Registration Dossier
Registration Dossier
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EC number: 278-860-3 | CAS number: 78182-00-0
Eye irritation
Administrative data
- Endpoint:
- eye 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; 72-hour observation period, but with complete reversibility of all irritation reactions)
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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 72-hour observation period, but with complete reversibility of all irritation reactions
- Principles of method if other than guideline:
- according to Fed. Reg. 38, No. 187, 1973
- 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 / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler (company); 6050 Offenbach / Main
- Weight at study initiation: mean body weight of 3.05 kg for males, 2.70 kg for females
- 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml of crushed test substance (corresponding to approx. 71 mg); into the conjunctival sac of the right eye. - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 6 (3 males and 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
Test substance was not washed-out.
SCORING SYSTEM: according to Draize, 1959
Readings: 1 h, 24 h, 48 h, 72 h after application
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Remarks:
- of all animals
- Time point:
- other: 24-48-72-hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: No corneal opacity was seen.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all animals
- Time point:
- other: 24-48-72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: No effects in the iris were seen.
- Irritation parameter:
- conjunctivae score
- Remarks:
- erythema
- Basis:
- mean
- Remarks:
- of all animals
- Time point:
- other: 24-48-72 hours
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: erythema was observed in 4/6 animals after 24 hours (4 animals with erythema scores of 1 and one of erythema score 2) and persisted in 3 animals (including the one with the most marked response after 24 hours) after 48 hours (score of 1 for each).
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all animals
- Time point:
- other: 24-48-72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: only 1/6 animal showed chemosis of score 1 after 24 hours.
- Other effects:
- Secretion was observed in one animal (score of 1) after 24 and 48 hours, but was fully reversible within 72 hours.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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