2-methyl-4-phenylpentanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 04 August 1987 and 09 August 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with OECD guidelines and in compliance with GLP.

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:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pamplefleur

IUPAC Name:

Pamplefleur

Test material form:

other: colourless liquid

Details on test material:

Sample designation: Pamplefleur
Purity: >99%.
Pamplefleur, a clear colourless liquid, was received on 18 June 1987 and was stored at ambient temperature.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Three New Zealand White strain rabbits in the weight range 1. 9 to 3.1 kg, prior to treatment on Day 1 and approximately 9 to 14 weeks of age were obtained from Buckmasters, Henham, Hertfordshire, England. The rabbits selected for the study were all acclimated to the laboratory environment.
Each animal was identified by a numbered aluminium tag placed through the edge of one ear. This number was unique within the HRC Industrial Toxicology Department throughout the duration of the study.
The rabbits were individually housed in metal caqes with perforated floors in Buildinq R14 Room 3. They had free access to tap water and SDS Standard Rabbit Diet.
Animal room temperature was maintained at approximately 19°C and relative humidity at 30-70%.
Air exchanqe was maintained at approximately 19 air changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light (0700-1900 hours) in each 24 hour period.
All animals were observed daily for signs of ill health or toxic signs.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0. 5 ml aliquot of Pamplefleur

Duration of treatment / exposure:

4 hours

Observation period:

6 days

Number of animals:

3

Details on study design:

Treatment procedure
Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorsa-lumbar region of each rabbit exposing an area of skin approximately 10 cm square.
A 0. 5 ml aliquot of Pamplefleur was applied under a 2. 5 cm square gauze pad to one intact skin site on each animal.
Each treatment site was occluded with "Elastoplast" elastic adhesive dressing for a four hour period. The animals were not restrained during the exposure period and were returned to their cages.
At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed using water to remove any residual test substance.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal: 651 male

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 Days

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal: 652 Female

Time point:

other: 24, 48 and 72 hours

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 6 Days

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal: 653 Female

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 Days

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal: 651 male

Time point:

other: 24, 48 and 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 4 Days

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal: 652 Female

Time point:

other: 24, 48 and 72 hours

Score:

0.6

Max. score:

4

Reversibility:

fully reversible within: 5 Days

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal: 653 Female

Time point:

other: 24, 48 and 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 4 Days

Irritant / corrosive response data:

Very sliqht erythema with very sliqht oedema was observed in all three animals. On Day 3, well-defined erythema with very sliqht oedema was
observed in one animal.
Desquamation of the stratum corneum was seen in two animals on Days 3 to 5 and in one animal on Days 4 and 5.
The skins were normal in all three animals by Day 6.

Any other information on results incl. tables

Table 1                      Dermal reactions elicited by Pamplefleur

 

Rabbit number and Sex	E = Erythema O = Oedema	Day
		1*	2	3	4	5	6
651♂	E	1	1	1D	1D	1D	0
	O	1	0	1	0	0	0
652♀	E	1	1	2	1D	1D	0
	O	0	0	1	1	0	0
653♀	E	1	1	1D	1D	1D	0
	O	1	0	1	0	0	0

 

*          Approximately 60 minutes after removal of the dressing

D         Desquamation of the stratum corneum

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an OECD TG 404 test Pamplefleur elicited transient, slight dermal irritation.

Executive summary:

An in vivo skin irritation study was according to OECD 404 was performed to assess skin irritation potential. A 0.5 ml aliquot of Pamplefleur was applied under a 2.5 cm square gauze pad to one intact skin site on each animal. Very sliqht erythema with very slight oedema was observed in all three animals. On Day 3, well-defined erythema with very slight oedema was observed in one animal. Desquamation of the stratum corneum was seen in two animals on Days 3 to 5 and in one animal on Days 4 and 5. The skins were normal in all three animals by Day 6. A single semi-occlusive application of Pamplefleur to intact rabbit skin for four hours elicited transient, slight dermal irritation, however, this was not enough for skin irritation classification.