Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 617-638-6 | CAS number: 84868-02-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17-04-1991 to 09-07-1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- OECD 1981
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (1's,4'r)-4'-pentyl-[1,1'-bi(cyclohexane)]-4-one
- EC Number:
- 617-638-6
- Cas Number:
- 84868-02-0
- Molecular formula:
- C17H30O
- IUPAC Name:
- (1's,4'r)-4'-pentyl-[1,1'-bi(cyclohexane)]-4-one
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Iva: NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: 17 - 19 weeks
- Mean weight at study initiation: 3.33 (3.25 - 3.40) kg
- Housing: cages type KK 017 (floor area: 75 x 54.5 = 4087 cm2, height: 38 cm; manufacturer: Hulskamp) on metal grids
- Diet: Altromin Standard Diet TPFV 2113, pellets from an automatic drinking device ad libitum
- Water: acidified, fully demineralized water from an automatic drinking device ad libitum
- Acclimation period: more than 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 43 - 64
- Photoperiod (hrs dark / hrs light): daylight
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- the test material was moistened with aqua pro injectione
- Controls:
- no
- Amount / concentration applied:
- 0.5 g test item
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 animals - 1 male and 2 female
- Details on study design:
- TEST SITE
- Area of exposure: back side
- Type of wrap: polyethylene foil kept in place by a leather sleeve
REMOVAL OF TEST SUBSTANCE
- Washing: wiped off
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1 hour after removal of the patches and afterwards daily for 14 days
SCORING SYSTEM: Draize and OECD 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- left side
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- right side
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- left side
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- right side
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- left side
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- right side
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- left side
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- right side
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- left side
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- right side
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- left side
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- right side
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.97
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritant / corrosive response data:
- Skin alterations:
Single application of 0.5 g test item to the intact dorsal skin of rabbits, after a 4 hour period of exposure under occlusive conditions, led to severe skin irritation. Erythema (score 1 or 2) from day 1 until day 6 of the study was seen. Edema (score 1 - 3) was observed from day 1 up to day 8 of the study. Erythema and edema were followed by necrosis, large scales (as indicated by score 4), and small scales, which are indicative of corrosivity of the test material.
The cumulative mean scores for erythema and edema were:
Day 1 : 1.9
Day 2 : 2.2
Day 3 : 1.8
Though the cumulative scores for erythema and edema for days 1, 2, and 3 were not indicative of serious effects attention must be given to the corrosive effects. - Other effects:
- Signs of systemic toxicity, body weight, mortality:
No signs of systemic toxicity were detected. The body weight development corresponded to that of untreated rabbits of the same age. All rabbits survived the 15 day observation period.
Any other information on results incl. tables
Skin irritation results
Animal No. |
Sex |
back site |
|
Local findings (study day) |
||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
12 |
14 |
15 |
||||
91012 |
male |
left |
Erythema |
2 |
2 |
2 |
2 |
2 |
4 |
4 |
4 |
0 |
0 |
0 |
0 |
0 |
Edema |
2 |
3 |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Others |
|
|
|
|
|
G |
G |
0 |
S |
S |
S |
S |
S |
|||
right |
Erythema |
2 |
2 |
2 |
2 |
2 |
4 |
4 |
4 |
4 |
4 |
4 |
0 |
0 |
||
Edema |
2 |
3 |
3 |
3 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Others |
|
|
|
|
|
G |
G |
G |
G |
G |
G |
S |
S |
|||
91023 |
female |
left |
Erythema |
2 |
2 |
1 |
1 |
1 |
1 |
4 |
4 |
0 |
0 |
0 |
0 |
0 |
Edema |
2 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Others |
|
|
|
|
|
|
G |
G |
S |
S |
S |
S |
S |
|||
right |
Erythema |
2 |
2 |
1 |
1 |
1 |
1 |
4 |
4 |
0 |
0 |
0 |
0 |
0 |
||
Edema |
1 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Others |
|
|
|
|
|
|
G |
0 |
S |
S |
S |
S |
S |
|||
91015 |
female |
left |
Erythema |
2 |
2 |
2 |
2 |
2 |
2 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
Edema |
2 |
3 |
2 |
2 |
2 |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
|||
Others |
|
|
|
|
|
|
N |
N |
N |
N |
N |
GS |
0G |
|||
right |
Erythema |
2 |
2 |
2 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
||
Edema |
2 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
0 |
0 |
0 |
0 |
0 |
|||
Others |
|
|
|
N |
N |
N |
N |
N |
N |
N |
N |
NGS |
GS |
|||
Mean values |
Erythema |
2.0 |
2.0 |
1.7 |
|
|
|
|
|
|
|
|
|
|
||
Edema |
1.8 |
2.3 |
1.8 |
|
|
|
|
|
|
|
|
|
|
|||
Cumulative mean values |
|
1.9 |
2.2 |
1.8 |
|
|
|
|
|
|
|
|
|
|
||
Body weight development
Body weight development in kg |
|||||||||
Administration |
Animal No. |
Sex |
Study day |
Difference |
|||||
1 |
5 |
8 |
11 |
15 |
|||||
Skin |
91012 |
m |
3.40 |
3.45 |
3.55 |
3.55 |
3.66 |
+0.26 |
|
91023 |
f |
3.34 |
3.34 |
3.38 |
3.42 |
3.46 |
+0.12 |
||
91015 |
f |
3.25 |
3.23 |
3.24 |
3.24 |
3.23 |
-0.02 |
||
Mean values |
|
|
3.33 |
3.34 |
3.39 |
3.40 |
3.45 |
+0.12 |
|
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- The test material produced corrosive effects on contaminated skin.
- Executive summary:
The primary skin irritation potential of the test item was investigated by topical application of 0.5 g to skin of the back and sides of each of three young adult New Zealand White rabbits in a OECD 404 study. The duration of treatment was four hours. The scoring of skin reactions was performed 1 hour after removal of the dressing and afterwards daily for 14 days. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion. In the primary skin irritation test slight and well-defined erythema (score 1 or 2) and edema were observed on the first days after application, and were followed by necrosis, large scales, and small scales later on, indicating corrosivity of the test material. Though the cumulative mean scores for erythema and edema for days 1, 2, and 3 were not indicative of serious effects, the test material produced corrosive effects on skin contaminated under conditions comparable to those of this test.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
