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Toxicological information

Skin sensitisation

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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:
1990

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

Constituent 1
Chemical structure
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%

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.