Registration Dossier

Administrative data

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:
other: Comparable to guideline study with deficiencies in reporting.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material : BMDBM

In vivo test system

Test animals

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: 300-450g
- Housing: Type 3 wire mesh cages
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 45 ± 10%
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: 2-phenylethanol
Concentration / amount:
Induction:
day 0: 5% in FCA
day 8: 20% in 2-phenylethanol

Challenge:
day 21: 20% and 6% in 2-phenylethanol
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 2-phenylethanol
Concentration / amount:
Induction:
day 0: 5% in FCA
day 8: 20% in 2-phenylethanol

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 24h.
- Site: flank
- Evaluation: 24 and 48h after removing the patch
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Results
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
Clinical observations:
no data
Remarks on result:
other: Reading: other: mean of two readings after 24 and 48h. . Hours after challenge: 48.0. Group: test group. Dose level: 6% and 20%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information as the positive response is < 30%
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 the number of positive results is 0 in a group of 20 treated animals, no classification as skin sensitising according to OECD GHS 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 OECD GHS is needed.