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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it provides no data on GLPs and did not follow Guidelines, but does provide study protocol and results.
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:
direct observations: clinical cases, poisoning incidents and other
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it provides no data on GLPs and did not follow Guidelines, but does provide study protocol and results.
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
Study type:
study with volunteers
Endpoint addressed:
eye irritation
Qualifier:
no guideline available
Principles of method if other than guideline:
This study was conducted in humans, not animals, so there are no applicable regulatory guidelines. The measurement of irritation was subjective, and the objective test examining conjunctival hyperemia is not comparable to animal studies.
GLP compliance:
not specified
Type of population:
general
Subjects:
- Number of subjects exposed: Study 1: 8 subjects (2 men, 6 women); Study 2: 16 subjects (7 men, 9 women)
- Sex: Male and Female
- Age: 25 to 50 years
- Race: Not reported
- Other: Non-smokers
Ethical approval:
confirmed and informed consent free of coercion received
Route of exposure:
ocular
Reason of exposure:
intentional
Details on exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0, 1307, 2266, or 3922 parts per million in air
- 2 exposures separated by a 5 minute non-exposure period: Exposure 1: 15 minutes; Exposure 2: 60 minutes. Both exposures repeated once a week for 5 weeks


Results of examinations:
- Other: As the exposure concentration increased, the perceived irritation intensity and conjunctival hyperemia increased. Changes in conjunctival hyperemia were significant at the highest dose of 1-octene, whereas “total irritation” and “average irritation” were significantly correlated to the exposure concentration. Perceived irritation, changes in conjunctival hyperemia, and exposure concentrations were unrelated to cytological changes in the conjunctival fluid samples.
Conclusions:
There are no applicable guidelines to compare to the test conditions in humans.
Executive summary:

Eye irritation in humans (7 male and 9 female) after exposure to 1-octene (at concentrations of 0, 1307, 2266, and 3922 parts per million) was examined in this study, in order to evaluate cytological changes and conjunctival hyperemia. Human volunteers were exposed to 1-octene once a week for 5 weeks, and photos and conjunctival fluid samples were used to assess effects. Overall, as the exposure concentration increased, the perceived irritation intensity and conjunctival hyperemia increased. Changes in conjunctival hyperemia were significant at the highest dose of 1-octene, whereas “total irritation” and “average irritation” were significantly correlated to the exposure concentration. Perceived irritation, changes in conjunctival hyperemia, and exposure concentrations were unrelated to cytological changes in the conjunctival fluid samples.

This study is classified as reliable with restrictions because it provides no data on GLPs and did not follow Guidelines, but does provide study protocol and results.

This study was selected as a supporting study because it received a lower Klimisch score than the selected key study; however, this study contains relevant and useful data, allowing it to qualify as a supporting study.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1998

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
eye irritation
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
This study was conducted in humans, not animals, so there are no applicable regulatory guidelines. The measurement of irritation was subjective, and the objective test examining conjunctival hyperemia is not comparable to animal studies.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1-Octene
- Substance type: C8 alpha olefin

Method

Type of population:
general
Subjects:
- Number of subjects exposed: Study 1: 8 subjects (2 men, 6 women); Study 2: 16 subjects (7 men, 9 women)
- Sex: Male and Female
- Age: 25 to 50 years
- Race: Not reported
- Other: Non-smokers
Ethical approval:
confirmed and informed consent free of coercion received
Route of exposure:
ocular
Reason of exposure:
intentional
Details on exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0, 1307, 2266, or 3922 parts per million in air
- 2 exposures separated by a 5 minute non-exposure period: Exposure 1: 15 minutes; Exposure 2: 60 minutes. Both exposures repeated once a week for 5 weeks


Results and discussion

Results of examinations:
- Other: As the exposure concentration increased, the perceived irritation intensity and conjunctival hyperemia increased. Changes in conjunctival hyperemia were significant at the highest dose of 1-octene, whereas “total irritation” and “average irritation” were significantly correlated to the exposure concentration. Perceived irritation, changes in conjunctival hyperemia, and exposure concentrations were unrelated to cytological changes in the conjunctival fluid samples.

Applicant's summary and conclusion

Conclusions:
There are no applicable guidelines to compare to the test conditions in humans.
Executive summary:

Eye irritation in humans (7 male and 9 female) after exposure to 1-octene (at concentrations of 0, 1307, 2266, and 3922 parts per million) was examined in this study, in order to evaluate cytological changes and conjunctival hyperemia. Human volunteers were exposed to 1-octene once a week for 5 weeks, and photos and conjunctival fluid samples were used to assess effects. Overall, as the exposure concentration increased, the perceived irritation intensity and conjunctival hyperemia increased. Changes in conjunctival hyperemia were significant at the highest dose of 1-octene, whereas “total irritation” and “average irritation” were significantly correlated to the exposure concentration. Perceived irritation, changes in conjunctival hyperemia, and exposure concentrations were unrelated to cytological changes in the conjunctival fluid samples.

This study is classified as reliable with restrictions because it provides no data on GLPs and did not follow Guidelines, but does provide study protocol and results.

This study was selected as a supporting study because it received a lower Klimisch score than the selected key study; however, this study contains relevant and useful data, allowing it to qualify as a supporting study.