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Registration Dossier
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EC number: 203-509-8 | CAS number: 107-66-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 1999 to May 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Principles of method if other than guideline:
- Testing for sensitizing properties of dibutyl hydrogen phosphate was performed in female guinea pigs according to the method of Magnusson & Kligman.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted in 1999. At this time an OECD guideline for a LLNA was not available.
Test material
- Reference substance name:
- Dibutyl hydrogen phosphate
- EC Number:
- 203-509-8
- EC Name:
- Dibutyl hydrogen phosphate
- Cas Number:
- 107-66-4
- Molecular formula:
- C8H19O4P
- IUPAC Name:
- dibutyl hydrogen phosphate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: HsdPoc:HD
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Weight at study initiation: 358 to 492 g
- Housing: in groups of 5
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3°C
- Humidity (%): 50 +- 20%
- Photoperiod (12 hrs dark / 12 hrs light):
- IN-LIFE DATES: From: March 1999 To: May 1999
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 1% in deionized water
- Day(s)/duration:
- single injection followed by dermal induction 7 days later
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 10% in deionized water
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 2% in deionized water
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Test group Number of animals
Determination 01 the primary non-irritant concentration 3
Determination 01 the tolerance 01 the intradermal injections 2
Control group 5
Treatment group 10 - Details on study design:
- 1st application: Induction 1 % intracutaneous
2nd application: Induction 10 % occlusive epicutaneous
3rd application: Challenge 2 % occlusive epicutaneous - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexyl cinnamic aldehyde, 25% in polyethylene glycol 400
Results and discussion
- Positive control results:
- The results of the positive control experiment resulted in 80% sensitization (8/10 animals).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25% alpha-hexyl cinnamic aldehyde
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 2 % dibutyl hydrogen phosphate
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2 % dibutyl hydrogen phosphate
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2 % dibutyl hydrogen phosphate
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2 % dibutyl hydrogen phosphate
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25% alpha-hexyl cinnamic aldehyde
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
The body weight gains of all animals treated with the test item were not impaired.
The treated animals showed no clinical signs of intoxication throughout the study.
lntradermal induction treatment:
The intradermal injections with Freund's Adjuvant (with and without test substance) caused clear up to severe erythema and edema as weil as indurations and encrustations and necrosis. The intradermal injections with the test substance in deionized water showed clear erythema and edema as weil as indurations and
encrustations and necrosis. lntradermal injections of the vehicle alone exhibited no
signs of irritation. Due to these strong irritation reactions of the skin, 10% sodium dodecylsulfate was not administered at day 7.
Dermal induction treatment:
After the removal of the patches at day 10, clear up to severe erythema and edema, indurated, encrusted skin as weil as necrosis were observed at the sites previously treated with Freund's Adjuvant (with and without test substance). The administration sites treated with the vehicle alone showed no signs of irritation.
Dermal challenge treatment
No skin reactions were observed in the control and the treatment group 24 and 48
hours after removal of the occlusive bandage.
Under the conditions of the present study, none of ten animals of the treatment group showed a positive skin response after the challenge procedure.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Testing for sensitizing properties of dibutyl hydrogen phosphate was performed in female guinea pigs according to the method of Magnusson & Kligman.
Intradermal induction was performed using 1.0 % dibutyl hydrogen phosphate in deionized water. Dermal induction was carried out with 10.0 % dibutyl hydrogen phosphate in deionized water. Challenge treatment was carried out with 2.0 % dibutyl hydrogen phosphate in deionized water.
The validity of the test system is confirmed by the periodically conducted positive control test using alpha-hexyl cinnamic for the maximization test.
Under the conditions of the present study, none of ten animals of the treatment group showed a positive skin response after the challenge procedure.
Based on the results of this study dibutyl hydrogen phosphate showed no evidence for sensitizing properties.
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