Registration Dossier
Registration Dossier
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EC number: 609-080-7 | CAS number: 35160-38-4
Skin sensitisation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- 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
Test material
- Details on test material:
- None
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- according to guideline
Study design: in vivo (non-LLNA)
Induction
- 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
Challenge
- 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).
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- 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
Applicant's summary and conclusion
- 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.
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