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Toxicological information

Eye irritation

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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:
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:
read-across source
Qualifier:
equivalent or similar to
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

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.

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. 

 

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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.