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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of triphenyl phosphite and isodecanol (1:2)
EC Number:
701-374-4
Cas Number:
25550-98-5
Molecular formula:
C26H47O3P
IUPAC Name:
Reaction products of triphenyl phosphite and isodecanol (1:2)

In vivo test system

Test animals

Species:
mouse
Strain:
other: CBA/Ca
Sex:
female
Details on test animals and environmental conditions:
CBA/Ca female mice, nulliparious and non-pregnant. 5 day acclimatisation peroiod. At the start of the study the animals were 8-12 weeks old.

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0, 25, 50, 100%
No. of animals per dose:
4
Details on study design:
A preliminary screening test was done to ascertain the systemic toxicity/irritancy potential of the test material. Based on these results, the top dose was set at 100% (neat material), followed by lower doses at 25% and 50% dilutions in an acetone/olive oil (4:1) mixture.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
2.34
Test group / Remarks:
25% concentration
Parameter:
SI
Value:
3.4
Test group / Remarks:
50% concentration
Parameter:
SI
Value:
6.3
Test group / Remarks:
100% concentration
Parameter:
EC3
Value:
0.406
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: 0% (Vehicle) - 1399.81 25% - 3270.49 50% - 4763.82 100% - 8825.35

Any other information on results incl. tables

Conc

dpm/

node

Test / Control Ratio

Result

Blank

1399.81

N/A

N/A

25%

3270.49

2.34

Negative

50%

4763.82

3.40

Positive

100%

8825.35

6.30

Positive

EC3 value = 40.6%

The draft report is in preparation.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Weston PDDP was sensitising at concentrations of 50% and 100%. The EC3 value is 40.6% from this study.
Executive summary:

While this study indicated that Weston PDDP is a skin sensitiser, the relatively high EC3 value (40.6%) indicates that this substance is not a strong skin sensitiser.