Registration Dossier
Registration Dossier
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EC number: 278-860-3 | CAS number: 78182-00-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well conducted study similar to guideline (no GLP; TS purity not specified; TS applied as 80% aqueous preparation, occlusive application, 8 days observation period)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- TS applied as 80% aqueous preparation, occlusive application, 8 days observation period
- GLP compliance:
- no
- Remarks:
- well documented study with quality controlled data
Test material
- Reference substance name:
- (2-hydroxyethyl)(3-hydroxypropyl)dimethylammonium chloride
- EC Number:
- 278-860-3
- EC Name:
- (2-hydroxyethyl)(3-hydroxypropyl)dimethylammonium chloride
- Cas Number:
- 78182-00-0
- Molecular formula:
- C7H18NO2.Cl
- IUPAC Name:
- 3-hydroxy-N-(2-hydroxyethyl)-N,N-dimethylpropan-1-aminium chloride
- Details on test material:
- - Name of the test substance used in the study report: Dimethylaminopropanol + 1 EO Hydrochlorid
- Physical state: solid
No additional details provided
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler (company); 6050 Offenbach / Main
- Weight at study initiation: mean body weight of 3.17 kg (3.15 and 3.18 kg) for the 2 males, 2.93 kg for the female
- Clipping of the fur: at least 15 hours before study start
- Housing: one rabbit per cage (stainless steel; area 40 x 51 cm, no bedding)
- Diet (e.g. ad libitum): Ovator Solikanin 4 MM diet (about 130 g per animal and day) from Muskator-Werke, 4000 Duesseldorf
- Water (e.g. ad libitum): drinking water (daily about 250 ml per animal)
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: untreated site skin of the same animal
- Amount / concentration applied:
- about 0.5 g (test patch with 0.5 mm thick film of the 80% test substance preparation)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- up to 8 days
- Number of animals:
- 3 (2 males and 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: upper third of the back or flank region
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: no data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to Draize, 1959
Reading times: 30 - 60 min after removal of the test patches as well as 24 hours, 48 hours and 8 d after application. Because a slight irritation reaction present after 24 hours in one animal was completely reversible within 48 hours, no 72-reading was made.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: mean 24-48 hour
- Score:
- 0.15
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: a slight erythema (score 1) was present in 1 animals after 24 hours, but was completely reversible within 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: mean 24-48-hour
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no edema was observed at any time point
- Irritant / corrosive response data:
- No irritation reaction was observed at the end of the observation period (8 days after treatment).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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