Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
12.01. - 11.02.2005.
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
other: Skin Sensitisation
Justification for non-LLNA method:
According to EU Method B.6 (Skin Sensitisation)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
463-070-5
EC Name:
-
Cas Number:
106966-25-0
Molecular formula:
C7H17N2O2Br
IUPAC Name:
2-(3-methoxy-3-oxopropyl)-1,1,1-trimethylhydrazinium bromide

In vivo test system

Test animals

Species:
other: Albino guinea pig
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Concentration / amount:
Concentration of test material and vehicle used at induction:
intradermal induction: 0.1% test substance in water for injection
topical induction: 10% test substance in vaseline

Concentration of test material and vehicle used for each challenge:
chalenge- topical application: 0.5% test substance in vaseli ne
Challengeopen allclose all
Route:
intradermal
Concentration / amount:
Concentration of test material and vehicle used at induction:
intradermal induction: 0.1% test substance in water for injection
topical induction: 10% test substance in vaseline

Concentration of test material and vehicle used for each challenge:
chalenge- topical application: 0.5% test substance in vaseli ne
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:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
%
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: %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
%
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: %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
other: No information about positive control group.
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 1 %
The evaluation of skin reactions of exposed group showed the erythema and oedema the subsided time 48 hours.

The evaluation of skin reactions in control group showed only the marked sites of intradermal injections.

Topical application:
The evaluation of skin reations of exposed group showed in all animals the discrete confluent erythema without oedema in the test area with fade-out time 48 hours. The evaluation of skin reactions in control group with vaseline did not show any changes in skin of all animals.

Evidence of sensitisation of each challenge concentration:
The exposed animals in main study showed no allergic skin reactions and no other negative clinical symptoms throughout
the experiment.

Other observations:
In pilot test concentration 20%, 10% and 5% of test substance in water for injection by intradermal injections caused death of all three animals. Vehement serous discharges out of eyes, hard breathing and decelerated
motion were observed in other 2 animals immediatelly after application of 1% and 0.5% test substance. Slight hydrous
discharge out of eyes only was observed after application of 0.1% test substance. All alterations faded away within 1
hour after application.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Conclusions:
The exposed animals in main study showed no allergic skin reactions and no other negative clinical symptoms throughout the experiment with guinea pig.
Alterations after application of the test substance were observed in animals in pilot study. Application 20%, 10% and 5% test substance in water for injection by intradermal injections caused death of all 3 females. Animals died within 5 minutes after application. Concentration of the test substance was reduced and applied to other three animals. Vehement serous discharges out of eyes, hard breathing (gasping) and decelerated motion were observed in 2 males immediately after application 1% and 0.5% test substance. Slight hydrous discharge out of eyes only, was observed in male after application 0.1% test substance. All alterations faded away within 1 hour after application.
The body weight of animals increased throughout the study and it was not affected by the treatment. In the course of experiment the animals did not show any clinical symptoms of intoxication.
The test substance was not shown to be a contact allergen in guinea pig.