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Registration Dossier
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EC number: 203-911-3 | CAS number: 111-82-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 07 Apr - 14 Apr 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions; analytical purity of test item was not given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 1992
- Deviations:
- yes
- Remarks:
- analytical purity of test substance not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl laurate
- EC Number:
- 203-911-3
- EC Name:
- Methyl laurate
- Cas Number:
- 111-82-0
- Molecular formula:
- C13H26O2
- IUPAC Name:
- methyl dodecanoate
- Details on test material:
- - Name of test material (as cited in study report): methyl laurate
- Substance type: Fatty acid methyl ester
- Physical state: liquid, colourless
- Analytical purity: not indicated by sponsor, treated as 100% pure
- Storage condition of test material: room temperature, protected from light
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, The Netherlands
- Age at study initiation: 8 weeks
- Weight at study initiation: 1523, 1526 and 1611 g
- Housing: individually in cages with perforated floors
- Diet: approx 100 g/day of standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, The Netherlands) and hay once a week
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes: approx. 15/hour
- 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 h
- Observation period:
- 7 days
Reading time points: 1, 24, 48, 72 hours and 7 days - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: dorsal skin, 6 cm²
- Type of wrap if used: Scotchpak-non-woven patch mounted on micropore taping secured with Coban elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing was done at the end of the 4 hour exposure period by means of a tissue moistened with water and subsequently a dry tissue
SCORING SYSTEM: 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 72h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: scaliness was seen at day 7
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: see above
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: scaling and bald skin at the edges of the application site were seen at day 7
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: see above
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: scaling and bald skin at the edges of the application site were seen at day 7
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: see above
- Irritant / corrosive response data:
- Four hours exposure resulted in well defined or moderate to severe erythema and moderate edema in the treated skin areas of the three rabbits. Both, erythema and edema, had resolved within 7 days after exposure in all animals. However, at the end of the observation period, scaliness was noted in all animals and in addition bald skin at the edges of the application area was noted in two animals.
Any other information on results incl. tables
Table 1: Individual erythema scores at all reading time points:
Animal Number |
1 h |
24 h |
48 h |
72 h |
7 days |
Mean (24, 48 and 72 h) |
1 |
3 |
2 |
2 |
2 |
0 |
2.0 |
2 |
2 |
2 |
2 |
2 |
0 |
2.0 |
3 |
2 |
3 |
2 |
2 |
0 |
2.3 |
Table 2: Individual edema scores at all reading time points:
Animal Number |
1 h |
24 h |
48 h |
72 h |
7 days |
Mean (24, 48 and 72 h) |
1 |
3 |
2 |
1 |
0 |
0 |
1.0 |
2 |
3 |
3 |
2 |
2 |
0 |
2.3 |
3 |
3 |
2 |
1 |
1 |
0 |
1.3 |
Table 3: Additional findings
Animal Number |
Additional skin findings with time points |
||
Erythema at the edges of the application site |
Scaliness |
Bald skin at the edges of the application site |
|
1 |
Yes (48 h and 72 h) |
Yes (day 7) |
No |
2 |
Yes (48 h and 72 h) |
Yes (day 7) |
Yes (day 7) |
3 |
Yes (72 h) |
Yes (day 7) |
Yes (day 7) |
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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