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Administrative data

Description of key information

Butyl methoxydibenzoylmethane (BMDBM) showed no skin sensitising potential in a GMPT study on guinea pigs.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Comparable to guideline study with deficiencies in reporting.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
: no grading but only sensitisation-positive animals were reported.
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was performed in 1982.
Species:
guinea pig
Strain:
Himalayan
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Institute of biological research, Fuellingsdorf, Switzerland
- Weight at study initiation: 300 - 450 g
- Housing: Type 3 wire mesh cages
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 45 ± 10 %
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal and epicutaneous
Vehicle:
other: 2-phenylethanol
Concentration / amount:
Induction:
day 0: 5 % in FCA
day 8: 20 % in 2-phenylethanol
Route:
epicutaneous, occlusive
Vehicle:
other: 2-phenylethanol
Concentration / amount:
Challenge:
day 21: 20 % and 6 % in 2-phenylethanol
No. of animals per dose:
Experimantal group: 20 animals
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
On day 0, each of the 20 animals received 2 intradermal injections of either the test item, FCA, or FCA + test item. On day 8, occlusive topical application of the test item for 2 days was performed.
- Site: neck

B. CHALLENGE EXPOSURE
On day 21, an occlusive patch with the test item (20 % and 6 %) in 2-phenylethanol was applied for 24 h.
- Site: flank
- Evaluation: 24 and 48 h after removing the patch
Positive control substance(s):
no
Key result
Reading:
other: mean of two readings after 24 and 48h
Hours after challenge:
48
Group:
test group
Dose level:
6 % and 20 %
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested
Reading:
1st reading
Group:
negative control
Remarks on result:
not measured/tested
Interpretation of results:
GHS criteria not met
Conclusions:
The occlusive challenge with BMDBM, 20 % and 6 % in 2-phenylethanol 3 weeks after the initial injections does not elicit allergic reactions in guinea pigs. As the number of positive results is 0 in a group of 20 treated animals, no classification as skin sensitiser is needed.
Executive summary:

The occlusive challenge with BMDBM, 20 % and 6 % in 2-phenylethanol 3 weeks after the initial injections does not elicit allergic reactions in guinea pigs.

As the the number of positive results is 0 in a group of 20 treated animals, no classification as skin sensitising according to GHS and CLP is needed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

One assay on skin sensitisation of butyl methoxydibenzoylmethane (BMDBM) was provided:

A GPMT was performed on guinea pigs. BMDBM did not show any sensitising potential. It can therefore be concluded beyond any reasonable doubt that topical application of BMDBM is not likely to cause skin sensitization.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified as a skin sensitizer under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.