyl]phosphonate in petrolatum, were tested using the method of guinea pig maximisation test.
In this study, trisodium [carboxy(oxido)methyl]phosphonate is a moderate dermal sensitizer.
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