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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

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
Study period:
01/2008 to 04/2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test report was already available.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 07072601
- Expiration date of the lot/batch: 26.07.2008

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no

FORM AS APPLIED IN THE TEST (if different from that of starting material): powder
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (F-69592 L' Arbresle)
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: 4 weeks
- Weight at study initiation: 240 to 258 g
- Housing: groups of 2 or 3 animals, in polycarbonate containers
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 22
- Humidity (%): 36 to 58
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal
Vehicle:
water
Concentration / amount:
8.75%
Day(s)/duration:
20
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
20% and 40%
Day(s)/duration:
1
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 treated animals
5 control animals
Details on study design:
RANGE FINDING TESTS:
Determination by intradermal injection of the Maximal Non Necrotizing Concentration (MNNC)
Determination by topical application of the Pre-Maximal Non Irritant Concentration (PreMNIC)
Determination by topical application of the Maximal Non Irritant Concentration (MNIC)

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3x2
- Test groups: 1 (10 animals)
- Control group: 1 (5 animals
- Site: scapular zone

B. CHALLENGE EXPOSURE
- No. of exposures: 1x2
- Day(s) of challenge: 1
- Exposure period: 1
- Test groups: 1 (15 animals)
- Control group: 0
- Site: dorso-lumbar zone
- Evaluation (hr after challenge): 24 and 48
Positive control substance(s):
yes
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
40%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No cutaneous intolerance reaction
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
40%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No cutaneous intolerance reaction
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
20%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No cutaneous intolerance reaction
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
20%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No cutaneous intolerance reaction
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
40%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No macroscopic cutaneous reactions attributable to allergy
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
40%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No macroscopic cutaneous reactions attributable to allergy
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No macroscopic cutaneous reactions attributable to allergy
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No macroscopic cutaneous reactions attributable to allergy

No macroscopic cutaneous reactions attributable to allergy were recorded during the examination following the removal of the occlusive dressing (challenge phase) from the animals of the treated group with the test item.

No cutaneous intolerance reaction was recorded in animals from the negative control group.

Interpretation of results:
GHS criteria not met
Conclusions:
In view of the results, under these experimental conditions, the test item Bromo(hexahydro-2Hazepin-2-onato-N)magnesium needs not to be classified, in accordance with the criteria for classification of regulation (EC) No. 1272/2008 needs not to be classified.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Under the experimental conditions, the test item Bromo(hexahydro-2Hazepin-2-onato-N)magnesium needs not to be classified, in accordance with the criteria for classification of regulation (EC) No. 1272/2008.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No classification as "Skin. Sens." according to test data.

No classification as "Resp. Sens." according to absence of evidence.