3-methyl-5-phenylpentanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1987-06-02 to 1987-06-16

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted in accordance with the standardised guidelines OECD 404 and EU Method B.4 and performed in line with GLP with a sufficient level of detail to assess the quality of the presented data. The study was performed on a similar substance to 3-methyl-5-phenylpentanol; the test substance in this study is the aldehyde of 3-methyl-5-phenylpentanol and as such is considered to be sufficient for read-across to address the endpoint.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

55066-49-4

EC Number:

611-227-5

Cas Number:

55066-49-4

IUPAC Name:

55066-49-4

Constituent 2

Reference substance name:

-

EC Number:

433-900-0

EC Name:

-

IUPAC Name:

433-900-0

Constituent 3

Reference substance name:

3-methyl-5-phenylpentan-1-al

IUPAC Name:

3-methyl-5-phenylpentan-1-al

Test material form:

other: liquid (not specified)

Details on test material:

- Physical state: Liquid, clear, colourless

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: ENKI-Konjnegarm, Someren, The Netherlands
- Weight at study initiation: 2500-3500 g
- Housing: Housed individually in suspended galvanized cages, fitted with wire-mesh floor and front
- Diet: standard laboratory diet ad libitum
- Water: tap water ad libitum
- Acclimation period: At least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): at least 40 %
- Air changes (per hr): ca. 10 changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied : 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Intact skin on the back and flanks under a 1 x 1 inch patch
- Type of wrap if used: The patches were fixed to the exposure site by adhesive tape and the entire trunk of each rabbit was wrapped with an impervious material.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize et al (1944)
A. ERYTHEMA AND ESCHAR FORMATION
No erythema - 0
Very slight erythema (barely perceptible) - 1
Well-defined erythema - 2
Moderate to severe erythema - 3
Severe erythema (beet redness); eschar formation (injuries in depth) - 4

B. OEDEMA FORMATION
No oedema - 0
Very slight oedema (barely perceptible) - 1
Slight oedema (edges of area well-defined by definite raising) - 2
Moderate oedema (raised approximately 1 mm) - 3
Severe oedema (raised more than 1 mm, extending beyond the area of exposure) - 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 hour

Score:

3.3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1 hour

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 hours

Score:

2.7

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 hours

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 7

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 hours

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

The following effects were noted between 1 and 72 hours post patch removal:
Very slight, well-defined and moderate erythema; very slight or slight oedema; very slight ischemia; slight scaliness. During the course of the observation period, these effects cleared gradually. After 7 days, well-defined erythema and very slight oedema were observed. After 14 days, all irritation had cleared completely.

Any other information on results incl. tables

Table 1: Results

 

Animal No.	Observation	Hours after removal
		1	24	48	72
4486	Erythema	2	3	3	3
	Oedema	1	1	1	1
4487	Erythema	4	2	1	1
	Oedema	1	1	1	1
4388	Erythema	4	3	2	2
	Oedema	2	1	1	1
Average	Erythema	3.3	2.7	2.0	2.0
	Oedema	1.3	1.0	1.0	1.0

Erythema observations included ischemia, haemorrhages and incrustation

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test, the test substance was found to be irritating, but not corrosive, to rabbit skin when applied undiltuted for four hours under occlusion.

Executive summary:

The skin irritation and corrosion potential of the test substance was examined in vivo, in accordance with GLP and performed in line with the standardised guidelines OECD 404 and EU Method B.4. The study was performed on the aldehyde of 3-methyl-5-phenylpentanol, which is very similar both in structure and toxicological, ecotoxicological and physicochemical properties. The results of this study are therefore considered to be a good reflection of the properties of 3-methyl-5-phenylpentanol. Under the conditions of the test, irritation was noted in all animals which persisted past seven days. All effects were fully reversed by day 14. Under the conditions of the test, the test substance was found to be irritating, but not corrosive, to rabbit skin when applied undiluted for four hours under occlusion.