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Registration Dossier
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EC number: 947-984-6 | CAS number: -
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:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Phenol, 4,4'-(1-methylethylidene)bis-, polymer with (chloromethyl)oxirane, reaction products with diethylenetriamine and 4-methyl-2-pentanone in xylene and butanol
- EC Number:
- 947-984-6
- Molecular formula:
- The substance is a UVCB, of which a major component can be represented by the following: C28H46ClN3O4
- IUPAC Name:
- Phenol, 4,4'-(1-methylethylidene)bis-, polymer with (chloromethyl)oxirane, reaction products with diethylenetriamine and 4-methyl-2-pentanone in xylene and butanol
- Reference substance name:
- Phenol, 4,4'-(1-methylethylidene)bis-, oligomer with (chloromethyl)oxirane, reaction products with diethylenetriamine and 4-methyl-2-pentanone, n=2
- IUPAC Name:
- Phenol, 4,4'-(1-methylethylidene)bis-, oligomer with (chloromethyl)oxirane, reaction products with diethylenetriamine and 4-methyl-2-pentanone, n=2
- Reference substance name:
- 1,2-xylene; 1,3-xylene; 1,4-xylene; ethylbenzene
- EC Number:
- 905-588-0
- Molecular formula:
- C32H40
- IUPAC Name:
- 1,2-xylene; 1,3-xylene; 1,4-xylene; ethylbenzene
- Reference substance name:
- Butan-1-ol
- EC Number:
- 200-751-6
- EC Name:
- Butan-1-ol
- Cas Number:
- 71-36-3
- Molecular formula:
- C4H10O
- IUPAC Name:
- butan-1-ol
- 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:
- Details on test animals and environmental conditions
TEST ANIMALS
- Source: ENKI-Konijnenfarm, Someren, the Netherlands
- Age at study initiation: young adult
- Weight at study initiation: 2500-3500 gram
- Housing: animals were housed individually in suspended, galvanized cages, fitted with wired-mesh
floor and front
- Diet: standard laboratory rabbit diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: six days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3 ºC
- Humidity (%): 40 to 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: not reported
Test system
- Type of coverage:
- other: both occlusive and non-occlusive application
- Preparation of test site:
- other: both intact and abraded skin after clipping
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL of undiluted test material - Duration of treatment / exposure:
- 4 h
- Observation period:
- 4, 28, 52 and 76 h after application of test substance
- Number of animals:
- 6 per exposure group
- Details on study design:
- TEST SITE
- Area of exposure: 1x1 inch for occlusive expousre
- % coverage:
- Type of wrap if used: surgical patch fixed with adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing: test substance was removed after 4 h, method not specified
OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 4, 28, 52 and 76 h after initial exposure
SCORING SYSTEM:
- Method of calculation: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- open test
- Basis:
- mean
- Time point:
- other: 4 and 52 hours
- Score:
- 2.4
- Reversibility:
- fully reversible within: 20 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- closed patch test
- Basis:
- mean
- Time point:
- other: 4 and 52 hours
- Score:
- 4.2
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Open test - intact skin
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Open test - intact skin
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Open test - intact skin
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- Open test - intact skin
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- Open test - intact skin
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- Open test - intact skin
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Open test - intact skin
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- Open test - intact skin
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- Open test - intact skin
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- Open test - intact skin
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- Open test - intact skin
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Open test - abraded skin
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Open test - abraded skin
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Open test - abraded skin
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- Open test - abraded skin
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- Open test - abraded skin
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- Open test - abraded skin
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Open test - abraded skin
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- Open test - abraded skin
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- Open test - abraded skin
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- Open test - abraded skin
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- Open test - abraded skin
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- Open test - abraded skin
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not specified
Any other information on results incl. tables
ER = erythema; ED = oedema
Open test - abraded skin
| 4 h | 28 h | 52 h | 76 h | |
| Rabbit no. | ER-ED |
ER-ED |
ER-ED |
ER-ED |
| 3418 | 2-1 | 2-1 | 2-2 | 2-1 |
| 3419 | 2-0 | 1-1 | 4-1 | 1-0 |
| 3420 | 1-0 | 1-0 | 4-1 | 1-1 |
| 3421 | 1-0 | 1-1 | 1-1 | 1-1 |
| 3422 | 2-0 | 1-0 | 4-0 | 1-0 |
| 3423 | 1-0 | 2-1 | 2-2 | 4-1 |
| average | 1.7 | 2.0 | 4.0 | 2.3 |
Open test - intact skin
| 4 h | 28 h | 52 h | 76 h | |
| Rabbit no. | ER-ED |
ER-ED |
ER-ED |
ER-ED |
3418 |
2-0 |
2-1 |
2-2 |
2-1 |
3419 |
1-0 |
1-0 |
1-1 |
1-1 |
| 3420 | 1-0 | 1-0 | 2-1 | 1-1 |
| 3421 | 2-0 | 1-1 | 1-1 | 1-0 |
| 3422 | 1-0 | 1-0 | 1-0 | 1-1 |
| 3423 | 1-0 | 1-1 | 3-1 | 4-1 |
| average | 1.3 | 1.7 | 2.7 | 2.5 |
Closed patch test - abraded skin
| 4 h | 28 h | 52 h | 76 h | |
| Rabbit no. | ER-ED |
ER-ED |
ER-ED |
ER-ED |
| 3418 | 4-1 | 4-1 | 4-2 | 2-1 |
| 3419 | 4-2 | 4-2 | 4-2 | 4-2 |
| 3420 | 4-1 | 4-2 | 4-2 | 4-1 |
| 3421 | 4-1 | 4-2 | 4-2 | 4-2 |
| 3422 | 2-1 | 2-1 | 2-1 | 2-1 |
| 3423 | 1-1 | 2-1 | 3-2 | 4-1 |
| 4.3 | 4.8 | 5.3 | 4.7 |
Closed patch test - intact skin
| 4 h | 28 h | 52 h | 76 h | |
| Rabbit no. | ER-ED |
ER-ED |
ER-ED |
ER-ED |
| 3418 | 1-0 | 4-1 | 4-2 | 2-1 |
| 3419 | 1-1 | 2-1 | 2-2 | 2-1 |
| 3420 | 4-1 | 4-1 | 4-1 | 1-1 |
| 3421 | 1-1 | 2-1 | 3-2 | 4-2 |
| 3422 | 1-1 | 2-1 | 2-1 | 2-1 |
| 3423 | 1-1 | 2-1 | 3-2 | 4-1 |
| average | 2.3 | 3.7 | 4.7 | 3.7 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- On the basis of the results obtained and the primary irritation indices calculated it is concluded that the undiluted test substance is a moderate primary skin irritant, both in case of 4 hours contact with the open, non-occluded, rabbit skin and in the case of 4 hours contact with the occluded rabbit skin.
Furthermore, it appeared that the test substance caused more severe irritation of the skin in the closed patch test than in the open test. - Executive summary:
The test substance was examined undiluted for primary skin irritation properties in a 4 -hour open test and in a 4 -hour closed patch test with six albino rabbits.
The dermal effects generally observed in both tests consisted of very slight or well-defined erytheme, very slight or slight oedema, very slight or slight incrustation, and slight or slight to moderate scaliness.
In addition, slight haemorraghes were obsrebed in the closed patch test. The dermal effects observed in the closed patch test were more severe than those observed in the open test.
The primary irritation indices were calculated to be 2.4 (open test) and 4.2 (closed patch test).
On the basis of the results obtained and the primary irritation indices calculated it was concluded that the undiluted test substance is a moderate primary skin irritant, both in case of 4 hours contact with the open, non-occluded, rabbit skin and in the case of 4 hours contact with the occluded rabbit skin.
Furthermore, it appeared that the test substance caused more severe irritation of the skin in the closed patch test than in the open test.
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