Registration Dossier
Registration Dossier
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EC number: 293-106-3 | CAS number: 91051-53-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- April 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP and guideline compliant study. Methyl linoleate (CAS# 112-63-0) was used as a structural analogue read-across substance for skin irritation hazard identification of Fatty acids, safflower-oil, Et esters. It can be expected that methyl linoleate would exert similar characteristics in skin irritation. Upon activity of dermal esterases, methyl linoleate would be cleaved into linoleic acid and methanol, representing sufficient similarity to the metabolites linoleic acid and ethanol, resulting from cleavage of ethyl linoleate.
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:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl linoleate
- EC Number:
- 203-993-0
- EC Name:
- Methyl linoleate
- Cas Number:
- 112-63-0
- IUPAC Name:
- methyl octadeca-9,12-dienoate
- Reference substance name:
- octadecadienoic acid methyl ester
- IUPAC Name:
- octadecadienoic acid methyl ester
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): ocatdecadienoic acid methyl ester
- Physical state: liquid
- Analytical purity: 100%
- Lot/batch No.: 118 F-0083
- Expiration date of the lot/batch: February 1993
- Stability: stable for at least one year, unstable in atmospheric oxygen and light
- Storage condition of test material: cool and dark
Constituent 1
Constituent 2
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. 2600g
- Housing: individual accomodation
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25°C
- Humidity (%): 45 - 70 %
- Air changes (per hr): at least 8 per hour
- Photoperiod (hrs dark / hrs light): 12h dark / 12 h artificial fluorescent light
IN-LIFE DATES: From: 07.04.1992 To: 29.04.1992
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4h
- Observation period:
- 22 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: left flank (6cm²)
- Type of wrap if used: adhesive air- and vapor permeable gauze-patch whihc was fixed by a hapoallergenic adhesive gauze-bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): relevant skin was cleaned from the residual test substance
- Time after start of exposure: 4h
SCORING SYSTEM:
Erythema and eschar formation:
0: no erythema
1: very slight, barely perceptible erythema (slight)
2: well defined erythema (weak)
3: moderate to severe erythema
4: severe erythema (beet redness) to slight eschar formation (injuries in depth)
Edema formation:
0: no edema
1: very slight, barely perceptible edema (slight)
2: slight edema, edges of area well defined (weak)
3: moderate edema, raised approx. 1mm (moderate)
4: severe edema, rasied more than 1mm and extending beyond the area of exposure (severe)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24,48,72h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 22 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24,48,72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 22 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24,48,72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 22 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 22 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24,48,72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- The irritation effects of one experimental animal reversed within 7 days. The skin of this rabbit showed eschar. The observed effects of the other two experimental animals reversed completely within 22 days.
Any other information on results incl. tables
Animal |
Hours after exposure |
Days after exposure |
|||||||||
|
1 |
24 |
48 |
72 |
7 |
14 |
22 |
||||
|
Er |
Ed |
Er |
Ed |
Er |
Ed |
Er |
Ed |
Er |
Ed |
Er |
1 |
1 |
0 |
2 |
2 |
2 |
1 |
2 es |
1 |
I,b, es |
I, es |
+ |
2 |
1 |
0 |
2 |
1 |
3 |
2 b |
3 es |
3 b |
I,b,es |
I |
+ |
3 |
1 |
1 |
1 |
1 |
1 |
2 |
1 es |
1 b |
+ es |
+ |
|
Er = Erythema
Ed = Edema
es = eschar
I = irreversible
b = brownish discoloration
+ = reversible
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the test results the test substance hast to be classified as skin irritant.
- Executive summary:
The undiluted test substance was tested for acute dermal irritation on the dorsal shaved skin of three rabbits in a dose of 0.5 ml. The contact time under semi-occlusive conditions lasted four hours.
Slight to moderate erythema and edema were observed during the first 72 hours after exposure. One week after exposure the skin of all three experimental animals showed eschar. The irritation effects of one experimental animal reversed wihtin 7 days. The skin of this rabbit showed eschar. The observed effects of the other two experimental animals reversed completely within 22 days.
The test substance proved to be moderately irritating to the skin according to the conditions applied.
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