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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October - November 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is carried out according to a protocol which is equivalent to current guideline, but not compliant with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: HLE protocol number P518/22/6/-/553/s/Rev.1
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
EDTMP-xCaxNa
IUPAC Name:
EDTMP-xCaxNa
Constituent 2
Chemical structure
Reference substance name:
[ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, calcium sodium salt
EC Number:
287-370-9
EC Name:
[ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, calcium sodium salt
Cas Number:
85480-89-3
Molecular formula:
C6H20-2x-yN2O12P4.xCa.yNa
IUPAC Name:
x calcium y sodium {ethane-1,2-diylbis[nitrilobis(methylene)]}tetrakis(phosphonate)
Constituent 3
Reference substance name:
287-89-3
IUPAC Name:
287-89-3
Details on test material:
- Name of test material (as cited in study report): ethylenediamine tetra (methylene phosphonic acid)
- Physical state: white powder
-EDTMP-xCa.xNa 26%, NaCl 12%, and water 62%. Phosphonate content ca. 92%.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: morton Commercial Rabbits, Parsonage Farm, Stansted, Essex
- Weight at study initiation: >2 kg
- Housing: individually housed in grid floor cages in a single room with fan controlled circulation
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 14, lower limit
- Photoperiod (hrs dark / hrs light): natural lighting conditions supplemented with fluorescent lighting during working hours (08.45 - 17.00)

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g


Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 males
Details on study design:
TEST SITE
- Area of exposure: back
- Type of wrap if used: gauze pad under which the test material was held was held in place by a strip of adhesive impermeable plaster which was wrapped around the trunk of the animal.

SCORING SYSTEM: Draize, 1959

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin, six animals
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin, six animals
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
0.2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: abraded skin, six animals
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: abraded skin, six animals
Irritant / corrosive response data:
The sum of 24 hour and 72 hour values for erythema and oedema on intact and abraded skin (48 scores) were divided by 24 to give the primary irritation index of the test article. 0 = non-irritant, >0-2 = slight, >2-5 = moderate, >5 = severe.
Very slight erythema was noted in 2 abraded sites at the 24 hour observation. One abraded site also showed very slight oedema at this time. The skin was normal at the 72 hour observation. A primary irritation index of 0.1 was obtained. Test article is therefore considered a slight skin irritant in this report.
Other effects:
None reported.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
All readings were 0 at 24 and 72 hours when test material was applied onto intact skin, as reported in a study conducted according to a protocol which is equivalent to current guideline but not compliant with GLP. The result would not trigger classification according to current regulation (EC 1272/2008).