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Diss Factsheets

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:
1990

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

Constituent 1
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

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.