Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Testing conducted prior to REACH regulations.

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(2-methyloctyl)phenyl bis(4-nonylphenyl) phosphite
EC Number:
701-028-2
Cas Number:
26523-78-4
Molecular formula:
C45H69O3P
IUPAC Name:
4-(2-methyloctyl)phenyl bis(4-nonylphenyl) phosphite
Constituent 2
Reference substance name:
Nonylphenol
EC Number:
246-672-0
EC Name:
Nonylphenol
Cas Number:
25154-52-3
IUPAC Name:
2-nonylphenol
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Induction phase : 0.4 ml
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Induction phase : 0.4 ml
No. of animals per dose:
38
Details on study design:
MAIN STUDY1st application: Induction undiluted occlusive epicutaneous 2nd application: Challenge undiluted occlusive epicutaneous Induction phase : 0.4 ml of the test substance, undiluted, was applied once per week for 3 consecutive weeks (Day 0,7 and 14) on one side of the animal, directly to the skin and covered with a gauze pad of approximately 4-6 cm2. The positive control substance, dinitrochlorobenzene (DNCB), was applied in the same manner. Naive animals (i.e. untreated during the induction phase) served as a negative control. CHALLENGE EXPOSUREThe skin was exposed to the test substance for 6 hours in the same way as for the induction phase. At approximately 21 hours after removal of the challenge dose, the area of the challenge was marked and the whole back shaved. Approximately 3 hours after shaving, the test site was examined for erythema and edema. Reading of the skin area was repeated at approximately 48 hours after removal of the challenge dose and the skin reactions were graded.
Positive control substance(s):
yes
Remarks:
dinitrochlorobenzene (DNCB)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.4 mL undiluted
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Remarks:
All scores were 0
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.4 mL undiluted
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

-

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The results of the study were negative for skin sensitisation.
Executive summary:

TNPP (neat; 100% concentration) was negative for skin sensitisation in this Buehler assay.