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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP study according to the experimental procedures described in 16 CFR 1500.11. For read-across justification refer to section 13.

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hampene Diammonium EDTA 40%
- Physical state: Clear colorless liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dutchland Rabbit Farms
- Weight on receipt: 1.6-2.1 kg
- Housing: Standard conditions
- Diet (e.g. ad libitum): Big Red Rabbit Chow ad libitum
- Water (e.g. ad libitum): 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:
other: intact and abraded
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 25*25 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:
other: 24
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:
other: 72
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:
other: 24
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:
other: 72
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:
other: 24
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:
other: 72
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:
other: 24
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:
other: 72
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is classified as not irritating to skin according to EU criteria.
Executive summary:

A sample of the test material (a clear colorless liquid) was submitted for primary skin potential in rabbits according to the experimental procedures described in 16 CFR 1500.11 (formerly 21 CFR 191.11).

 

6 male New Zealand White albino rabbits weighing between 1.6 and 2.1 kg on receipt were used. Animals were acclimatized were for a two week period and were maintained on Big Red Rabbit Chow and city water ad libitum.

 

The animals were prepared by clipping their sides with an electric clipper 24 hours before the experiment. Two experimental areas, each measuring 25×25 mm, were prepared on each animal; one site was left intact, the other one was baraded by means of shallow incisions through the stratum corneum without causing bleeding.

 

500 mg of the undiluted test material were applied to each test site by means of a double layer of surgical gauze which was then covered by over wrapping with pure latex rubber dental dam and the site was immobilized by means of adhesive bandages.

 

All bandages, sheeting, gauze, etc. were removed 24 hours after application. All skin changes, if any, were observed, scored and recorded according to the prescribed procedure at this time, and again at 72 hours after the time of application. The animals were then observed for an additional week. The only observable effect was gradual healing of residual skin changes, if any.

 

No systemic effects were observed in any of the animals, either during the experimental period or afterwards.

 

The primary dermal irritation score was 1.75. So the test material is classified as not irritating to skin according to EU criteria.