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EC number: 288-213-7 | CAS number: 85681-75-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- In vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981-06-25 to 1981-07-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it was conducted according to OECD 405 guidelines and was GLP compliant.
- 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, other
- Remarks:
- In vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1981-06-25 to 1981-07-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it was conducted according to OECD 405 guidelines and was GLP compliant.
- 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ray Nichols Rabbitry
- Weight at study initiation: 2.3 kilograms to 3.4 kilograms
- Housing: Individual
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 25 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.8 to 22.2 °C
- Humidity (%): 30 to 70%
IN-LIFE DATES: From: 25 June 1981 To: 29 July 1981 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 millilitre
- Concentration (if solution): Undiluted (100%) - Duration of treatment / exposure:
- Rabbits in the "washed" group had eyes flushed 30 seconds after exposure; rabbits in the "unwashed" group did not have eyes flushed.
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- Nine total, three males in the "washed" group, three males and three females in the "unwashed" group
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): In three males using tap water
- Time after start of exposure: 30 seconds
SCORING SYSTEM: Draize - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- 0.22
- Irritation parameter:
- conjunctivae score
- Remarks:
- Oedema
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- 0.11
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 5.3
- Max. score:
- 110
- Remarks on result:
- other: Washed eyes
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 5
- Max. score:
- 110
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hour
- Score:
- 4
- Max. score:
- 110
- Remarks on result:
- other: Washed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hour
- Score:
- 1.3
- Max. score:
- 110
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 hour
- Score:
- 1.3
- Max. score:
- 110
- Remarks on result:
- other: Washed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 hour
- Score:
- 0.67
- Max. score:
- 110
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hour
- Score:
- 2
- Max. score:
- 110
- Remarks on result:
- other: Washed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hour
- Score:
- 0.67
- Max. score:
- 110
- Remarks on result:
- other: Unwashed eyes
- Irritant / corrosive response data:
- The maximum mean total irritation score at 1 hour post-exposure was 5.0 out of 110 for unwashed eyes and 5.3 out of 110 for washed eyes. There was no significant difference in irritation scores between washed and unwashed eyes. No irritation effects were seen 8 days post-exposure; all effects were fully reversible.
- Other effects:
- None reported
- Interpretation of results:
- other: Not irritating according to EU CLP classification
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- 1-hexene is not classified as an eye irritant according to EU CLP, based on the study results. There was no significant difference in irritation scores between washed and unwashed eyes and all effects were fully reversible within 8 days.
- Executive summary:
In a primary eye irritation study, 0.1 millilitre of 1-hexene, undiluted, was instilled into the conjunctival sac of the right eyes of six male and three female New Zealand White rabbits. Three males had their eyes washed 30 seconds post-exposure. Animals were then observed for 8 days. Irritation was scored by the method of Draize.
Mild irritation was noted 1 hour post-exposure in both washed and unwashed eyes. Irritation persisted to day 3 of the observation period, but was not noted on day 8 post-exposure. In this study, Neodene 6 is not classified as an eye irritant based on OECD GHS.
This study received a Klimisch score of 1 and is classified as reliable without restriction because it was conducted according to OECD 405 guidelines and was GLP compliant.
According to the final classification system provided by the report, 1 -hexene is classified as "mildly irritating" to the rabbit eye based on the maximum mean total irritation scores at the 1-hour observation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hex-1-ene
- EC Number:
- 209-753-1
- EC Name:
- Hex-1-ene
- Cas Number:
- 592-41-6
- Molecular formula:
- C6H12
- IUPAC Name:
- hex-1-ene
- Details on test material:
- - Name of test material (as cited in study report): Neodene 6
- Substance type: C6 alpha olefin
- Physical state: Liquid
- Stability under test conditions: Stable
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ray Nichols Rabbitry
- Weight at study initiation: 2.3 kilograms to 3.4 kilograms
- Housing: Individual
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 25 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.8 to 22.2 °C
- Humidity (%): 30 to 70%
IN-LIFE DATES: From: 25 June 1981 To: 29 July 1981
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 millilitre
- Concentration (if solution): Undiluted (100%) - Duration of treatment / exposure:
- Rabbits in the "washed" group had eyes flushed 30 seconds after exposure; rabbits in the "unwashed" group did not have eyes flushed.
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- Nine total, three males in the "washed" group, three males and three females in the "unwashed" group
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): In three males using tap water
- Time after start of exposure: 30 seconds
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- 0.22
- Irritation parameter:
- conjunctivae score
- Remarks:
- Oedema
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- 0.11
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 5.3
- Max. score:
- 110
- Remarks on result:
- other: Washed eyes
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 5
- Max. score:
- 110
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hour
- Score:
- 4
- Max. score:
- 110
- Remarks on result:
- other: Washed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hour
- Score:
- 1.3
- Max. score:
- 110
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 hour
- Score:
- 1.3
- Max. score:
- 110
- Remarks on result:
- other: Washed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 hour
- Score:
- 0.67
- Max. score:
- 110
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hour
- Score:
- 2
- Max. score:
- 110
- Remarks on result:
- other: Washed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hour
- Score:
- 0.67
- Max. score:
- 110
- Remarks on result:
- other: Unwashed eyes
- Irritant / corrosive response data:
- The maximum mean total irritation score at 1 hour post-exposure was 5.0 out of 110 for unwashed eyes and 5.3 out of 110 for washed eyes. There was no significant difference in irritation scores between washed and unwashed eyes. No irritation effects were seen 8 days post-exposure; all effects were fully reversible.
- Other effects:
- None reported
Any other information on results incl. tables
According to the final classification system provided by the report, 1 -hexene is classified as "mildly irritating" to the rabbit eye based on the maximum mean total irritation scores at the 1-hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating according to EU CLP classification
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- 1-hexene is not classified as an eye irritant according to EU CLP, based on the study results. There was no significant difference in irritation scores between washed and unwashed eyes and all effects were fully reversible within 8 days.
- Executive summary:
In a primary eye irritation study, 0.1 millilitre of 1-hexene, undiluted, was instilled into the conjunctival sac of the right eyes of six male and three female New Zealand White rabbits. Three males had their eyes washed 30 seconds post-exposure. Animals were then observed for 8 days. Irritation was scored by the method of Draize.
Mild irritation was noted 1 hour post-exposure in both washed and unwashed eyes. Irritation persisted to day 3 of the observation period, but was not noted on day 8 post-exposure. In this study, Neodene 6 is not classified as an eye irritant based on OECD GHS.
This study received a Klimisch score of 1 and is classified as reliable without restriction because it was conducted according to OECD 405 guidelines and was GLP compliant.
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.
