Registration Dossier
Registration Dossier
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EC number: 224-388-8 | CAS number: 4337-75-1
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
- Remarks:
- Read-across study
- Justification for type of information:
- This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Refer to section 13 for read-across justification.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
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:
- Fatty acid chlorides, C12-18 (even numbered) and C18 unsatd., reaction products with sodium N-methyltaurinate
- EC Number:
- 939-529-5
- Molecular formula:
- not applicable, substance is a UVCB substance containing several constituents
- IUPAC Name:
- Fatty acid chlorides, C12-18 (even numbered) and C18 unsatd., reaction products with sodium N-methyltaurinate
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
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: 2.0 - 3.8 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): 12 - 15
- 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): 500 mg/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 bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scoring system.1
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0.1
- 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
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- other: no irritation reactions
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- other: no irritation reactions
- Irritation parameter:
- edema score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- other: no irritation reactions
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- other: no irritation reactions
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- other: no irritation reactions
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- other: no irritation reactions
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the study results, the read-across analogue source substance sodium methyl cocoyl taurate (SMCT) is not irritating to rabbit skin.
This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Hence, SMLT is expected to be non-irritating to the skin. - Executive summary:
The primary skin irritation potential of sodium methyl cocoyl taurate (SMCT) 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.The test item was applied over the whole surface of a 2.5 x 2.5 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 oedema were evaluated numerically according to the score of DRAIZE. Slight to well defined erythemas were observed in all animals shortly after removal of the plaster at the 30 - 60 minute reading. Only one animal showed a slight erythema 24 hours after exposure. Form the 48 h reading in this animals and from the 24 hour reading in the remaining 2 animals until the end of the study no signs of irritation were observed in any of the animals. The overall mean scores after 24, 48 and 72 hours were 0.1 for erythema and 0.0 for edema. Based on the study results, no skin irritating potential is attributable to SMCT in rabbits under the described test conditions.
This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Hence, SMLT is expected to be non-irritating to the skin.
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