Registration Dossier
Registration Dossier
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EC number: 203-425-1 | CAS number: 106-70-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 Apr - 29 Apr 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
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)
- Version / remarks:
- adopted in 1981
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl hexanoate
- EC Number:
- 203-425-1
- EC Name:
- Methyl hexanoate
- Cas Number:
- 106-70-7
- Molecular formula:
- C7H14O2
- IUPAC Name:
- methyl hexanoate
- Details on test material:
- - Name of test material (as cited in study report): methyl hexanoate
- Substance type: Fatty acid methyl ester
- Physical state: liquid, colourless
- Analytical purity: > 98%
- Lot/batch No.: 1291191
- Expiration date of the lot/batch: 24.06.1994
- Storage condition of test material: room temperature
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 GmbH, Biberach, Germany
- Age at study initiation: approx. 15 months
- Weight at study initiation: approx. 2540 g
- Housing: individually
- Diet (e.g. ad libitum): Ssniff rabbit diet K4 (Ssniff GmbHm Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 70
- Air changes (per hr): 8
- 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 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 22 days
Reading time points: 1, 24, 48, 72 h, day 7, day 14 and day 22 - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal skin, 6 cm²
- Type of wrap if used: adhesive air- and vapour permeable semiocclusive dressing (gauze patch fixed with a hypoallergenic adhesive gauze-bandage)
REMOVAL OF TEST SUBSTANCE
The skin was cleaned from residual test substance after removal of the dressing.
SCORING SYSTEM
The Draize scoring system was used.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 22 days
- Remarks on result:
- other: At the end of observation period on day 22 slight erythema graded 1 still was seen
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: transient eschar formation was noticed on day 7
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 22 days
- Remarks on result:
- other: at the end of observation period on day 22 slight edema graded 1 still was observed
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Slight to weak erythema and edema were observed in all three animals from reading time point 1 h to 72 h. One animal displayed transient eschar on day 7. In two cases, full reversibility was achieved with 14 days whereas in the third animal slight erythema and edema graded 1, respectively, still were evident at the end of the observation period of 22 days.
Any other information on results incl. tables
Table 1: Individual evaluation of skin findings for each of the 3 rabbits used:
Animal |
Hours after application |
|||||||
1 |
24 |
48 |
72 |
|||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 |
1 |
0 |
2 |
1 |
2 |
1 |
1 |
1 |
2 |
1 |
0 |
1 |
1 |
2 |
1 |
2 |
1 |
3 |
2 |
2 |
2 |
2 |
2 |
1 |
1 |
1 |
Animal |
Days after application |
|
||||
7 |
14 |
22 |
||||
Reversibility |
Erythema |
Edema |
||||
1 |
not reversible |
not reversible |
no |
1 |
1 |
|
2 |
not reversible |
reversibility achieved |
yes |
0 |
0 |
|
3 |
not reversible (transient eschar) |
reversibility achieved |
yes |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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