Registration Dossier
Registration Dossier
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EC number: 216-835-0 | CAS number: 1678-91-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-01-14 - 1992-03-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ethylcyclohexane
- EC Number:
- 216-835-0
- EC Name:
- Ethylcyclohexane
- Cas Number:
- 1678-91-7
- Molecular formula:
- C8H16
- IUPAC Name:
- ethylcyclohexane
- Test material form:
- liquid: volatile
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Hra:(NZW)SPF
- Details on test animals or test system and environmental conditions:
- Source: Hazleton Research Laboratories, Denver, PA, USA
No. of Animals: 3
Sex: Not Determined
Body Weight Range at Dosing (grams): 3477 - 3572
Age: Young Adults (At least three months old)
Housing:
All animals were individually housed in suspended, stainless-steel, mesh cages.
Environmental Conditions:
A photoperiod of 12 hours light from 6 a.m. to 6 p.m. Room temperature was maintained at 70-74°F. Relative humidity was maintained at 41-52%.
Diet andWater: ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 mL/animal
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- The hair was removed from an area of the dorsal skin with an electric clipper. A single dose of the material was placed in contact with the sin using a fiber pad and an occlusive wrap to hold the test material in place for four hours. At the end of the exposure period, the application site was rinsed with running water.
The site of application was examined at 1, 24, 48 and 72 hours, and 7 and 14 days after removal of the occlusive patch. Observations included estimation of erythema, edema, necrosis, eschar formation, scarring, erosion, and staining caused by the material as well as general systemic effects.
Animals were weighed at initiation of the study (Day 0), on Day 7, and at termination of the 14-day observation period.No necropsies were conducted at the conclusion of the 14-day observation period.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
Any other information on results incl. tables
Clinical observations graded as described in OECD Guideline 404 (erythema, edema)
ANIMAL NUMBER |
DOSE <mL) |
RESPONSE AT THE SITE OF APPLICATION |
|||||
1HOUR |
24HOURS |
48HOURS |
72HOURS |
7DAYS |
14DAYS |
||
797 |
0.5 |
0,0 |
0,0 |
0,0 |
0,0 |
0,0 |
0,0 |
798 |
0.5 |
0,0 |
0,0 |
0,0 |
0,0 |
0,0 |
0,0 |
799 |
0.5 |
0,0 |
0,0 |
0,0 |
0,0 |
0,0 |
0,0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the lack of an irritant response, the test material was classified as "not irritating to skin".
- Executive summary:
A dose of 0.5 mL of the test material was applied to the skin after the hair was removed with an electric clipper. An occlusive wrap was used to hold the test material against the skin for a period of four hours. No signs of irritation or abnormal clinical signs were observed at any time during the study. All animals survived the 14-day observation period, and all gained weight normally. Based on weight gain and survival rate, there was no evidence of percutaneous absorption.
Based on the lack of an irritant response, the test material was classified as "not irritating to skin".
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