2-methyl-4-phenylpentanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 11 June 1987 and 25 June 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:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pamplefleur

IUPAC Name:

Pamplefleur

Test material form:

other: liquid

Details on test material:

Label: IFF Study 87-210
Storage: The test article was stored at ambient room temperature and humidity.
Test Article Description: Clear Liquid
Specific Gravity: 0.99
Sample Preparation: Used as received

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Following a quarantine period of at least one week, five healthy male and five healthy female New Zealand Albino rabbits were randomly selected using a computer program of statistics, which generated random numbers. The animals were received from Clifford Roedel on 5/15/87.
The pretest weight range was 2.4 - 2.9 kg for males and 2. 4 - 2.6 kg for females.
The animals were identified by cage notation and a uniquely numbered metal eartag.
The animals were housed 1/cage in suspended wire mesh cages. Bedding was placed beneath the cages. Fresh Purina Rabbit Chow ( Diet #5321) and water were freely available.
The animal room, reserved exclusively for rabbits on acute tests had a 12 hour light/dark cycle and was kept clean and vermin free. The temperature range was 19° to 24°C. The relative humidity ranged from 40 to 85%.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Approximately 24 hours prior to application of the test article, the dorsal area of each animal was clipped free of hair. The prepared site was approximately 10% of the body surface and remained intact.
The test article was applied to the prepared dermal site, one time, by syringe type applicator on a g/kg basis.

Duration of exposure:

24 hours

Doses:

2 g/kg body weight

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

EXPERIMENTAL DESIGN
The test article was applied to the prepared dermal site, one time, by syringe type applicator on a. g/kg basis. For liquid materials, the dose was based on the sample weight as calculated from the specific gravity. For solid materials, the dose was based on the dry weight of the test article and was slightly moistened with water prior to application. The test article was covered with a gauze patch and gentle pressure was applied to the gauze to aid the distribution of the test article over the prepared site. The torso was wrapped with plastic which was secured with nonirritating tape. At 24 hours, the patches were removed and site was washed gently with water or an appropriate solvent, if necessary. The dose schedule follows:
GROUP Dose, g/kg
Test Article 2.0

TYPE AND FREQUENCY 0F OBSERVATIONS
In Vivo
The test sites were scored for dermal irritation at 24 hours post dose and on days 7 and 14 using the numerical Draize scale.
Additional signs were described.
If necessary to evaluate reversibility, observations were extended.
The animals were observed 1, 2 and 4 hours post dose and twice daily for 14 days for mortality, toxicity and pharmacological effects.
Body weights were recorded pretest, weekly, at death and at termination.

Post Mortem
All animals were examined for gross pathology. Abnormal tissues were preserved in 10% buffered formalin for possible future microscopic examination.


EVALUATION OF SKIN REACTIONS
Erythema and Eschar Formation Value

No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Edema Formation

No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well-defined by definite raising) 2
Moderate edema (raised approximately 1 millimetre) 3
Severe edema (raised more than 1 millimetre and extending beyond the area of exposure) 4

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 95% confidence limits not reported.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: Physical signs of diarrhea, yellow nasal discharge, few feces, emaciation, rales and soiling of the anogenital area were noted during the observation period.

Gross pathology:

Necropsy results were normal in 7/10 animals. Gastrointestinal tract abnormalities, brown staining of the anogenital area and emaciation were noted in the remaining animals.

Other findings:

Dermal reactions, absent to slight on days 1 and 7, were absent on day 14.

Applicant's summary and conclusion

Interpretation of results:

other: not considered to be toxic

Remarks:

Criteria used for interpretation of results: other: less than one-half of the animals died at 2.0 g/kg

Conclusions:

The LD50 is greater than 2.0 g/kg of body weight.

Executive summary:

In a study performed according to OECD 402 five healthy male and five healthy female New Zealand Albino rabbits were dosed dermally with Pamplefleur at 2.0 g/kg of body weight. All animals survived the 2.0 g/kg dermal application. Physical signs of diarrhea, yellow nasal discharge, few feces, emaciation, rales and soiling of the anogenital area were noted during the observation period. Body weight changes were normal in 8/10 animals. Two animals lost weight during the study. Dermal reactions, absent to slight on days 1 and 7, were absent on day 14. Necropsy results were normal in 7/10 animals. Gastrointestinal tract abnormalities, brown staining of the anogenital area and emaciation were noted in the remaining animals. The LD 50 is greater than 2.0 g/kg of body weight.