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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl tolyl ether
EC Number:
282-199-6
EC Name:
1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl tolyl ether
Cas Number:
84144-79-6
Molecular formula:
C14H26N3O2
IUPAC Name:
1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl tolyl ether
Test material form:
liquid: viscous
Details on test material:
Manufacturer Air Products and Chemicals
Batch # 8418406

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Animals were received from Covance Research Products Inc., Denver, PA, on 11 Jan 2017. Following an acclimation period of at least five days. three healthy New Zealand White rabbits (one male -two females) were selected from a larger group without conscious bias.
The animals were born on 03 Sep 2016 and 10 Sep 2016. The pre-test body weight range was 3.0 -3.2 kg.
The animals were identified by cage notation and a uniquely numbered metal ear tag and individually housed in suspended wire-bottom cages. Absorbent paper bedding was placed beneath the cages and changed at least three times per week. Fresh PMI Rabbit Chow (Diet No.5321) was provided daily. Water was available ad libitum. The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12 hour light/dark cycle, and was kept clean and vermin free.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml per site
Duration of treatment / exposure:
1h/4h
Observation period:
14 days
Number of animals:
3
Details on study design:
Site Preparation
Approximately 24 hours prior to application of the test article, the dorsal area of the trunk of each animal was clipped free of hair. The prepared site was approximately 10% of the body surface and remained intact.
Dosing
The test article (0.5 ml) was applied dermally to two intact sites per rabbit. The test article was kept in contact with the skin for one hour (site 2) and four hours (site 3) at which time the wrappings were removed.
The test article was dosed by volume, 0.5 ml for one hour (site 2) and four hours (site 3) and placed over a 2 x 3 cm gauze patch. Gentle pressure was applied to aid in the distribution of the test article over the prepared site. The patches were secured with non-irritating tape. The test article was kept in contact with the skin for one and four hours at which time the wrappings and patches were removed. The sites were gently washed with gauze saturated with distilled water. The outline of the dose site was marked using an indelible marker.
Type and Frequency of Observations
The exposure sites were scored for dermal irritation at 1, 24, 48 and 72 hours and on Days 7 and 14. Erythema and edema were scored according to the numerical Draize1 scale below. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction. Additional signs were described.
Erythema and Eschar
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Edema
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well-defined by definite raising) 2
Moderate edema (raised approximately 1.0 mm) 3
Severe edema (raised more than 1.0 mm, extending beyond the area of exposure) 4
Body weights were recorded pre-test and at termination.
Animals were observed for mortality, toxicological and pharmacological effects at least once daily. All animals were humanely euthanized with a 1 ml intravenous injection (via the marginal ear vein) of Fatal-Plus® following study termination.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
1 h exposure
Basis:
mean
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
1 h exposure
Basis:
mean
Time point:
48 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
1 h exposure
Basis:
mean
Time point:
72 h
Score:
3.3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
1 h exposure
Basis:
mean
Time point:
24 h
Score:
3.3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
1 h exposure
Basis:
mean
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
1 h exposure
Basis:
mean
Time point:
72 h
Score:
2.3
Max. score:
7
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
mean
Time point:
24 h
Score:
3.7
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
mean
Time point:
48 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
mean
Time point:
72 h
Score:
3.3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
4 h exposure
Basis:
mean
Time point:
24 h
Score:
3.3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
4 h exposure
Basis:
mean
Time point:
48 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
4h exposure
Basis:
mean
Time point:
72 h
Score:
3.3
Max. score:
4
Reversibility:
not reversible
Other effects:
No abnormal physical signs were observed. One animal gained weight and two animal’s weight remained the same by study termination.

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl tolyl is assighend classification for corrosivity Category 1C based on Acute Dermal Corrosion study in Rabbits.
Executive summary:

Three healthy New Zealand White rabbits (one male - two females) were dosed dermally with 1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl tolyl ether batch 8418406. The test article (0.5 ml) was applied dermally to two intact sites per rabbit. The test article was kept in contact with the skin for one hour (site 2) and four hours (site 3) at which time the wrappings were removed. Erythema and edema were scored at 1, 24, 48 and 72 hours and again on Days 7 and 14. Based on the test results, material is assighend classification for corrosivity Category 1C.