Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Currently viewing:

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 there are no statements indicating if the study was conducted according to GLPs or other acceptable guidelines
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 there are no statements indicating if the study was conducted according to GLPs or other acceptable guidelines
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.
GLP compliance:
not specified
Type of population:
general
Subjects:
16 human subjects (7 male, 9 female)
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, 6000, 10400, or 18000 mg/m3
- Exposure 1 and 3: 15 minutes each, Exposure 2: 60 minutes. Each person was subjected to 3 exposures once a week for 5 consecutive weeks with 2nd eye of subjects used as a control by exposure to increasing concentrations of carbon dioxide.
Results of examinations:
- Other: The threshold for irritation was exceeded at two of the higest concentrations tested (10,400 and 18,000 mg/m3) during run 2. Additionally, there was a slight increase in perceived eye irritation intensity at the lowest concentration tested (6000 mg/m3).
Conclusions:
The human irritation threshold for 1-octene was only exceeded at 10,400 and at 18,000 mg/m3.

Executive summary:

In a primary eye irritation study 16 human volunteers (7 male; 9 female) were exposed to vapors of 1-octene at concentrations of 0; 6000; 10,400; and 18,000 mg/m3. Each volunteer was subjected to three constant exposures (Runs 1, 2, and 3) once a week for five consecutive weeks with the first and third run lasting 15 minutes and the second run lasting 60 minutes. The untreated eyes of each person were exposed to increasing concentrations of carbon dioxide (runs 1 and 3) or air (run 2) through the exposure period. A visual analog rating scale (VAS) was used to estimate the average percentage of irritation intensity in the exposed subjects.   The authors reported that during run 2, the threshold for irritation was clearly exceeded at the two highest concentrations of 1-octene, whereas at the lower concentration, there was a slight increase in perceived eye irritation intensity. Based on these results, the authors concluded that the threshold for irritation in the exposed human subjects was clearly exceeded at 10,400 and 18,000 mg/m3.  

This study received a Klimisch score of 2 and is classified as reliable with restrictions because there are no statements indicating if the study was conducted according to GLPs or other acceptable guidelines.

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:
1999

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.
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:
16 human subjects (7 male, 9 female)
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, 6000, 10400, or 18000 mg/m3
- Exposure 1 and 3: 15 minutes each, Exposure 2: 60 minutes. Each person was subjected to 3 exposures once a week for 5 consecutive weeks with 2nd eye of subjects used as a control by exposure to increasing concentrations of carbon dioxide.

Results and discussion

Results of examinations:
- Other: The threshold for irritation was exceeded at two of the higest concentrations tested (10,400 and 18,000 mg/m3) during run 2. Additionally, there was a slight increase in perceived eye irritation intensity at the lowest concentration tested (6000 mg/m3).

Applicant's summary and conclusion

Conclusions:
The human irritation threshold for 1-octene was only exceeded at 10,400 and at 18,000 mg/m3.

Executive summary:

In a primary eye irritation study 16 human volunteers (7 male; 9 female) were exposed to vapors of 1-octene at concentrations of 0; 6000; 10,400; and 18,000 mg/m3. Each volunteer was subjected to three constant exposures (Runs 1, 2, and 3) once a week for five consecutive weeks with the first and third run lasting 15 minutes and the second run lasting 60 minutes. The untreated eyes of each person were exposed to increasing concentrations of carbon dioxide (runs 1 and 3) or air (run 2) through the exposure period. A visual analog rating scale (VAS) was used to estimate the average percentage of irritation intensity in the exposed subjects.   The authors reported that during run 2, the threshold for irritation was clearly exceeded at the two highest concentrations of 1-octene, whereas at the lower concentration, there was a slight increase in perceived eye irritation intensity. Based on these results, the authors concluded that the threshold for irritation in the exposed human subjects was clearly exceeded at 10,400 and 18,000 mg/m3.  

This study received a Klimisch score of 2 and is classified as reliable with restrictions because there are no statements indicating if the study was conducted according to GLPs or other acceptable guidelines.

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.