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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05/11/2003-21/11/2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
453-090-2
EC Name:
-
Cas Number:
140456-78-6
Molecular formula:
NH4 N(NO2)2
IUPAC Name:
Ammonium dinitroazanide
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- batch No.of test material: 2003 7026
- Expiration date of the lot/batch: 31/12/2013
- Purity test date: > 99%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stored in dark closed containers at room temperature (20°C+/- 3°C) in places approved for explosives.
- Stability under test conditions: ADn is to be considered very sensitive to shock but low sensitive to friction and sparks.

In vivo test system

Test animals

Species:
mouse
Strain:
CBA:J
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 wks (beginning of acclimatization)
- Weight at study initiation: 16-24 gr
- Housing: Individual in makrolon type-2 cages with standard softwood bedding.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/ 12

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
5%, 10% and 25%
No. of animals per dose:
16 females, 4 per group

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
1.2
Test group / Remarks:
group 2
Remarks on result:
other: Test item concentration 5% (w/v)
Parameter:
SI
Value:
0.8
Test group / Remarks:
gruop 3
Remarks on result:
other: Test item concentration 10% (w/v)
Parameter:
SI
Value:
1.2
Test group / Remarks:
group 4
Remarks on result:
other: Test item concentration 25% (w/v)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In this study STIMULATION INDICES of 1.2, 0.8 and 1.2 were determined with the test item at concentrations of 5%, 10% and 25% (w/v) in acetone:olive oil, 4:1 (v/v).
A test item is regarded as a sentitizer in the LLNA if the exposure to one or more test concentrations resulted in 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the STIMULATION INDEX (S.I).
The test item ADN was found to be a non -sensitizer when tested at up to the highest achivable concentration of 25% (w/v) in acetone:olive oil, 4:1 (v/v).