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Diss Factsheets

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:
2016
Report date:
2016

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:
4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with 4,4'-methylenebis(cyclohexylamine)
EC Number:
500-103-5
EC Name:
4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with 4,4'-methylenebis(cyclohexylamine)
Cas Number:
38294-67-6
Molecular formula:
C
IUPAC Name:
Reaction products of 4,4'-methylenebis(cyclohexylamine) and 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane
Test material form:
liquid: viscous
Details on test material:
Sample ID :PACM BADGE adduct
Chemical Name :4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with 4,4'-methylenebis(cyclohexylamine)
Physical State liquid
CAS # 38294-67-6
EU # 500-103-5
Manufacturer Air Products and Chemicals, Inc.
Batch # / Lot # 20160226-PDU-PACM 828

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 06 Apr 2016. Following an
acclimation period of at least five days, one healthy New Zealand White rabbit (male) was selected from a
larger group without conscious bias.
The animal was born on 21 Nov 2015. The pre-test body weight was 3.2 kg.
The animal was 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 #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:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g per site
Duration of treatment / exposure:
Site 2 - 1 h, Site 3 - 4 h,
Observation period:
14 day
Number of animals:
1
Details on study design:
Site Preparation
Approximately 24 hours prior to application of the test article, the dorsal area of the trunk of the animal
was clipped free of hair. The prepared site was approximately 10% of the body surface and remained
intact.
Dosing
One rabbit was dosed on Site 2 for an exposure period of one hour and Site 3 for an exposure period of
four hours. The test article was individually weighed, 0.5 g per site and applied over a 2 x 3 cm gauze
patch at which time the test article solidified. Gentle pressure was applied to aid in the distribution of the
test article over the prepared site. The clipped area of the torso was covered with a piece of porous
dressing large enough to cover both dose sites with at least 5 cm2 to spare on all sides of the gauze
patch. Porous, non-irritating tape was used to encircle the trunk of the animal. After the exposure
periods, the wrapping and patches were removed and the sites were gently washed with gauze saturated
with 70% isopropyl alcohol. The outline of the dose sites were marked using an indelible marker.
Type and Frequency of Observations
Site 2 (one-hour exposure) and 3 (four-hour exposure) were scored for dermal irritation at 1, 24, 48 and
72 hours after patch removal and again on Days 7 and 14. Erythema and edema were scored according
to the numerical Draize1 scale. The skin was also evaluated for ulceration and necrosis or any evidence
of tissue destruction. Additional signs were described.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: One hour exposure site
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: One hour exposure site
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: One hour exposure site
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: One hour exposure site
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
7 d
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: One hour exposure site
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
14 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: One hour exposure site
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 1 hour exposure site
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 1 hour exposure site
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 1 hour exposure site
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 1 hour exposure site
Irritation parameter:
edema score
Basis:
animal #1
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 1 hour exposure site
Irritation parameter:
edema score
Basis:
animal #1
Time point:
14 d
Score:
0
Max. score:
4
Remarks on result:
other: 1 hour exposure site
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 4 hour exposure site
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 4 hour exposure site
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 4 hour exposure site
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 4 hour exposure site
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
7 d
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 4 hour exposure site
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
14 d
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 4 hour exposure site
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 4 hour exposure site
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 4 hour exposure site
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 4 hour exposure site
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 4 hour exposure site
Irritation parameter:
edema score
Basis:
animal #1
Time point:
7 d
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 4 hour exposure site
Irritation parameter:
edema score
Basis:
animal #1
Time point:
14 d
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 4 hour exposure site
Other effects:
No abnormal physical signs were observed. The animal gained body weight by study termination.

Applicant's summary and conclusion

Conclusions:
Corrosivity of PACM BADGE was tested on rabbit using one test animal. Based on results the test material is corrosive to skin meeting criteria of catagory Corr 1C.
Executive summary:

Corrosivity of PACM BADGE was tested on rabbit using one test animal. Based on results the test material is corrosive to skin meeting criteria of catagory Corr 1C.