2-methyl-4-phenylpentanol

Endpoint summary

Description of key information

Skin Irritation:
A single semi-occlusive application of Pamplefleur to intact rabbit skin for four hours (according to OECD TG 404) elicited transient, slight dermal irritation: erythema scores were < 1.3 and edemal scores < 0.6, which were all fully reversible within 6 days.
Eye Irritation:
In an OECD TG 405 study, 0.1 ml Pamplefleur, was instilled into the right eye of each of four rabbits. The cornea and iris scores were all zero. The conjunctivae scores were maximum 2.3 in 2/3 animals. In the two other animals this score was maximum 1. These conjuntivae effects were reversible within 7 days in 3/4 animals. the chemosis scores were maximum 1.6 and fully reversible within 7 days. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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.

Qualifier:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

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.

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.

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

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

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

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

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

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.

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 10 June 1988 and 17 June 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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

Qualifier:

according to guideline

Guideline:

other: OECD Guidelines for Testing of Chemicals

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Species: Rabbit
Strain: Albino New Zealand White
Supplier (Source): Camm Research, Wayne, New Jersey
Sex: Male and female
Age at Initiation: Healthy adult animals
No. on Study: Four ( 4 ) (two male and two female)
Method an Justification of Randomizotion: Stratification by sex, body weight and apparent good health.
Acclimation Period: Five (5) days
System of Identification: Cages marked with an animal group number and dose level. Rabbits were ear tagged.

Research Facility Registration: U.S.D.A. Registration No. 23-107 under the Animal Welfare Act 7 4: se 2131 et
Animal Rooms: Separate isolation by test system.
Light cycle - 12 hours light, 12 hours dark.
Temperature/Humidity - Maintained at a temperature of 20°C ± 3°C and a humidity of 30 to 70%.
Housing: Rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
Sanitization: Waste material was removed twice weekly. Cages and feeders were sanitized every two weeks.
Food: Wayne Rabbit Ration, ad libitum, checked daily and added or replaced as needed. Feeders are designed to reduce soiling, bridging and scattering.
Food Analysis: There were no contaminants that were reasonably expected to be present in the dietary material known to be capable of interfering with the purpose or conduct of the study.
Water Analysis: Availability - fresh tap water, ad libitum. Water is monitored for contaminants at periodic intervals according to Standard Operating Procedure PH-018.

Vehicle:

unchanged (no vehicle)

Controls:

other: The other eye, which remained untreated, served as a control.

Amount / concentration applied:

0.1 ml/eye

Duration of treatment / exposure:

Up to 1 hour

Observation period (in vivo):

7 Days

Number of animals or in vitro replicates:

4

Details on study design:

Rationale for Test System: A variety of experimental animals have been used, but i t is recommended that testing be performed using healthy adult albino rabbits.
Compound Preparation: Dosed as received.
Rationale for Dose Selection: According to EPA Federal Register, Vol. 50, No. 188, Friday, September 27, 1985, and OECD Guidelines for Testing of Chemicals, adopted: 24 Feb 87.
Dose Administration: 0.1 ml/eye
Vehicle: Not applicable
Route of Administration: The test article was administered directly into the eye.
Rationale for Route of Administration: To evaluate the irritant potential of the test article on the eye.
Frequency and Duration of Administration: Once (1)
No. and description of Animals Per Dose Group: Four (4) (two males and two females)
No. and Code of Dose Group: Rabbit No. 8586-8589, Treatment 0.1 ml/right eye
Length of Study: Seven (7) days
Method of Study Performance: Both eyes of each experimental animal provisionally selected for testing were examined within 24 hours prior to testing by the same procedure used during the test examination. Animals showing eye irritation, ocular defects o r pre-existing corneal injury were not
used. The test substance was placed in the conjunctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball.
The lids were then gently held together for about one second in order to limit loss of the material. The other eye, which remained untreated, served as a control.
Type and Frequency of Test, Analysis, and Measurements to be Made: The eyes were examined at 1, 24, 48 and 72 hours and on Day 7 after treatment. The grades of ocular reaction were recorded at each examination.

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Remarks:

animal: 8586 male

Time point:

other: 24, 48 and 72 hours

Score:

2.3

Max. score:

3

Reversibility:

not fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Remarks:

animal: 8587 male

Time point:

other: 24, 48 and 72 hours

Score:

0.6

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Remarks:

animal: 8588 female

Time point:

other: 24, 48 and 72 hours

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Remarks:

animal: 8589 female

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal: 8586 male

Time point:

other: 24, 48 and 72 hours

Score:

1.6

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal: 8587 male

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal: 8588 female

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal: 8589 female

Time point:

other: 24, 48 and 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal: 8586 male

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: No effect noted

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal: 8587 male

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: No effect noted

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal: 8588 female

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: No effect noted

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal: 8589 female

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: No effect noted

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal: 8586 male

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

other: no effect noted

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal: 8587 male

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

other: no effect noted

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal: 8588 female

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

other: no effect noted

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal: 8589 female

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

other: no effect noted

Irritant / corrosive response data:

Positive ocular scores were recorded at the 1, 24, 48 and 72 hour observation periods. No positive scores were observed on Day 7 and the study was terminated at the sponsor's request.

The pH of the test article was not presented. In view of the chemical structure no strong reactivity is expected (e.g. absence of acidic or basic groups).

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Remarks:

Migrated information

Conclusions:

In an OECD TG 405 test and using CLP criteria it is an eye irritant, while using the DSD criteria the substance is not an eye irritant.

Executive summary:

In an OECD TG 405 study, 0.1 ml Pamplefleur, was instilled into the right eye of each of four rabbits. The cornea and iris scores were all zero. The conjunctivae scores were maximum 2.3 in 2/3 animals. In the two other animals this score was maximum 1. These conjuntivae effects were reversible within 7 days in 3/4 animals. the chemosis scores were maximum 1.6 and fully reversible within 7 days.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
One OECD TG 404 guideline study under GLP was available with a Klimisch reliability of 1.

Justification for selection of eye irritation endpoint:
One OECD TG 405 guideline study under GLP was available with a Klimisch reliability of 1.

Effects on eye irritation: irritating

Justification for classification or non-classification

Skin irritation

In an OECD 404 test transient, slight dermal irritation, which do not warrant classification according to the CLP Regulation (EC) No. 1272/2008 and to DSD 67/548/EC.

Eye irritation:

In an OECD 405 test effects are seen on conjunctivae and chemosis. Pamplefleur is not listed on Annex I of the DSD 67/548/EC (Index no. 603 -092 -00 -6) as an eye irritant. Under DSD 67/548/EC the substance does not fulfil the criteria as an eye irritant. However, under de CLP regulation EC 1272/2008 the substance should be classified as H319 (eye irritant 2), because conjunctival redness was seen at a score > 2 (2.3) in 2/3 animals.