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EC number: 204-800-2 | CAS number: 126-73-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable and well documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- Principles of method if other than guideline:
- Tributyl phosphate (0.3 ml of a 10% mixture in mineral oil) was applied topically to the left shoulders (previously clipped free of hair) of 10 male and 10 female Hartley guinea pigs (test group). The test material mixture was left in contact with the skin for approximately 6 hours. The animals received 3 induction treatments one week apart. A concurrent positive control group of 10 animals (5 male and 5 female) was treated in a similar manner with DNCB (Dinitrochlorobenzene) (0.15%). An additional 10 animals (5 male and 5 female) were treated in a similar manner with mineral oil as a vehicle control group.
14 days after the third induction treatment, the animals were challenged with the test material mixture at a virgin skin site on the right shoulder. An additional 5 male and 5 female naive animals received 0.3 ml of the test material mixture (challenge control group). The positive control group was challenged with DNCB. The vehicle control group was challenged with mineral oil. Observations for skin reactions were recorded at 24 and 48 hours after each application. body weights were recorded at initiation and termination. - GLP compliance:
- yes
- Type of study:
- open epicutaneous test
Test material
- Reference substance name:
- Tributyl phosphate
- EC Number:
- 204-800-2
- EC Name:
- Tributyl phosphate
- Cas Number:
- 126-73-8
- Molecular formula:
- C12H27O4P
- IUPAC Name:
- tributyl phosphate
- Details on test material:
- purity: 99.7%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- 10%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- 10%
- No. of animals per dose:
- 10 male and 10 female guinea pigs
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.3 ml of a 10% solution
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.3 ml of a 10% solution. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.3 ml of a 10% solution
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.3 ml of a 10% solution. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
Tributyl phosphate (0.3 ml of a 10% mixture in mineral oil) was applied topically to the left shoulders (previously clipped free of hair) of 10 male and 10 female Hartley guinea pigs (test group). The test material mixture was left in contact with the skin for approximately 6 hours. The animals received 3 induction treatments one week apart. A concurrent positive control group of 10 animals (5 male and 5 female) was treated in a similar manner with DNCB (Dinitrochlorobenzene) (0.15%). An additional 10 animals (5 male and 5 female) were treated in a similar manner with mineral oil as a vehicle control group.
14 days after the third induction treatment, the animals were challenged with the test material mixture at a virgin skin site on the right shoulder. An additional 5 male and 5 female naive animals received 0.3 ml of the test material mixture (challenge control group). The positive control group was challenged with DNCB. The vehicle control group was challenged with mineral oil. Observations for skin reactions were recorded at 24 and 48 hours after each application. body weights were recorded at initiation and termination.
No irritation was noted on any animal in the test, challenge control or vehicle control groups during the study. animals in the positive control group showed no skin reactions after the first induction application. Mild to moderate erythema was noted after the second induction and mild to severe erythema, edema and eschar were noted after the third induction application. At challenge, all positive control animals exhibited severe reactions.
Under the conditions of this study, the test material is judged to be non-sensitizing when topically applied to Hartley guinea pigs.
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