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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Eye irritation
Administrative data
- Endpoint:
- eye 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 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- OECD 1981, updated Guideline adopted February 24, 1987
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Iva: NZW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: 17 - 19 weeks
- Mean weight at study initiation: 3.40 (3.25 - 3.49) 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g test item
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 animals - 1 male and 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not performed
SCORING SYSTEM: OECD 405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.55
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: discharge
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 48 hours
- Irritation parameter:
- other: discharge
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- other: discharge
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Ocular alterations:
After single instillation of 0.1 g test item into the conjunctival sac of the left eye, without rinsing, no irritation of the cornea and iris was observed. Examination of the conjunctivae revealed redness (score 1), chemosis in 1 animal (score 1), and discharge (score 1 - 2) at the first reading. Later on no irritation was seen. According to these results the test material is not regarded as an irritant. - Other effects:
- Signs of systemic toxicity, body weight, mortality:
No signs of systemic toxicity were seen. The body weight development corresponded to that of untreated rabbits of the same age. All animals survived the 8 day observation period.
Any other information on results incl. tables
Eye irritation results
|
|
Animal No. |
Sex |
Local findings (study day) |
|||||||
|
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
||
I Cornea |
A |
91003 |
m |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
91015 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
91021 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
B |
91003 |
m |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
91015 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
91021 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
II Iris |
A |
91003 |
m |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
91015 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
91021 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
III Conjunctivae |
A |
91003 |
m |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
91015 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
91021 |
f |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
B |
91003 |
m |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
91015 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
91021 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Discharge |
|
91003 |
m |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
91015 |
f |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
91021 |
f |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Cornea A: rating according to OECD 405, B: rating according to Draize method, Iris A: rating according to OECD 405, Conjunctivae A: redness rating according to OECD 405, B: chemosis rating according to OECD 405
Body weight development
Body weight development in kg |
||||||
Administration |
Animal No. |
Sex |
Study day |
Difference |
||
1 |
5 |
8 |
||||
Eye |
91003 |
m |
3.45 |
3.51 |
3.49 |
+0.04 |
91015 |
f |
3.25 |
3.27 |
3.32 |
+0.07 |
|
91021 |
f |
3.49 |
3.58 |
3.61 |
+0.12 |
|
Mean values |
|
|
3.40 |
3.45 |
3.47 |
+0.07 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the primary eye irritation test no irritation of the cornea and iris was observed. The test item is not considered to be irritative.
- Executive summary:
The primary irritation potential of the test item was investigated by instillation of 0.1 g into conjunctival sac of the left eye of each of three young adult New Zealand White rabbits in an OECD 405 study. The right eye remained untreated and served as control. After instillation the eyelids were closed for about 30 seconds. Rinsing of the eyes was not performed. Scoring of irritation effects was performed daily after application for 8 days. After single instillation of 0.1 g test item into the conjunctival sac of the left eye, without rinsing, no irritation of the cornea and iris was observed. Examination of the conjunctivae revealed redness (score 1), chemosis in 1 animal (score 1), and discharge (score 1 - 2) at the first reading. Later on no irritation was seen. According to these results the test material is not regarded as an irritant. No signs of systemic toxicity were seen. The body weight development corresponded to that of untreated rabbits of the same age. All animals survived the 8 day observation period. The average irritation values for conjunctival redness, conjunctival swelling, iritis and clouding of the cornea were 0 in each case. The test item was thus evaluated as not irritating to the eye. No staining of the cornea, sclera or conjunctivae of the treated eyes by the test item was observed. No corrosion was observed at any of the measuring intervals. Based upon the above results, the test item is considered to not be severely irritating to the eye.
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.
