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EC number: 222-829-9 | CAS number: 3624-77-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 Oct - 17 Nov 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction products of oleoyl sarcosine with sodium hydroxide
- IUPAC Name:
- Reaction products of oleoyl sarcosine with sodium hydroxide
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
- Details on test material:
- - Name of test material (as cited in study report): Natriumoleoylsarkosinat, R-CO-N(CH3)-CH2-COONa
- Physical state: yellowish, creamlike
- Analytical purity: 100% (conditional on production the product still contains really approx. 5% sodiumoleat)
- Arrival of test item: 2004-09-16
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: LIttle russian, Chbb:HM(SPF)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: DIMEO Schonwalde GmbH, Schonwalde, Germany and stock Chbb:HM from Charles River Deutschland GmbH, Kisslegg, Germany
- Housing: during a pre-period of at least one week and throughout the experiment the rabbits were caged individually in PPO cages (floor area: 2576 cm²) with perforated floor.
- Diet: pelleted complete rabbit diet "Altromin 2123", ad libitum.
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- 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 mg - Duration of treatment / exposure:
- Initial test: 3 min, 1 and 4 h
Confirmatory test: 4 h - Observation period:
- 21 days
Reading time points: 1, 24, 48 and 72 h and 7, 14 and 21 days - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: anterior area of the animal
- Type of wrap if used: the patch was placed on the appropriate anterior test field and secured semi-occlusively with adhesive Gothaplast tape (2.5 cm).
REMOVAL OF TEST SUBSTANCE
- Washing: after the exposure time the patch was removed, the test field was marked and the treated skin was cleaned with mild soap and lukewarm water.
- Time after start of exposure:
Initial test: 3 min, 1 h and 4 h
Confirmatory test: 4 h
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 72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: scales were still apparent
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Immediately after application, the animal used in the preliminary test showed a well defined erythema. 1, 24, 48 and 72 h after application, well defined to moderate to severe erythema were observed in all animals (see Table 1 + 2 under “Any other information on results incl. tables”).
24, 48 and 72 h after application: slight to moderate oedema were observed in all animals. After 1 h slight oedema was observed in one animal.
7 days after application: isolated scales were observed on the anterior left test field of one animal and thick, brown scales on the middle left test field and a thick, brown crust of scales on the whole posterior left test field. The remaining two animals showed large, white scales on the whole anterior left test fields.
14 days after application: scales were observed in two animals whereas no skin reactions were observed for the third animal.
21 days after application: one animal still showed isolated scales. - Other effects:
- No further local or systemic effects were observed.
Any other information on results incl. tables
Table 1. Results of the initial irritation study.
Exposure time |
Erythema formation observed [h] |
Oedema formation observed [h] |
||||||||
0 |
1 |
24 |
48 |
72 |
0 |
1 |
24 |
48 |
72 |
|
3 min |
0 |
0 |
2 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
1 h |
0 |
0 |
3 |
2 |
2 |
0 |
0 |
1 |
1 |
1 |
Table 2. Results of skin irritation study.
Observation time |
Rabbit no. |
||||||
1 |
2 |
3 |
|||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
||
1 h |
2 |
0 |
2 |
1 |
2 |
0 |
|
24 h |
3 |
1 |
3 |
3 |
3 |
2 |
|
48 h |
2 |
2 |
3 |
2 |
3 |
2 |
|
72 h |
2 |
2 |
3 |
2 |
3 |
2 |
|
Mean value 24 + 48 + 72 h |
2.33 |
1.67 |
3.0 |
2.3 |
3.0 |
2.0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Skin irrit 2, H315
DSD: Xi, R38
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