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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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