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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 406-700-6 | CAS number: 78531-61-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05.03.1990 to 12.03.1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-(trans-4-propylcyclohexyl)acetophenone
- EC Number:
- 406-700-6
- EC Name:
- 4-(trans-4-propylcyclohexyl)acetophenone
- Cas Number:
- 78531-61-0
- Molecular formula:
- Hill formula: C17H24O CAS formula: C17H24O
- IUPAC Name:
- 1-[4-(4-propylcyclohexyl)phenyl]ethan-1-one
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: 16 - 17 weeks
- Weight at study initiation: 3.10 (3.04 - 3.21) kg
- Housing: KK 017 (floor area: 75 x 54.5 = 4087 cm2, height: 38 cm; manufacturer: Hulskamp)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 24
- Humidity (%):41 to 56
- Air changes (per hr): not specified but, air-conditioned room
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 05.03.1990 until 12.0.3.1990
Test system
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.1 g test item, were instilled into the conjunctival sac of the left eye of all animals.
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM:
CORNEA
Opacity: degree of density (area most dense taken for reading)
0 no ulceration or opacity
1 scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 easily discernible translucent area, details of iris slightly obscured
3 nacreous areas, no details of iris visible, size of pupil barely discernible
4 Opaque cornea, iris not discernible through the opacity
IRIS
0 normal
1 markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 no reaction to light, haemorrhage, gross destruction (any or all of these)
CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
0 blood vessels normal
1 some blood vessels definitely hyperaemic (injected)
2 diffuse, crimson colour, individual vessels not easily discernible
3 diffuse beefy red
Chemosis: lids and/or nictitating membrane
0 no swelling
1 any swelling above normal (including nictitating membranes)
2 obvious swelling with partial eversion of lids
3 swelling with lids about half-closed
4 swelling with lids more than half-closed
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 3 days.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the conducted study, the test substance is not regarded as irritant to the eyes.
- Executive summary:
In a primary eye irritation study in accordance with OECD guideline 405 and EU method B.5, 0.1 g of the undiluted test substance was instilled into the conjunctival sac of the right eye of three female New Zealand White rabbits. The eyes were not washed. Animals were then observed for up to 8 days. Irritation was scored by the method of Draize.
Mean score
(24, 48, and 72 hours)
Maximum value
(2d, 48, or 72 hours)Animal No.
1
2
3
1
2
3
Cornea
A
0
0
0.3
0
0
1
B
0
0
1.3
0
0
4
Iris
A
0
0
0
0
0
0
Conjunctivae
A
1.3
0.6
1.3
2
1
2
B
0.3
0
0.6
1
0
2
Discharge
After single instillation of 0.1 g test item, into the conjunctival sac of the left eye, without rinsing, in 1 animal opacity of cornea (score 1) was seen on day 2. Redness and chemosis of conjunctivae were observed in all 3 animals up to day 3 of the study (mean 1.1). The rabbits showed discharge at the first and second reading. No signs of irritation were observed the iris. The untreated eyes were unchanged. Based on the above results the test substance was non-irritating to eyes.
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.
