Registration Dossier
Registration Dossier
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EC number: 939-538-4 | CAS number: 1471313-87-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
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:
- sodium 2-[(9E)-N-methyloctadec-9-enamido]ethane-1-sulfonate
- EC Number:
- 939-538-4
- Cas Number:
- 1471313-87-7
- Molecular formula:
- not applicable
- IUPAC Name:
- sodium 2-[(9E)-N-methyloctadec-9-enamido]ethane-1-sulfonate
- Test material form:
- other: solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3 - 5 month
- Weight at study initiation:
- Housing:individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/-20 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hours
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): o.5 mL per patch
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hour exposure
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100
- Type of wrap if used: semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after 4 hour exposure period
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study, the test material is not irritating to rabbit skin.
- Executive summary:
The primary skin irritation potential of the registration substance was evaluated according to OECD test guideline 404 using three New Zealand albino rabbits. Only animals with intact skin were used. Each animal was treated with 0.5 mL of undiluted test material moistered with NaCl.The test item was applied over the whole surface of a 2.5 x2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage. The exposure period was 4 hours. After the exposure all remnants of the test material were carefully removed from the skin with warm tap water. Examinations of the skin took place after 30-60 minutes as well as 24, 48 and 72 hours after removal of the patches. Erythema and edema were evaluated numerically according to the score of DRAIZE. Slight erythemas were observed in two animals up to 24 hours after removal of the plaster. Form the 48 h reading until the end of the study no signs of irritation were observed in any of the animals. The overall mean scores over all animals after 24, 48 and 72 hours were 0.2 for erythema and 0.0 for edema. Based on the study results,no relevant skin irritating potential is attributable to the registration substance in rabbits under the described test conditions.
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