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Diss Factsheets

Administrative data

Description of key information

Testing for sensitising properties of phosphinic acid, diethyl aluminium salt (source substance)

was performed in female guinea pigs according to OECD 406. Intradermal induction was performed using 5 %, the dermal induction using 25% in sesame oil. The challenge was carried out with 25% test substance (epidermal) sesame oil.

Phosphinic acid, diethyl aluminium salt (source substance) did not induce allergic reactions and therefore, phosphinic acid, diethyl sodium salt (target substance) is not considered to be a skin sensitiser.

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:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
already existing in vivo data
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
according to guideline
Route:
intradermal
Vehicle:
other: sesame oil (DAB 10)
Concentration / amount:
intradermal: 5% in seame oil; dermal: 25% in sesame oil
Day(s)/duration:
2
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil (DAB 10)
Concentration / amount:
dermal: 25% in seame oil
Day(s)/duration:
1
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
test group: 10
controll group 5
Details on study design:
according to guideline
Challenge controls:
according to guideline
Positive control substance(s):
yes
Remarks:
The validity of the test system is confirmed by the periodically conducted positive control test using benzocain for the maximization test (report no. 97.0326, dated June 02, 1997).
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signes
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signs
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no signs
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no signs
Interpretation of results:
GHS criteria not met
Remarks:
no sensitising
Conclusions:
In a guinea pig sensitization study according to OECD 406 caused no allergic reaction in all animals. The number of affected guinea pigs was not high enough to be significant. Methylparaben is not considered to be a skin sensitiser. Therefore, the test substance has not to be classified as skin sensitiser.
Executive summary:

Testing for sensitising properties of phosphinic acid, diethyl aluminium salt (source substance)

was performed in female guinea pigs according to OECD 406. Intradermal induction was performed using 5 %, the dermal induction using 25% in sesame oil. The challenge was carried out with 25% test substance (epidermal) sesame oil.

Phosphinic acid, diethyl aluminium salt (source substance) did not induce allergic reactions and therefore, phosphinic acid, diethyl sodium salt (target substance) is not considered to be a skin sensitiser.

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

Testing for sensitising properties of phosphinic acid, diethyl aluminium salt (source substance)

was performed in female guinea pigs according to OECD 406. Intradermal induction was performed using 5 %, the dermal induction using 25% in sesame oil. The challenge was carried out with 25% test substance (epidermal) sesame oil.

Phosphinic acid, diethyl aluminium salt (source substance) did not induce allergic reactions and therefore, phosphinic acid, diethyl sodium salt (target substance) is not considered to be a skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There are no respiratory sensitization properties of the substance known in literature. Beyond this there is no hint of any sensitization property of the compound (source substance) from the conducted skin sensitization study. Therefore, it is concluded that the substance is not a respiratory sensitizer.

Justification for classification or non-classification

The source substance (phosphinic acid, diethyl, aluminium salt has been tested to the Guinea pig maximization test according to OECD 406 to assess the sensitising potential of the test item. The study did not result in a allergical response.

A classification concerning skin and respiratory sensitizing properties is not warranted for the target substance phosphinic acid, diethyl, sodium salt as the classification criteria according to EU regulation 1272/2008 are not met.