Registration Dossier
Registration Dossier
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EC number: 242-893-1 | CAS number: 19223-55-3
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February - August 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxooctyl)amino]propyl]ammonium hydroxide
- Molecular formula:
- C16H34N2O5S
- IUPAC Name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxooctyl)amino]propyl]ammonium hydroxide
- Reference substance name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxodecyl)amino]propyl]ammonium hydroxide
- Molecular formula:
- C18H38N2O5S
- IUPAC Name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxodecyl)amino]propyl]ammonium hydroxide
- Reference substance name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxododecyl)amino]propyl]ammonium hydroxide
- EC Number:
- 242-893-1
- EC Name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxododecyl)amino]propyl]ammonium hydroxide
- Cas Number:
- 19223-55-3
- Molecular formula:
- C20H42N2O5S
- IUPAC Name:
- N-[3-(dodecanoylamino)propyl]-2-hydroxy-N,N-dimethyl-3-sulfopropan-1-aminium hydroxide
- Reference substance name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxotetradecyl)amino]propyl]ammonium hydroxide
- Molecular formula:
- C22H46N2O5S
- IUPAC Name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxotetradecyl)amino]propyl]ammonium hydroxide
- Reference substance name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxohexadecyl)amino]propyl]ammonium hydroxide
- Molecular formula:
- C24H50N2O5S
- IUPAC Name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxohexadecyl)amino]propyl]ammonium hydroxide
- Reference substance name:
- [2-hydroxy-3-sulphopropyl]dimethyl[3-[(1-oxooctadecyl)amino]propyl]ammonium hydroxide
- EC Number:
- 264-390-6
- EC Name:
- [2-hydroxy-3-sulphopropyl]dimethyl[3-[(1-oxooctadecyl)amino]propyl]ammonium hydroxide
- Cas Number:
- 63663-12-7
- Molecular formula:
- C26H54N2O5S
- IUPAC Name:
- 2-hydroxy-N,N-dimethyl-N-[3-(stearoylamino)propyl]-3-sulfopropan-1-aminium hydroxide
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Water
- Reference substance name:
- Sodium chloride
- EC Number:
- 231-598-3
- EC Name:
- Sodium chloride
- Cas Number:
- 7647-14-5
- Molecular formula:
- ClNa
- IUPAC Name:
- sodium chloride
- Reference substance name:
- Glycerol
- EC Number:
- 200-289-5
- EC Name:
- Glycerol
- Cas Number:
- 56-81-5
- Molecular formula:
- C3H8O3
- IUPAC Name:
- glycerol
- Reference substance name:
- Disodium 2-hydroxypropane-1,3-disulfonate
- Molecular formula:
- C3H8O7S2.Na2
- IUPAC Name:
- Disodium 2-hydroxypropane-1,3-disulfonate
- Reference substance name:
- Sodium (±)-2,3-dihydroxypropanesulphonate
- EC Number:
- 252-542-4
- EC Name:
- Sodium (±)-2,3-dihydroxypropanesulphonate
- Cas Number:
- 35396-47-5
- Molecular formula:
- C3H8O5S.Na
- IUPAC Name:
- sodium (±)-2,3-dihydroxypropanesulphonate
- Reference substance name:
- Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl]
- EC Number:
- 930-947-3
- IUPAC Name:
- Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl]
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approx. 8 weeks old
- Weight at study initiation: 320-348 g (males) - 214-248 g (females)
- Fasting period before study: No
- Housing: By 5 from the same sex and group in polycarbonate cages with stainless steel lids containing autoclaved sawdust, with nylabone used as enrichment
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 8 days (males) - 5 days (females) before application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50 +/- 20
- Air changes (per hr): 12 cycles
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 05 March 2012 To: 23 March 2012
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approx. 7 x 5 cm for males, 6 x 5 cm for females
- % coverage: approx. 10% of total body surface
- Type of wrap if used: Application site covered with aerated hypoallergic dressing
REMOVAL OF TEST SUBSTANCE
No washing
TEST MATERIAL
- Solution applied as is.
- Quantity of test item applied adjusted based on the body weight recorded on the day of application.
- Correction factor of 2.76 used to calculate the dosage volume to be applied taking account of the solution purity. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg active ingredient/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
. Morbidity / mortality: frequently during hours following application, at least once daily for the remainder of the observation period
. Clinical signs: at least once during first 30 minutes, periodically during first 4 hours, once daily for the remainder of the observation period
. Bodyweight: recorded on the day of group allocation, then on the day of application (day 1) and on days 8 and 15
- Necropsy of survivors performed: yes (spleen was preserved in 10% buffered formalin, stored, and destroyed at finalization of study report) - Statistics:
- No statistical analyses included
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No unscheduled deaths observed
- Clinical signs:
- other: No clinical signs indicative of systemic toxicity observed. Very slight or well defined erythema noted at application site for 2 females on day 2.
- Gross pathology:
- Enlargement of the spleen was found in all treated animals but was considered incidental as it is part of the normal background in untreated rats of these strain and age.
- Other findings:
- Due to enlargement seen at necropsy, spleens were preserved in 10% buffered formalin and stored. In the absence of toxicological relevance, no histopathology was conducted and these organs were therefore destroyed upon finalization of the study report.
Any other information on results incl. tables
|
Females |
Males |
||
Historical controls |
Treated |
Historical controls |
Treated |
|
Dose level (mg/kg) |
0 |
2000 |
0 |
2000 |
Days 1-8 |
+36 |
+21 |
+45 |
+41 |
Days 8-15 |
+18 |
+16 |
+45 |
+44 |
Days 1-15 |
+55 |
+37 |
+90 |
+84 |
Mean bodyweight gains (grams) during the observation period
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 in rats was higher than 2000 mg active ingredient/kg bw.
- Executive summary:
Cocamidopropyl hydroxysultaine, as a 36.2% solution (Mackam CBS-50GE), has been tested for acute dermal toxicity in Sprague-Dawley rats. The test article was applied as a single dose under a semi-occlusive dressing for 24 hours. One group of 5 rats per sex received a dose of 2000 mg active ingredient/kg bw. Examinations for mortality and clinical signs were performed daily during the 14 -day study period. Animals were necropsied at the end of the observation period.
No mortality was observed. No clinical signs indicative of systemic toxicity were observed. Very slight or well defined erythema was noted at the application site for 2 females on day 2. Mean bodyweight gain was slightly lower than historical control data for females over the observation period, notably during the first week following application. However, no such changes were observed for males. Enlargement of the spleen was found in all treated animals but was considered incidental as it is part of the normal background in untreated rats of these strain and age.
The dermal LD50 in rats was therefore higher than 2000 mg active ingredient/kg bw.
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