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Diss Factsheets

Administrative data

Description of key information

Sensitization tests on guinea pig (No guideline was followed but a test according to an acceptable standardised method was performed): No evidence of sensitisation was seen in treated animals after the challenge.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: To test for the sensitization potential, a series of exposures was given over a three-week interval.
- Short description of test conditions: Five guinea pigs received nine application of one drop 25 % suspension to clipped abraded back skin, and the other five animals received four sacral intradermal injections of 0.1 ml 1 % solution (w/v). Following a two-week rest period, the animals were challenged for sensitization by applying one drop 25 % concentration of test material.
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The LLNA method was not available yet by the time the study was conducted (1970).
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Phosphonium, Benzyltriphenyl-, chloride (active ingredient 100 %) Lot No. 1887-115 K


Species:
guinea pig
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
No data
Route:
intradermal and epicutaneous
Vehicle:
other: 30 % guinea pig fat in a 1:1 solution of acetone and dioxane
Concentration / amount:
Epicutaneous applications: 25 % (5 animals of the test group received nine applications of one drop on clipped abraded back skin)
Intradermal injections: 0.1 ml 1 % solution (w/v) (test material dissolved to 5 % in a 1:1 solution of acetone and dioxane and then diluted to 1 % in dimethyl phthalate. 5 animals of the test group received 4 sacral intradermal injections, one week apart.
Day(s)/duration:
3 weeks
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, open
Vehicle:
other: thirteen percent guinea pig fat in a 1:1 solution of acetone and dioxane
Concentration / amount:
25 % w/v concentration of test material
Day(s)/duration:
not specified/ 1 day
Adequacy of challenge:
not specified
No. of animals per dose:
10 animals per dose
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- Five guinea pigs received nine applications of one drop 25 % suspension in 30 % guinea pig fat in a 1:1 solution of acetone and dioxane to clipped abraded back skin, and the other five animals received four sacral intradermal injections (one week apart) of 0.1 ml 1 % solution (w/v) (Test material dissolved to 5% in a 1:1 solution of acetone and dioxane and then diluted to 1 % in dimethyl phthalate).

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Challenge occurred after two-week rest period
- Exposure period: To test for sensitization potential, a series of exposures was given over a three-week interval.
- Test groups: 10 animals (one drop of solution was applied on intact skin or abraded skin)
- Control group: a set of 10 previously unexposed guinea pigs was similarly treated at this time to serve as controls for the challenge reactions.
- Site: shoulder skin.
- Concentrations: 25 % concentration of test material in 30% guinea pig fat in a 1:1 solution of acetone and dioxane
- Evaluation: 24 hr after challenge

Challenge controls:
A set of 10 previously unexposed guinea pigs was similarly treated at this time to serve as controls for the challenge reactions.
Positive control substance(s):
no
Positive control results:
No positive control was used.
Key result
Reading:
1st reading
Group:
test chemical
Dose level:
1 % solution in 4 intradermal injections, then challenge 25% w/v
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No data
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Group:
test chemical
Dose level:
25% w/v suspension in 9 applications, then challenge with 25% w/v
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no data
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Group:
negative control
Dose level:
unexposed during 1st phase, then challenge with 25% w/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No data
Remarks on result:
no indication of skin sensitisation
Reading:
other: not applicable
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
GHS criteria not met
Conclusions:
Benzyltriphenylphosphonium chloride is not a skin sensitizer when tested on guinea pig.
Executive summary:

The objective of this study was to determine the potential of Benzyltriphenylphosphonium chloride to induce sensitization effect in guinea pigs. No guideline was followed but a test according to an acceptable standardised method has been performed. In order to test for the sensitization potential a series of standardised exposures was given over a three-week interval. Five guinea pigs received nine applications of one drop 25 % suspension in 30 % guinea pig fat in a 1:1 solution of acetone and dioxane (f.a.d.) to clipped abraded back skin, and the other five animals received four sacral intradermal injections (one week apart) of 0.1 ml 1% solution (w/v). Following a two-week rest period, the animals were challenged for sensitization by applying one drop 25 % concentration of test material in f.a.d. to both shaved intact and clipped abraded skin. A set of ten previously unexposed guinea pigs was similarly treated at this time to serve as controls for the challenge reactions. No evidence of sensitisation was seen in treated animals after the challenge exposure. Benzyltriphenylphosphonium chloride is not a skin sensitizer when tested on guinea pig skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

According to GHS criteria, no skin sensitisation is required for the Benzyltriphenylphosphonium Chloride.