[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-11-02 to 1994-11-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified reliable without restriction. The study was conducted according to OECD 404 Guidelines and followed GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Details on test material:

- Substance type: 1-dodecene dimer, hydrogenated
- Physical state: liquid, clear colourless
- Lot/batch No.: C1527-04-2
- Storage condition of test material: Room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Davis Percival Ltd., Cheshire, U.K.
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.23-2.51 Kg
- Housing: Individually in suspended metal cages
- Diet (e.g. ad libitum): Stanrab SQC Rabbit Diet, Special Diets Services Ltd., Essex, U.K. ad libitum
- Water (e.g. ad libitum): Mains drinking water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-20˚C
- Humidity (%): 58-65%
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

IN-LIFE DATES: From: 1994-11-02 To: 1994-11-05

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

6 (4 Female; 2 male)

Details on study design:

TEST SITE
- Area of exposure: orsal/flank area
- % coverage: not reported
- Type of wrap if used: semi-occlusive wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, removed by gentle swabbing with cotton voo lsoaked in 74% Industrial Methylated Spirits
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Remarks on result:

other: No visible oedema observed

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within: 48h

Results 5

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Results 7

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 48h

Irritant / corrosive response data:

Very slight erythema was noted at four treated skin sites thirty minutes after patch removal and persisted at two treated skin sites at the 24- hour observation. Very slight erythema was also noted at the control site of two animals at the 30 minute observation and persisted at one control site at the 24-hour observation. All treated skin sites appeared normal at the 48-hour observation. No corrosive effects were noted and no oedema was observed either.

Any other information on results incl. tables

Rabbit (Sex M/F)	Observation Time (Hours)	Dermal Reactions
		Erythema	Oedema
Female	24	0	0
	48	0	0
	72	0	0
Female	24	0	0
	48	0	0
	72	0	0
Female	24	1	0
	48	0	0
	72	0	0
Female	24	0	0
	48	0	0
	72	0	0
Male	24	0	0
	48	0	0
	72	0	0
Male	24	1	0
	48	0	0
	72	0	0
Total		2	0
Mean		0.1	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The primary irritation index (PII) was determined to be 0.25 and the mean 24, 48, and 72 hour scores for erythema and edema were 0.1 and 0.0, respectively. Based on these results in the rabbit, 1-dodecene dimer, hydrogenated is not considered to be irritating to the rabbit skin. 

Executive summary:

In a primary dermal irritation study (Driscoll, R., 1995; Klimisch score = 1), 6 New Zealand White rabbits/sex were exposed to 0.5 mL of 1-dodecene dimer, hydrogenated under semi-occlusive wrap for a period of 4 hours. Thereafter, the application sites were cleaned by gentle swabbing with cotton wool soaked in 74% Industrial methylated spirits and the rabbits were observed for erythema and edema at 30 minutes, 24, 48, and 72 hours post-exposure. Dermal irritation was scored using the method of Draize.

Very slight erythema was noted at four treated skin sites thirty minutes after patch removal and persisted at two treated skin sites at the 24- hour observation. Very slight erythema was also noted at the control site of two animals at the 30 minute observation and persisted at one control site at the 24-hour observation. All treated skin sites appeared normal at the 48-hour observation. No corrosive effects were noted and no oedema was observed either.

The primary irritation index (PII) was determined to be 0.25 and the mean 24, 48, and 72 hour scores for erythema and edema were 0.1 and 0.0, respectively. Based on these results in the rabbit, 1-dodecene dimer, hydrogenated is not considered to be irritating to the rabbit skin.