Methyl palmitate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 Mar - 07 Apr 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study with acceptable restrictions; analytical purity of test substance not given.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

analytical purity of test material not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl palmitate

EC Number:

203-966-3

EC Name:

Methyl palmitate

Cas Number:

112-39-0

Molecular formula:

C17H34O2

IUPAC Name:

methyl palmitate

Details on test material:

- Name of test material (as cited in study report): Palmitinsäuremethylester (palmitic acid methyl ester)
- Substance type: Fatty acid methyl ester
- Physical state: solid, pasty, white
- Analytical purity: not indicated
- Impurities: vestige of myristic acid and stearic acid
- Expiration date: 11 July 1992
- Stability under test conditions: stable in pure state for at least 2 years, not stable in water, air and against acid
- Storage condition of test material: room temperature, protected from light

Test animals

Species:

rabbit

Strain:

other: Kleinrussen, Chbb:HM

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: approx. 14 months
- Weight at study initiation: approx. 2480 g
- Housing: individual accommodation
- Diet: Ssniff rabbit diet (K4, Sniff GmbH, Soest, Germany; Charge: 770392/02), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: not required, untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 h

Observation period:

21 days
Reading time points: 1, 24, 48 and 72 hours, day 7, 14 and 21

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsal clipped skin (left resp. right flank), 6 cm²
- Type of wrap if used: air- and vapour permeable gauze-patch fixed with hypoallergenic adhesive gauze bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 4 hours

SCORING SYSTEM: According to the criteria for irritancy and corrosiveness on the skin, Off. J. Europ. Commun., L 180/56 (91/325/EEC), i.e. Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

1.66

Max. score:

4

Reversibility:

fully reversible within: 21 d

Remarks on result:

other: eschar formation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 21 d

Remarks on result:

other: slight erythema and eschar persisted until day 21

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 21 d

Remarks on result:

other: eschar formation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

1.66

Max. score:

4

Reversibility:

fully reversible within: 21 d

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

2.66

Max. score:

4

Reversibility:

fully reversible within: 21 d

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 21 d

Other effects:

There were no sytemic effects reported.

Any other information on results incl. tables

Table 1: Individual erythema and edema scores for each of reading time points 1, 24, 48 and 72 h:

Animal Number	1 h (erythema/edema)	24 h  (erythema/edema)	48 h  (erythema/edema)	72 h  (erythema/edema)
1	1/0	2/1	2/1	1/1
2	2/1	3	3/3	3/2 (brownish discoloration)
3	1/0	3	3/2	3/3

 

Table 2: Evaluation of findings for each of reading time points 7,14 and 21 days

Animal Number	day 7	day 14	day 21	day 21 (erythema/edema)
1	irreversible/eschar	irreversible/eschar	reversible	0/0
2	irreversible/eschar	irreversible	irreversible	1/0
3	irreversible/eschar	irreversible/eschar	reversible	0/0

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: Cat. 2, H315
DSD: Xi, R38