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Registration Dossier
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EC number: 227-561-6 | CAS number: 5888-33-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study conducted pre-GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, section 1500.42
- GLP compliance:
- no
- Remarks:
- Study conducted pre-GLP.
Test material
- Reference substance name:
- Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acrylate
- EC Number:
- 227-561-6
- EC Name:
- Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acrylate
- Cas Number:
- 5888-33-5
- Molecular formula:
- C13H20O2
- IUPAC Name:
- (1S,2S,4S)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl prop-2-enoate
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
The animals were housed and fed individually and maintained in accordance with standard laboratory procedure. Water was available at all times.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of each treated animal
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- 72 hours, unrinsed
- Observation period (in vivo):
- 7 days after treatment
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.61
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: re-evaluated according to GHS criteria
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: re-evaluated according to GHS criteria
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.61
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: re-evaluated according to GHS criteria
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Remarks on result:
- other: re-evaluated according to GHS criteria
Any other information on results incl. tables
- Irreversible damage to cornea, iris, conjunctiva 21 days after exposure in at least one animal
- Mean Draize score in 2 of 3 animals:
- Reversible adverse effects on cornea, iris, conjunctiva
- Mean Draize score in 2 of 3 animals:
- Reversible in 21 days
- Reversible in 7 days
Classification of eye irritation studies according GHS-criteria
Substance:Isobornyl acrylate IBA CAS:5888-33-5
Internal No.:LITSU 95-0072
Date/Expert:06-12-18/Am
Animal No. |
Corneal opacity/Hornhauttrübung[Scores]
|
Mean Draize score |
Reversibility [scores] |
Hazard category |
|||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
|
||
1 |
1 |
1 |
1 |
1 |
0 |
n.d. |
|
2 |
1 |
1 |
0 |
0,66 |
0 |
n.d. |
|
3 |
0 |
0 |
0 |
0 |
0 |
n.d. |
|
4 |
1 |
1 |
1 |
1 |
0 |
n.d. |
|
5 |
1 |
1 |
0 |
0,66 |
0 |
n.d. |
|
6 |
1 |
0 |
0 |
0,33 |
0 |
n.d. |
|
|
|
|
|
|
|
|
none |
|
|
|
|
|
|
|
|
Animal No. |
Iritis/Regenbogenhautentzündung[Scores]
|
Mean Draize score |
Reversibility [scores] |
Hazard category |
|||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
|
||
1 |
0 |
0 |
0 |
0 |
0 |
n.d. |
|
2 |
0 |
0 |
0 |
0 |
0 |
n.d. |
|
3 |
0 |
0 |
0 |
0 |
0 |
n.d. |
|
4 |
0 |
0 |
0 |
0 |
0 |
n.d. |
|
5 |
0 |
0 |
0 |
0 |
0 |
n.d. |
|
6 |
0 |
0 |
0 |
0 |
0 |
n.d. |
|
|
|
|
|
|
|
|
none |
|
|
|
|
|
|
|
|
Animal No. |
Conjunctiva redness (erythem) /Bindehautrötung[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
|||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
|
||
1 |
1 |
1 |
1 |
1 |
0 |
n.d. |
|
2 |
1 |
1 |
0 |
0,66 |
0 |
n.d. |
|
3 |
0 |
0 |
0 |
0 |
0 |
n.d. |
|
4 |
1 |
1 |
1 |
1 |
0 |
n.d. |
|
5 |
1 |
1 |
0 |
0,66 |
0 |
n.d. |
|
6 |
1 |
0 |
0 |
0,33 |
0 |
n.d. |
|
|
|
|
|
|
|
|
none |
Animal No. |
Conjunctiva chemosis /Bindehautödem[Scores]
|
Mean Draize score |
Reversibility [scores] |
Hazard category |
|||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
|
||
1 |
0 |
0 |
0 |
0 |
0 |
n.d. |
|
2 |
1 |
0 |
0 |
0,33 |
0 |
n.d. |
|
3 |
0 |
0 |
0 |
0 |
0 |
n.d. |
|
4 |
1 |
1 |
0 |
0,66 |
0 |
n.d. |
|
5 |
1 |
0 |
0 |
0,33 |
0 |
n.d. |
|
6 |
0 |
0 |
0 |
0 |
0 |
n.d. |
|
|
|
|
|
|
|
|
none |
Classification: Hazard Category |
none |
n.d. = no data
Classification Criteria for serious Eye Damage/Eye Irritation
Category 1
corneal opacity≥ 3
iritis ≥ 1,5
Category 2
corneal opacity≥1
iritis≥1
redness≥2
chemosis≥2
Subcategory 2A
Subcategory 2B
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Classification: not irritating
- Executive summary:
In a primary eye irritation study ( according to Code of Federal Regulations, section 1500.42) 0.1 mL undiluted ISOBORNYL ACRYLATE was instilled into the conjunctival sac of the left eye of 6 New Zealand White rabbits for 72 hours (not rinsed). Animals were observed for 7 days. Irritation was scored according to Draize scoring and re-evalutated according OECD-GHS criteria.
In this study, Isobornyl acrylate is not irritating to eyes.
OECD GHS Category: none
EU GHS Category: none
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