Hexadecene

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable not assignable because this study only examined one dose level, and systemic toxicity was not evaluated.

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:

short-term repeated dose toxicity: dermal

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable not assignable because this study only examined one dose level, and systemic toxicity was not evaluated.

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 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)

Deviations:

yes

GLP compliance:

no

Limit test:

no

Species:

rabbit

Strain:

New Zealand White

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data reported with regard to test animals or environmental conditions.

IN-LIFE DATES: From: not reported To: 28 days later

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on exposure:

No data was reported with regard to area of exposure, percentage of coverage, type of wrap (if used), or time intervals for shavings/clippings.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 millilitres
- Constant volume or concentration used: Yes

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

No data reported.

Frequency of treatment:

5 days a week for 4 weeks for a total of 20 applications

Remarks:

Doses / Concentrations:
0.2 millilitres
Basis:
no data

No. of animals per sex per dose:

Six animals per dose (3 intact and 3 abraded)

Control animals:

no

Details on study design:

No data reported.

Positive control:

None

Observations and examinations performed and frequency:

There were no data reported regarding whether cageside observations or detailed clinical observations were performed. Additionally, there were no data reported with regard to the methods used (if any) for following examinations: body weight, food consumption, food efficiency, water consumption, ophthalmoscopic, haematology, clinical chemistry, urinalysis, and neurobehavioural.
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: 24 hours after each application

Sacrifice and pathology:

Methods for gross pathology or histopathology examinations were not reported.

Statistics:

No data reported.

Clinical signs:

not specified

Dermal irritation:

effects observed, treatment-related

Mortality:

not specified

Body weight and weight changes:

not specified

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Details on results:

OTHER FINDINGS: The study authors reported that animals exposed to 1-octene exhibited questionable hyperaemia, exfoliation, and scab formation.

Dose descriptor:

NOAEL

Sex:

not specified

Basis for effect level:

other: Report only specified dermal irritation and results indicated questionable irritation.

Remarks on result:

not determinable

Remarks:

no NOAEL identified

Critical effects observed:

not specified

The average results for the hyperaemia, exfoliation and scab formation were approximately 2, which fell into the study authors questionable grade. There was no difference in reaction between the abraded and intact animals.

Conclusions:

Using a graded scale of 1 to 6 (none to severe), treatment with 1-octene for 28 days (20 treatments) caused an average score of approximately 2 (considered questionable) for hyperaemia, exfoliation, and scab formation.

Executive summary:

In a 28-day dermal toxicity study, alpha olefin 8 was applied to the shaved skin of six New Zealand white rabbits (3 intact and 3 abraded) at a dose level of 0.2 millilitres for 5 days/week during a 28-day period.

 

The skin was ranked using a graded system by the study authors ranging from 1 (none) to 6 (severe). The average score for hyperaemia, exfoliation, and scab formation was approximately 2 (considered questionable). There were no other toxicity results reported. Therefore, no LOAEL or NOAEL were identified.

 

This study received a Klimisch score of 4 and is classified as not assignable because this study only examined one dose level, and systemic toxicity was not evaluted.

This study was selected as a supporting study because there was only was dose level examined and systemic toxicity was not evaluated; however, the study contains relevant and useful information, allowing this study to qualify as a supporting study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)

Deviations:

yes

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

111-66-0

Molecular formula:

C8H16

Details on test material:

- Name of test material (as cited in study report): Alpha olefin C8
- Substance type: C8 alpha olefin
- Physical state: Liquid
- Other: Density was 0.716 g/mL

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data reported with regard to test animals or environmental conditions.

IN-LIFE DATES: From: not reported To: 28 days later

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on exposure:

No data was reported with regard to area of exposure, percentage of coverage, type of wrap (if used), or time intervals for shavings/clippings.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 millilitres
- Constant volume or concentration used: Yes

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

No data reported.

Frequency of treatment:

5 days a week for 4 weeks for a total of 20 applications

Doses / concentrations

Remarks:

Doses / Concentrations:
0.2 millilitres
Basis:
no data

No. of animals per sex per dose:

Six animals per dose (3 intact and 3 abraded)

Control animals:

no

Details on study design:

No data reported.

Positive control:

None

Examinations

Observations and examinations performed and frequency:

There were no data reported regarding whether cageside observations or detailed clinical observations were performed. Additionally, there were no data reported with regard to the methods used (if any) for following examinations: body weight, food consumption, food efficiency, water consumption, ophthalmoscopic, haematology, clinical chemistry, urinalysis, and neurobehavioural.
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: 24 hours after each application

Sacrifice and pathology:

Methods for gross pathology or histopathology examinations were not reported.

Statistics:

No data reported.

Results and discussion

Results of examinations

Clinical signs:

not specified

Dermal irritation:

effects observed, treatment-related

Mortality:

not specified

Body weight and weight changes:

not specified

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Details on results:

OTHER FINDINGS: The study authors reported that animals exposed to 1-octene exhibited questionable hyperaemia, exfoliation, and scab formation.

Effect levels

Dose descriptor:

NOAEL

Sex:

not specified

Basis for effect level:

other: Report only specified dermal irritation and results indicated questionable irritation.

Remarks on result:

not determinable

Remarks:

no NOAEL identified

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

The average results for the hyperaemia, exfoliation and scab formation were approximately 2, which fell into the study authors questionable grade. There was no difference in reaction between the abraded and intact animals.

Applicant's summary and conclusion

Conclusions:

Using a graded scale of 1 to 6 (none to severe), treatment with 1-octene for 28 days (20 treatments) caused an average score of approximately 2 (considered questionable) for hyperaemia, exfoliation, and scab formation.

Executive summary:

In a 28-day dermal toxicity study, alpha olefin 8 was applied to the shaved skin of six New Zealand white rabbits (3 intact and 3 abraded) at a dose level of 0.2 millilitres for 5 days/week during a 28-day period.

 

The skin was ranked using a graded system by the study authors ranging from 1 (none) to 6 (severe). The average score for hyperaemia, exfoliation, and scab formation was approximately 2 (considered questionable). There were no other toxicity results reported. Therefore, no LOAEL or NOAEL were identified.

 

This study received a Klimisch score of 4 and is classified as not assignable because this study only examined one dose level, and systemic toxicity was not evaluted.

This study was selected as a supporting study because there was only was dose level examined and systemic toxicity was not evaluated; however, the study contains relevant and useful information, allowing this study to qualify as a supporting study.