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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

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 lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Test material was LE164, triisodecyl phosphite, >99% purity.

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
The animals were acclimatised for a period of at least 5 days, after which animals were selected at random and given a unique number marked on their tail. At the start of the study the animals weighed in the range of 15 to 23 grams and were 8-12 weeks in age.

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
25%, 50%, 100%
No. of animals per dose:
4
Details on study design:
Five days following the first topical applications, all mice were injected via the tail vein with 250 uL of phosphate buffered saline (PBS) containing 3H-methyl thymidine (3HTdR) giving a total of 20 uCi to each mouse.
Statistics:
EC3= 20%; based on a regression analysis of the dose groups. All dose groups were positive, but there was sufficient dose-response to determine an EC3.

Results and discussion

In vivo (LLNA)

Results
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: vehicle 14023.98 25% 53667.32 50% 103195.40 100% 137149.20

Any other information on results incl. tables

Concentration

dpm/node

Test / Control Ratio

Vehicle (acetone/olive oil 4:1)

1753.00

N/A

25%

6708.42

3.83

50%

12899.43

7.36

100%

17143.65

9.78

EC3= 20%

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Test substance was postive (ratio >3) at concentrations of 25, 50, and 100%. An EC3 was determined to be 20%. The results indicated that TDP is a skin sensitiser, but not a strong skin sensitiser.
Executive summary:

TDP was test using the LLNA assay at concentrations of 25%, 50%, and 100%. It was positive at all test concentrations. The calculated EC3 value is 20.1%. The results suggest that TDP should be classified as a skin sensitiser, but not a strong skin sensitiser.