Registration Dossier

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:
1981
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

Constituent 1
Chemical structure
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

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