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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible tor the test
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 84/449/EWG, 8.6 (Meerschweinchen-Maximierungstest (GPMT))
Principles of method if other than guideline:
84/449/EWG, 8.6 (Meerschweinchen-Maximierungstest (GPMT))
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone
EC Number:
404-360-3
EC Name:
2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone
Cas Number:
119313-12-1
Molecular formula:
C23H30N2O2
IUPAC Name:
2-benzyl-2-(dimethylamino)-1-[4-(morpholin-4-yl)phenyl]butan-1-one

In vivo test system

Test animals

Species:
guinea pig

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
1st stage: 0.1 ml FCNSaline (1:1) intradermally at 4 sites,
then about 0.4 g of 30% test substance in vaseline applied
topically by occlusive patch over these sites.
2nd stage: about 0.4 g of 30% test substance in vaseline
applied topically by occlusive patch over same injection
sites. .
Concentration of test material and vehicle used for each challenge:
10% in vasleine
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
1st stage: 0.1 ml FCNSaline (1:1) intradermally at 4 sites,
then about 0.4 g of 30% test substance in vaseline applied
topically by occlusive patch over these sites.
2nd stage: about 0.4 g of 30% test substance in vaseline
applied topically by occlusive patch over same injection
sites. .
Concentration of test material and vehicle used for each challenge:
10% in vasleine

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 10 %

Signs of irritation during induction:

Keine Befunde

"ENGLISH"

No findings

Evidence of sensitisation of each challenge concentration:

Keine

"ENGLISH"

None

Other observations:

Bei dem Vortest wurde bei einem der vier Tiere Erythema

beobachtet (wahrend 24 h nach der occlusiven Applikation von

30 % der Testsubstanz in Vaseline) .

"ENGLISH"

Erythema was observed in one of the four animals in the

pretest (during 24 h after the occlusive application of 30%

of the test substance in vaseline) .

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information