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EC number: 205-532-9 | CAS number: 142-29-0
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Principles of method if other than guideline:
- BASF test:
0.05 ml of the undiluted test substance was applied to each one eye of two white Vienna rabbits. The test material was not washed out. The two animals were observed for 8 days and eye irritation was observed on working days. Findings were recorded after 24, 48 and 72 hours as well as on day 6 and at the end of the observation period on day 8. Findings were graded as described in OECD test guideline 405. - GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 3.02 and 2.9 kg
- Diet: ad libitum
- Water: ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 ml - Duration of treatment / exposure:
- at least 24 hours, test substance was not washed out
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing done
SCORING SYSTEM:
BASF scheme
cornea score (Tr):
+ corresponds to Draize score 1
+-++ corresponds to Draize score 2
++ corresponds to Draize score 3
+++ corresponds to Draize score 4
iris score:
ciliare injection corresponds to Draize score 1
iritis corresponds to Draize score 2
conjuntivae score
R+ corresponds to Draize score 1
R++ corresponds to Draize score 2
R+++ corresponds to Draize score 3
chemosis score
Ö (+) corresponds to Draize score 1
Ö+ corresponds to Draize score 2
Ö++ corresponds to Draize score 3
Ö+++ corresponds to Draize score 3-4
Readings were performed 24, 48 and 72 hours and 6 and 8 days after the application. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicalbe
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material only led to slight signs of irritation (Grade 1 redness of the conjunctivae in both animals) after 24/48/72 hours. The effects were fully reversible within 6 days. Thus, no classification for eye irritation is necessary.
- Executive summary:
In this study, the eye irrtiaiton potential of cyclohexene was investigated. Briefly, 0.05 ml of the undiluted test substance was applied to each one eye of two white Vienna rabbits. The test material was not washed out. The two animals were observed for 8 days and eye irritation was observed on working days. Findings were recorded after 24, 48 and 72 hours as well as on day 6 and at the end of the observation period on day 8. Findings were graded as described in OECD test guideline 405.
The test material only led to slight signs of irritation (Grade 1 redness of the conjunctivae in both animals) after 24/48/72 hours. The effects were fully reversible within 6 days. Thus, no classification for eye irritation is necessary.
|
Animal 1 |
Animal 2 |
||||||
|
Corn. |
Iris |
Conj. |
Chem. |
Corn. |
Iris |
Conj. |
Chem. |
24 h |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
48 h |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
72 h |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
6/8 d |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean 24, 48 and 72 h |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
- Principles of method if other than guideline:
- BASF test:
0.05 ml of the undiluted test substance was applied to each one eye of two white Vienna rabbits. The test material was not washed out. The two animals were observed for 8 days and eye irritation was observed on working days. Findings were recorded after 24, 48 and 72 hours as well as on day 6 and at the end of the observation period on day 8. Findings were graded as described in OECD test guideline 405. - GLP compliance:
- no
Test material
- Reference substance name:
- Cyclohexene
- EC Number:
- 203-807-8
- EC Name:
- Cyclohexene
- Cas Number:
- 110-83-8
- Molecular formula:
- C6H10
- IUPAC Name:
- cyclohexene
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 3.02 and 2.9 kg
- Diet: ad libitum
- Water: ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 ml - Duration of treatment / exposure:
- at least 24 hours, test substance was not washed out
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing done
SCORING SYSTEM:
BASF scheme
cornea score (Tr):
+ corresponds to Draize score 1
+-++ corresponds to Draize score 2
++ corresponds to Draize score 3
+++ corresponds to Draize score 4
iris score:
ciliare injection corresponds to Draize score 1
iritis corresponds to Draize score 2
conjuntivae score
R+ corresponds to Draize score 1
R++ corresponds to Draize score 2
R+++ corresponds to Draize score 3
chemosis score
Ö (+) corresponds to Draize score 1
Ö+ corresponds to Draize score 2
Ö++ corresponds to Draize score 3
Ö+++ corresponds to Draize score 3-4
Readings were performed 24, 48 and 72 hours and 6 and 8 days after the application.
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
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicalbe
Any other information on results incl. tables
|
Animal 1 |
Animal 2 |
||||||
|
Corn. |
Iris |
Conj. |
Chem. |
Corn. |
Iris |
Conj. |
Chem. |
24 h |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
48 h |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
72 h |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
6/8 d |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean 24, 48 and 72 h |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material only led to slight signs of irritation (Grade 1 redness of the conjunctivae in both animals) after 24/48/72 hours. The effects were fully reversible within 6 days. Thus, no classification for eye irritation is necessary.
- Executive summary:
In this study, the eye irrtiaiton potential of cyclohexene was investigated. Briefly, 0.05 ml of the undiluted test substance was applied to each one eye of two white Vienna rabbits. The test material was not washed out. The two animals were observed for 8 days and eye irritation was observed on working days. Findings were recorded after 24, 48 and 72 hours as well as on day 6 and at the end of the observation period on day 8. Findings were graded as described in OECD test guideline 405.
The test material only led to slight signs of irritation (Grade 1 redness of the conjunctivae in both animals) after 24/48/72 hours. The effects were fully reversible within 6 days. Thus, no classification for eye irritation is necessary.
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.
