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Toxicological information

Repeated dose toxicity: dermal

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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:
read-across: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
Deviations:
yes
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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.