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Registration Dossier
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EC number: 500-268-3 | CAS number: 87041-44-9
Skin irritation / corrosion
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:
- 2 018
- 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
- Reference substance name:
- 1-[(2-aminocyclohexyl)amino]-3-{4-[2-(4-{3-[(2-aminocyclohexyl)amino]-2-hydroxypropoxy}phenyl)propan-2-yl]phenoxy}propan-2-ol
- Molecular formula:
- C33H52N4O4
- IUPAC Name:
- 1-[(2-aminocyclohexyl)amino]-3-{4-[2-(4-{3-[(2-aminocyclohexyl)amino]-2-hydroxypropoxy}phenyl)propan-2-yl]phenoxy}propan-2-ol
- Reference substance name:
- 1-[(2-aminocyclohexyl)amino]-3-(4-{2-[4-(3-{4-[2-(4-{3-[(2-aminocyclohexyl)amino]-2-hydroxypropoxy}phenyl)propan-2-yl]phenoxy}-2-hydroxypropoxy)phenyl]propan-2-yl}phenoxy)propan-2-ol
- Molecular formula:
- C51H72N4O7
- IUPAC Name:
- 1-[(2-aminocyclohexyl)amino]-3-(4-{2-[4-(3-{4-[2-(4-{3-[(2-aminocyclohexyl)amino]-2-hydroxypropoxy}phenyl)propan-2-yl]phenoxy}-2-hydroxypropoxy)phenyl]propan-2-yl}phenoxy)propan-2-ol
- Reference substance name:
- Cyclohex-1,2-ylenediamine
- EC Number:
- 211-776-7
- EC Name:
- Cyclohex-1,2-ylenediamine
- Cas Number:
- 694-83-7
- Molecular formula:
- C6H14N2
- IUPAC Name:
- cyclohexane-1,2-diamine
- Reference substance name:
- unknown
- Molecular formula:
- unknown
- IUPAC Name:
- unknown
- Test material form:
- liquid: viscous
Constituent 1
Constituent 2
Constituent 3
Constituent 4
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 26 Apr 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 male animal was born on 08 Oct 2016, 05 Nov 2016 or 19 Nov 2016; the female animals were born
on 19 Nov 2016. The pre-test body weight range was 3.2 - 3.5 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:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml per site
- Duration of treatment / exposure:
- Site 2 - 1 h, Site 3 - 4 h,
- Observation period:
- 14 day
- 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 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:
- mean
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: One hour exposure site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: One hour exposure site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: One hour exposure site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: One hour exposure site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: One hour exposure site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within:
- Remarks on result:
- other: One hour exposure site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 1 hour exposure site
- Irritation parameter:
- edema score
- Basis:
- mean
- 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:
- mean
- 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:
- mean
- 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:
- mean
- 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:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 1 hour exposure site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 4 hour exposure site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 4 hour exposure site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 4 hour exposure site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 4 hour exposure site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 4 hour exposure site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 4 hour exposure site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 4 hour exposure site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 4 hour exposure site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 4 hour exposure site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 4 hour exposure site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 4 hour exposure site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 4 hour exposure site
- Other effects:
- No abnormal physical signs were observed.
Applicant's summary and conclusion
- Conclusions:
- In this in vivo OECD 404 study the test substance was tested on rabbit using three test animals. Based on results the test material showed only mild irritanting effects to skin which do not meet the criteria according to EC Regulation 1272/2008 to be classified as irritating to skin.
- Executive summary:
In this in vivo skin irritation study according to OECD 404 three healthy New Zealand White rabbits (one male - two females) were dosed dermally with the test substance.
The test substance (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. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Animals were observed for mortality, toxicological and pharmacological effects at least once daily. Body weights were recorded pre-test and at termination.
No abnormal physical signs were observed.
The test substance is only slightly irritant to skin, which do not meet criteria according EC Regulation 1272/2008 to be classified as "irritating to skin".
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