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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across for skin sensitisation in group with two other substances proposed in EU Risk Assessment Report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes
Type of study:
mouse local lymphnode assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
not specified

Study design: in vivo (LLNA)

Vehicle:
unchanged (no vehicle)
Concentration:
25 µL of test material (undiluted)
No. of animals per dose:
four
Details on study design:
In a preliminary test, 25 μl of undiluted TCPP was applied topically to the dorsal surface of the ears of one CBA/Ca mouse for three consecutive days and observations were made up to day 6. No clinical signs were noted. In the main test, groups of four CBA/Ca mice were treated with 25 μl undiluted TCPP or concentrations of 50% or 25% v/v in acetone: olive oil 4:1 for three days. A further group of four mice received the vehicle alone. Five days following the first topical application, all mice were injected via the tail vein with 250 μl of phosphate buffered saline (PBS) containing a total of 20 μCi 3H-methyl thymidine (specific activity 2.0 Ci/mmol). All mice were terminated five hours after injection.

Results and discussion

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: Stimulation indices of 1.55, 1.97 and 1.56 were recorded for concentrations of 25, 50 and 100% v/v, respectively.

Any other information on results incl. tables

There were no mortalities or clinical observations and all bodyweights were comparable to those of the control animals.

Applicant's summary and conclusion