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EC number: 203-966-3 | CAS number: 112-39-0
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:
- 1 992
- 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
- 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
Constituent 1
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
Resultsopen allclose all
- 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
- 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
- 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
- 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
- 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
- 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
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