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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:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 16 CFR 1500.11
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Diammonium dihydrogen ethylenediaminetetraacetate
EC Number:
244-063-4
EC Name:
Diammonium dihydrogen ethylenediaminetetraacetate
Cas Number:
20824-56-0
Molecular formula:
C10H16N2O8.2H3N
IUPAC Name:
diammonium dihydrogen 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dutchland Rabbit Farms
- Weight on receipt: 1.6-2.1 kg
- Housing: Standard conditions
- Diet: Big Red Rabbit Chow, ad libitum
- Water: City water, ad libitum
- Acclimation period: 2 week acclimation period

The rabbits were housed and all experiments performed in the facilities of the Vivarium of the University of Rochester School of medicine and dentistry which was accredited by the Association for the Accreditation for Animal care since 1966.

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Remarks:
intact
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg to each test site
Duration of treatment / exposure:
24 hours
Observation period:
One week
Number of animals:
6 male rabbits
Details on study design:
TEST SITE
The animals were clipped on their sides 24 hours before the experiment. Two experimental areas, each measuring 25x25 mm, were prepared on each animal; one site was left intact, the other one abraded by means of shallow incisions through the stratum corneum without causing bleeding.
- Type of wrap if used: 500 mg of the undiluted test material were applied to each test site by means of double layer of surgical gauze which was then covered by overwrapping with pure latex rubber dental dam and the site was immobilized by means of adhesive bandage.

SCORING SYSTEM:
see the attachment 'Scoring System' below.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Remarks:
Animal no.1 to 6 (intact)
Time point:
24 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
Animal no. 1 to 6 (intact)
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
Animal no.1 to 6 (abraded)
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
other: Reversible in 5 animals out of 6 within 3 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
Animal no. 1 to 6 (abraded)
Time point:
72 h
Score:
0.17
Max. score:
4
Reversibility:
other: Reversible in 5 animals out of 6 within 3 days.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
Animal no.1 to 6 (intact)
Time point:
24 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
Animal no.1 to 6 (intact)
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
Animal no.1 to 6 (abraded)
Time point:
24 h
Score:
1.83
Max. score:
4
Reversibility:
other: Reversible in 5 animals out of 6 within 3 days.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
Animal no. 1 to 6 (abraded)
Time point:
72 h
Score:
0.17
Max. score:
4
Reversibility:
other: Reversible in 5 animals out of 6 within 3 days.
Irritant / corrosive response data:
The primary irritation score was 1.75. The score indicates that the test material is not corrosive and dose not cause permanent skin damage under the test conditions. The animals were observed for an additional week. The only observable effect was gradual healing of residual skin changes, if any.
Other effects:
No systemic effects were observed in any of the animals either during the experiment period or afterwards.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met