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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide
EC Number:
423-340-5
EC Name:
Phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide
Cas Number:
162881-26-7
Molecular formula:
C26H27O3P
IUPAC Name:
[phenyl(2,4,6-trimethylbenzoyl)phosphoryl](2,4,6-trimethylphenyl)methanone

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: acetone and Alembicol D
Concentration / amount:
0.1 ml of the test substance (1% w/v) in 5% acetone in Alembicol D
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: acetone and Alembicol D
Concentration / amount:
0.1 ml of the test substance (1% w/v) in 5% acetone in Alembicol D
No. of animals per dose:
5 control animals: 10 test animals
Details on study design:
MAIN STUDY

A. INDUCTION EXPOSURE

DAY O:
- Test groups: 10 animals
- No. of exposures: 3 intradermal injections on day 0
- 0.1 ml of Freund's complete adjuvant (FCA) in distilled water,
- 0.1 ml of the test substance (1% w/v) in 5% acetone in Alembicol
- 0.1 ml of the test substance (1% w/v) in 50% aqueous FCA (50%) and 5% in acetone in Alembicol
- Control group: 5 animals given the same injections without the test substance

DAY 6: topical application site treated with 10% (w/v sodium lauryl sulphate in petrolatum

DAY 7
- 0.4 ml of the test substance in acetone (70%) was applied to the skin of each animal and held in place for 48 hours using semi-occlusive wrap

Control animals treated in the same manner without the test substance.

B. CHALLENGE EXPOSURE

Both control and test animals challenged topically 2 weeks after the topical inductin application using the test substance, 35% w/v (posterior site) and 70% w/w (anterior site) in acetone. Application with semi-occlusive wrap for 24 hours. Evaluation at 24, 48 and 72 hours after challenge.


Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
35%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 35%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
70%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 70%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
35%
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 35%. No with. + reactions: 3.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
70%
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 70%. No with. + reactions: 5.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
35%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 35%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
70%
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 70%. No with. + reactions: 3.0. Total no. in groups: 10.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance showed evidence of skin sensitiation in the Guinea Pig Maximisation Test.