Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

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: short study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(dimethylamino)propan-1-ol hydrochloride
EC Number:
601-495-1
Cas Number:
117829-74-0
Molecular formula:
C5 H13 N O. Cl H
IUPAC Name:
3-(dimethylamino)propan-1-ol hydrochloride
Details on test material:
- Name of the test substance used in the study report: 3-Dimethylamino-Propanol-Hydrochlorid-1
- Lot/batch No.: KT 215, Substance number: 00/0616-1

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
4 h
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
2
Details on study design:
SCORING SYSTEM: according to OECD Guideline 405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
At the 1-h reading both animals showed marked redness and chemosis (score 2) as well as slight discharge. At the 24-h reading redness with score 2 was still seen in the treated eyes of both animals. In 1/2 animals slight chemosis was observed (score 1). Slight redness of the conjunctivae persisted in both animals until the 72-h reading but was reversible within 7 days. The test substance is assessed as being not irritating to the eyes of rabbits under the present test conditions.

Any other information on results incl. tables

Mean conjunctivae score (24/48/72 h): 1.33 in 2/2 animals

Mean chemosis score (24/48/72 h): 0 in one animal, 0.33 in the other animal

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information