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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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: Guideline study with GLP
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Maximisation test of Magnusson and Kligman
Principles of method if other than guideline:
There is no need to add in this field.
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
425-220-8
EC Name:
-
Cas Number:
5945-33-5
Molecular formula:
C39H34O8P2
IUPAC Name:
(1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate
Details on test material:
75 - 95% (typical 88%, verified by UV/visible spectrum, Infrared (IR) spectrum, Nuclear Magnetic Resonance (NMR), and Mass spectrum.)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
no data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Concentration / amount:
Day 1 – intradermal induction
Hair was removed from the shoulder region of animals and a row of three injections was made on each side of the midline.
Injections were
1:1 (v/v) Freunds Complete Adjuvant (FCA):water
5% (w/v) test substance in arachis oil
5% (w/v) test substance in a 1:1 preparation of FCA plus distilled water
Day 8 – topical induction
A patch containing test substance (75% w/w in arachis oil) was applied to the same site and secured with tape for 48 hours.
Day 22
Doses of 50 and 75% w/w of test substance in arachis oil were applied to the prepared flank of animals and secured under occlusive conditions.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Concentration / amount:
Day 1 – intradermal induction
Hair was removed from the shoulder region of animals and a row of three injections was made on each side of the midline.
Injections were
1:1 (v/v) Freunds Complete Adjuvant (FCA):water
5% (w/v) test substance in arachis oil
5% (w/v) test substance in a 1:1 preparation of FCA plus distilled water
Day 8 – topical induction
A patch containing test substance (75% w/w in arachis oil) was applied to the same site and secured with tape for 48 hours.
Day 22
Doses of 50 and 75% w/w of test substance in arachis oil were applied to the prepared flank of animals and secured under occlusive conditions.
No. of animals per dose:
no data
Details on study design:
no data
Challenge controls:
Control animals were treated in a similar manner to test animals excluding the test substance.
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Vehicle:
other: not conducted
Concentration:
not conducted
No. of animals per dose:
not conducted
Details on study design:
no data
Positive control substance(s):
not specified
Statistics:
no data

Results and discussion

Positive control results:
no data

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
no data
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin reactions were noted at the challenge sites of test
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: no data. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No skin reactions were noted at the challenge sites of test .
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
no data
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No skin reactions were noted at the challenge sites of test
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: no data. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No skin reactions were noted at the challenge sites of test .
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
no data
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin reactions were noted at the challenge sites of test
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: no data. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No skin reactions were noted at the challenge sites of test .
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
no data
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No skin reactions were noted at the challenge sites of test
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: no data. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No skin reactions were noted at the challenge sites of test .

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: not conducted
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: not conducted

Any other information on results incl. tables

One test group animal was killed due to weight loss and breathing difficulties on day 16. These effects were not considered to be treatment-related.

No skin reactions were noted at the challenge sites of test and control animals at the 24 and 48-hour observations.

No adverse effects on bodyweight gain were noted.

The test chemical was non-sensitising to the skin of guinea pigs

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test chemical was non-sensitising to the skin of guinea pigs.
Executive summary:

According to OECD TG 406, Maximisation test of Magnusson and Kligman was accomplished and concluded that test material did not induce skin sensitisation in guinea pigs.