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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2007-12-03 till 2007-12-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
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:
483-300-8
EC Name:
-
Cas Number:
99580-93-5
Molecular formula:
Hill formula: C3H13N2O3P CAS formula: C2H8N2.CH5O3P
IUPAC Name:
1,2-Ethanediamine methylphosphonate
Test material form:
solid: bulk
Details on test material:
Batch number: FEB 278-810

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
Mice, CBA/Ca01aHsd, female, age 8 – 12 weeks, 5 mice per test group.

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
A preliminary test was performed first to detect the highest application solution. The maximum technically applicable concentration was found to be 50%. Based on the results of this preliminary test the test item was assayed at three concentrations: 12,5%, 25%, 50% (w/v).
No. of animals per dose:
5 mice per test group; 3 test groups (3 different concentrations) and 1 Negative Control Group (vehicle) were tested.
Positive control substance(s):
other: p-Phenylenediamine

Results and discussion

Positive control results:
The stimulation index observed in the historical positive control group of the BSL study no. 073846 with 1% p-Phenylendiamine was 8.1.

In vivo (LLNA)

Results
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Table 3: Radioactive determination of the test substance groups. If not noted individually, results include both lymph nodes of an animal.

Any other information on results incl. tables

Summary Results:

None of the three tested concentrations of the test item reached the stimulation index of 3.

The stimulation index at a concentration of 12.5% was 0.8

The stimulation index at a concentration of 25% was 0,7

The stimulation index at a concentration of 50% was 0.9

Weight development of all animals was within the expected range, which includes a weight loss of up to 2 g throughout the study.

At the daily clinical observation the animals did not show any visible clinical symptoms.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The EC3 value (derived by linear interpolation) could not be stated, as all measure points were below the stimulation index of three.
Considering the reported data of this sensitization test it can be stated that the test item causes no reactions identified as sensitization, as the stimulation index was below 3.0 for each concentration tested.