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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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)
Rationale for reliability incl. deficiencies:
other: Part of the SNIF file, which was accepted by the Belgian national authority for NONS.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EEC Directive 96/54, B.6 Maximization test
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
441-100-8
EC Name:
-
Cas Number:
351197-46-1
Molecular formula:
Hill formula: C24 H48 N4 O6 CAS formula: C24 H48 O6 N4
IUPAC Name:
2-[2-(dimethylamino)ethoxy]ethyl N-{[1,3,3-trimethyl-5-(9-methyl-2-oxo-3,6-dioxa-1,9-diazadecan-1-yl)cyclohexyl]methyl}carbamate

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Albino, not further specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal injection (0.1 ml/site)

a) 1:1 (v/v) mixture of Freund's Complete Adjuvant and
physiological saline.

b) Test item at 10% in purified water.

c) Test item at 10% in a 1:1 (v/v) mixture of Freund's
Complete Adjuvant and physiological saline.


Epidermal testing:

Test item 75% in purified water.

Concentration of test material and vehicle used for each challenge:
Epidermal application (75% in purified water, 0.2 ml)
Challengeopen allclose all
Route:
other: epicutaneous
Vehicle:
water
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal injection (0.1 ml/site)

a) 1:1 (v/v) mixture of Freund's Complete Adjuvant and
physiological saline.

b) Test item at 10% in purified water.

c) Test item at 10% in a 1:1 (v/v) mixture of Freund's
Complete Adjuvant and physiological saline.


Epidermal testing:

Test item 75% in purified water.

Concentration of test material and vehicle used for each challenge:
Epidermal application (75% in purified water, 0.2 ml)
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75 %
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 %. No with. + reactions: 9.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0 %
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: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75 %
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75 %. No with. + reactions: 9.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75 %
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: 75 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
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:
negative control
Dose level:
75 %
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: 75 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
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.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 75 %

Signs of irritation during induction:
The expected and common findings were observed in the
control and test group after the different applications
using FCA intradermally. These findings consisted of
erythema, oedema, necrotizing dermatitis, encrustation and
exfoliation of encrustation.

Ventral recumbency and tremor were observed in 4 test
animals approximately 3 hours after the intradermal
induction application. The 75% concentration of the test
item used for the challenge application was non-irritant and
was the maximum concentration attainable.

The animals of the test and control groups were all
pretreated with 10% SLS approx. 21 hours before the
epidermal induction. After the epidermal induction

application, discrete/patchy to moderate/confluent erythema

in the test (all animals) and control (2 animals) group was

observed.

Evidence of sensitisation of each challenge concentration:
Concentration 75%: 9/9 (100%) of the animals showed
sensitisation. Discrete/patchy to moderate/confluent
erythema were observed in all animals at the 24- and 48-hour
reading after treatment with the test item at 75% in
purified water. No skin reactions were observed in the
animals when treated with purified water only.

Other observations:
One animal of the control group was found dead on test day
11 and one animal of the test group was found dead on test
day 1 after the intradermal induction. No macroscopic

findings were noted.

The animal of the test group found dead on day 1 showed a
loss of body weight (8%) during the acclimatization

period. The body weight of the other animals was within the

range commonly recorded for animals of this strain and age.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information