Octene, hydroformylation products, high-boiling

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline Study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(adopted 24 April 2002)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Safepharm Laboratories Limited, Shardlow, Derbyshire, UK

Test material

Test material information

Constituent 1

Reference substance name:

Octene, hydroformylation products, high-boiling

EC Number:

271-237-7

EC Name:

Octene, hydroformylation products, high-boiling

Cas Number:

68526-89-6

Molecular formula:

Unspecified

IUPAC Name:

Reaction products of octene, hydroformylation products of C8-alkenes, high boiling

Details on test material:

- Name of test material (as cited in study report): Oxooil HS9
- Physical state: pale yellow liquid
- Analytical purity: not stated
- Storage condition of test material: Room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK
- Age at study initiation: twelve to twenty weeks
- Weight at study initiation: 2 - 3.5 kg
- Housing: individually
- Diet: Free access to food (Certified Rabbit Diet)
- Water: Free access to drinking water
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

3 min, 1 h and 4 h

Observation period:

one hour following the removal of the patches, 24, 48 and 72 hours later; additional observations were made on Days 7 and 14;

Number of animals:

- 3 min and 1 h: 1 rabbit;
- 4 h: 3 rabbits

Details on study design:

TEST SITE
- Area of exposure: dorsal/flank area (one animal), back (two animals)
- Type of wrap if used: The test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 3 minutes, 1 hour and 4 hours after application

SCORING SYSTEM: according to OECD 404 / Draize J. H. (1959) "Dermal Toxicity" In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of the United States, Austin, Texas, p.46-59

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(animal 1 - 3)

Time point:

other: 24 - 48 - 72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: see table below for details

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

(animal 1-3)

Time point:

other: 24 - 48 - 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: edema (score 1) only detected in one animal; see table below for details

Irritant / corrosive response data:

- 3-Minute Exposure Period:
Very slight erythema was noted at the treated skin site at the 24-hour observation, with well defined erythema and very slight oedema at the 48-hour observation. Very slight erythema, very slight oedema and loss of skin elasticity were noted at the 72-hour observation

- 1-Hour Exposure Period:
Very slight erythema was noted at the treated skin site one hour after patch removal and at the 24-hour observation, with well defined erythema and very slight oedema at the 48-hour observation. Very slight erythema, very slight oedema and loss of skin elasticity were noted at the 72-hour observation. Slight desquamation was noted at the 7-day observation.

- 4-Hour Exposure Period:
Very slight erythema was noted at one treated skin site one hour after dressing removal. Very slight to well defined erythema was noted at all treated test sites at the 24-hour, 48-hour and 72-hour observations. Very slight oedema was noted at one treated skin site one hour after dressing removal and at the 24-hour, 48-hour and 72-hour observations. Loss of skin elasticity was noted at two treated skin sites at the 48-hour observation and at all
treated skin sites at the 72-hour observation, with loss of flexibility at one treated skin site. Crust formation was noted at one treated skin site, with slight desquamation at one other treated skin site at the 7-day observation. One treated skin site appeared normal at the 7-day observation, and one treated skin site appeared normal at the 14-day observation.

Any other information on results incl. tables

Exposition:	3 min
Animal	Reading	Erythema	Edema	Symptoms
1	1 h	0	0
1	24 h	1	0
1	48 h	2	1
1	72 h	1	1	loss of skin elasticity
1	7 d	0	0
1	14 d	0	0
mean	24 - 72 h	1.30	0.70
Exposition:	1 h
Animal	Reading	Erythema	Edema	Symptoms
1	1 h	1	0
1	24 h	1	0
1	48 h	2	1
1	72 h	1	1	loss of skin elasticity
1	7 d	0	0	slight desquamation
1	14 d	0	0
mean	24 - 72 h	1.30	0.70

Exposition:	4 h
Animal	Reading	Erythema	Edema
1	1 h	1	1
2	1 h	0	0
3	1 h	0	0
1	24 h	2	1
2	24 h	1	0
3	24 h	1	0
1	48 h	2	1
2	48 h	1	0
3	48 h	1	0
1	72 h	2	1
2	72 h	1	0
3	72 h	1	0
1	7 d	0	0
2	7 d	0	0
3	7 d	0	0
1	14 d	0	0
2	14 d	not required	not required
3	14 d	not required	not required
mean animal 1	24 - 72 h	2	1
mean animal 2	24 - 72 h	1	0
mean animal 3	24 - 72 h	1	0
mean animal 1-3	24 - 72 h	1.30	0.30

Primary irritation index = 1.7

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU