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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
weight of evidence
Study period:
May 1958
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1958
Report date:
1958

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
0.1 ml of a test item solution was instillated into the eyes of each of three albino rabbits. The right eye remained unwashed and the left eyes were irrigated with water for 20s after the instillation of the material. With the aid of fluorescein staining and a hand-slit-lamp, the eyes were examined one hour, four hours and 24 hours after treatment, and where possible daily after, until the animals were sacrificed. Microscopic examination of corneas were also carried out.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Reaction mass of N,N'-ethylenebis[N-methyl-2-[(1-oxo-9-octadecenyl)oxy]-N-[2-[(1-oxo-9-octadecenyl)oxy]propyl]propylammonium] dimethyl disulphate and [2-[bis(2-hydroxypropyl)amino]ethyl]bis(2-hydroxypropyl)(methyl)ammonium methyl sulphate, dioleate (ester)
EC Number:
916-222-4
Molecular formula:
C51H99N2O6.CH3O4S
IUPAC Name:
Reaction mass of N,N'-ethylenebis[N-methyl-2-[(1-oxo-9-octadecenyl)oxy]-N-[2-[(1-oxo-9-octadecenyl)oxy]propyl]propylammonium] dimethyl disulphate and [2-[bis(2-hydroxypropyl)amino]ethyl]bis(2-hydroxypropyl)(methyl)ammonium methyl sulphate, dioleate (ester)
additive 1
Chemical structure
Reference substance name:
Propane-1,2-diol
EC Number:
200-338-0
EC Name:
Propane-1,2-diol
Cas Number:
57-55-6
Molecular formula:
C3H8O2
IUPAC Name:
propylene glycol

Test animals / tissue source

Species:
rabbit
Strain:
other: albino

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1ml 100% test substance, 10% test substance, 1.5% test substance
Duration of treatment / exposure:
20s
Observation period (in vivo):
24 hours (min) - 23 days (max)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
other: 100%
Time point:
24 h
Reversibility:
not fully reversible within: 22 days
Remarks on result:
probability of severe irritation
Irritation parameter:
cornea opacity score
Basis:
other: 100%
Time point:
24 h
Remarks on result:
probability of severe irritation
Irritation parameter:
cornea opacity score
Basis:
other: 10 %
Time point:
24 h
Reversibility:
fully reversible within: 3 days
Remarks on result:
probability of moderate irritation
Irritation parameter:
conjunctivae score
Basis:
other: 1.5%
Time point:
24 h
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Undiluted test substance caused corneal damage when instilled into the eyes of rabbits