1,1'-Biphenyl, 4-methyl-4'-(3E)-3-penten-1-yl-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003-07-16 to 2003-07-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

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

Test material information

Constituent 1

Reference substance name:

-

EC Number:

473-310-0

EC Name:

-

Cas Number:

478385-88-5

Molecular formula:

C18H20

IUPAC Name:

4-methyl-4'-[(3E)-pent-3-en-1-yl]-1,1'-biphenyl

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: about 15 weeks
- Weight at study initiation: 3.08 kg (3.05 - 3.13 kg)
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 23 °C
- Humidity: 35 - 60 %
- Air changes: not specified
- Photoperiod:12 / 12 hrs dark / hrs light

The room temperature and relative atmospheric humidity in the animal room was transiently outside the target range of 16 to 22 °C and > 40 %. This deviation did not influence the integrity of the study.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

24, 48, 72 hours after removal of patches

Number of animals:

3 female rabbits

Details on study design:

TEST SITE
- Area of exposure: back
- Type of wrap: The patch was fastened to the left side of the animal's back and kept in place by a self-adhesive fabric.

REMOVAL OF TEST SUBSTANCE
- Washing: wiping off dry
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS : The rabbits were examined for skin alterations, behavior, and general condition 1 hour after removal of the patches, after 24, 48, 72 hours, and then daily up to experimental day 8. Body weight was recorded on experimental days 1 and on experimental days 5 and 8.

SCORING SYSTEM: According to Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Clinical findings
After a single application to the intact dorsal skin of rabbits, for a 4 hours period of exposure under semiocclusive conditions, no signs of irritation were observed in the treated areas.
No signs of clinical toxicity were detected.

Other effects:

Mortality
All animals survived the observation period.

Body weight
Body weight development of the treated rabbits was inconspicuous.

Any other information on results incl. tables

Table 1 Individual local findings

Animal No.		Local findings on day
		1	2	3	4	5	6	7	8
1	Erythema	0	0	0	0	0	0	0	0
	Edema	0	0	0	0	0	0		0
2	Erythema	0	0	0	0	0	0	0	0
	Edema	0	0	0	0	0	0	0	0
3	Erythema	0	0	0	0	0	0	0	0
	Edema	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No skin irritating potential could be detected, thus the test material is not considered to be a skin irritant.

Executive summary:

The purpose of this assay was to identify the skin irritation/corrosion potential of the test item when applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. This study should provide a rational basis for risk assessment to the irritating potential of the test item in man.

To test for primary skin irritation, 0.5 g of the test material was mixed with some drops of Aqua pro injectione to ensure good contact with the skin. Afterwards the test material was spread onto 6 cm2 patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. The study was started as an initial test with one animal and followed by the confirmatory test with 2 further animals. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily for a further 7 days.

Under the conditions of the present study no signs of irritation were seen. The evaluation of the mean scores yields zero at all time points investigated.

In conclusion, no skin irritating potential could be detected, thus the test material is not considered a skin irritant.