Registration Dossier
Registration Dossier
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EC number: 216-676-7 | CAS number: 1638-86-4
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-09-17 to 1997-10-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and 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)
- Version / remarks:
- 1992-07-17
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Diethyl phenylphosphonite
- EC Number:
- 216-676-7
- EC Name:
- Diethyl phenylphosphonite
- Cas Number:
- 1638-86-4
- Molecular formula:
- C10H15O2P
- IUPAC Name:
- diethyl phenylphosphonite
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Diethoxyphenlyphosphin- DEOPP
- Physical state: liquid, colourless
- Analytical purity: 98.4 g/100g (GC)
- Lot/batch No.: 96-1008-9-HL
- Date of manufacturing: 1996-07-11
- Storage condition of test material: room temperature, exclusion of moisture, light and oxygen (store under nitrogen)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River GmbH -Wiga, Kisslegg, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 330-392 g
- Housing: 5 animals per cage, cage-type: Makrolon type IV
- Diet: Kliba Labordiät ad libitum
- Water: tap water ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):21-25
- Humidity (%):30-70
- Photoperiod (hrs dark / hrs light):12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 1st, 2nd and 3rd induction: test substance 25% in olive oil
Challenge and re-challenge: test substance 10 % in olive oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 1st, 2nd and 3rd induction: test substance 25% in olive oil
Challenge and re-challenge: test substance 10 % in olive oil
- No. of animals per dose:
- 10 (controls); 20 (test group)
- Details on study design:
- RANGE FINDING TESTS:
3 animals per test concentration, 6 hours exposure, application frequency 2 times o the same area (one apllication per week)
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Site:anterior left flank
- Frequency of applications:one application per week; days 0,7 and 14
B. CHALLENGE EXPOSURE
- No. of exposures:2
- Day(s) of challenge:a challenge was carried out 14 days after the third induction, a rechallenge one week after the challenge
- Exposure period: 6 hours
- Site: Challenge: test substance formulation: anterior right flank, vehicle: posterior right flank;
Rechallenge: test substance formulation: anterior left flank, vehicle: posterior left flank
- Concentrations: 10 % in olive oil
- Evaluation:24 and 48 h after challenge - Positive control substance(s):
- yes
- Remarks:
- Alpha-Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- Based an the results of the study under the test conditions chosen Alpha-Hexylcinnamaldehyde techn. 85% has a sensitizing effect an the skin af the guinea pig strain usecl (Pirbright White Dunkin Hartley Cr1: (hA) BR [SPF]; Charles River GmbH-Wiga, Kisslegg, Germany, in the BUEHLER Test.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: 1st challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Clinical observations:
- discrete or patchy erythema, moderate + confluent erythema, in some animals with swelling + intense erythema + swelling.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 1st challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 13.0. Total no. in groups: 20.0. Clinical observations: discrete or patchy erythema, moderate + confluent erythema, in some animals with swelling + intense erythema + swelling. .
- Reading:
- other: 1st challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Clinical observations:
- discrete or patchy erythema, moderate and confluent erythema, in some animals with swelling.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 1st challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: discrete or patchy erythema, moderate and confluent erythema, in some animals with swelling..
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- discrete or patchy erythema and moderate and confluent erythema
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: discrete or patchy erythema and moderate and confluent erythema .
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Clinical observations:
- discrete or patchy erythema and moderate and confluent erythema
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: discrete or patchy erythema and moderate and confluent erythema.
- Reading:
- other: 1st challenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 1 animal reacted to the vehicle alone
- Remarks on result:
- other: Reading: other: 1st challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 1 animal reacted to the vehicle alone.
- Reading:
- other: 1st challenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 2 animals reacted to the vehicle alone
- Remarks on result:
- other: Reading: other: 1st challenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 2 animals reacted to the vehicle alone.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- No reactions to the vehicle alone were observed.
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: No reactions to the vehicle alone were observed..
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- No reactions to the vehicle alone were observed.
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: No reactions to the vehicle alone were observed..
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
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