Registration Dossier
Registration Dossier
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EC number: 268-071-2 | CAS number: 68002-58-4 This substance is identified by SDA Substance Name: C14-C18 dialkyl dimethyl ammonium methyl sulfate and SDA Reporting Number: 17-049-00.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Principles of method if other than guideline:
- - Principle of test:
Six albino rats were used in this study. The hair was clipped from the back and flanks of each animal. The test material was applied to two areas on each of six animals, one abraded and one unabraded under a 1 x 1 inch 12 ply qauze patch held in place by 1/2 inch adhesive tape applied as an "X" over the patch. The trunk of the animals was then loosely wrapped in an impervious wrap for and exposure period of 4 hours. The wrap was applied loosely enough for the palm of the hand to be inserted between it and the animals back. After 4 hours of exposure, the patches were removed and the resulting reactions evaluated on the basis of the score described ihn the bottom section.
- Short description of test conditions:
Animals were held individually in screen bottom cages and were supplied with food and water ad libitum. During the exposure time the animals were immobilised in stocks.
- Parameters analysed / observed: erythema, edema - GLP compliance:
- no
- Remarks:
- study conducted prior to implementation of GLP
Test material
- Reference substance name:
- Quaternary ammonium compounds, di-C14-18-alkyldimethyl, Me sulfates
- Cas Number:
- 68002-58-4
- IUPAC Name:
- Quaternary ammonium compounds, di-C14-18-alkyldimethyl, Me sulfates
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: individually in screen bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: The hair was clipped and the substance was applied on intact and abraded skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Type of wrap if used: 1 x 1 inch 12 ply gauze patch held in place by 1/2 inch adhesive tape.
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) At 2 h, 4 h, 24 h, 48 h, 72 h
SCORING SYSTEM:
- Method of calculation:
The following score was used:
Erythema and Eschar formation: Score:
Slight erythema 1
Defined erythema 2
Moderate to severe erythema 3
Severe erythema to slight eschar formation 4
Edema formation: Score:
Slight edema (barly perceptible) 1
Defined edema (edges definite rising) 2
Moderate edema (area raised 1 mm) 3
Severe edema (raised more than 1 mm) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- intact skin site
- Basis:
- animal: #1 - #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- intact skin site
- Basis:
- animal: #1 - #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No edema or erythema were oberved at any time point, incl. 2 h and 4 h on intact and abraded skin sites.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, C14-18 alkyldimethyl ammonium methosulfate (89% a.i.) is not a dermal irritant.
- Executive summary:
In a primary dermal irritation study conducted prior to implementation of GLP and OECD guidelines, 6 young adult albino rabbits were dermally exposed to 0.5 g of C14-18 alkyldimethyl ammonium methosulfate (89% a.i.) for 4 hours to intact and abraded skin. Animals then were observed for 3 days. Irritation was scored by the method of Draize after 2, 4, 24, 48 and 72 h.
All edema and erythema scores were 0 at all timepoints on intact and abraded skin.
In this study, C14-18 alkyldimethyl ammonium methosulfate (89% a.i.) is not a dermal irritant.
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