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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted similar to guidelines and in compliance with GLPs.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Guideline not mentioned in report
Principles of method if other than guideline:
Similar to guideline study.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Propane-1,2-diol, propoxylated
EC Number:
500-039-8
EC Name:
Propane-1,2-diol, propoxylated
Cas Number:
25322-69-4
Molecular formula:
(C3 H6 O)n H2 O n= >1 - <4.5
IUPAC Name:
propane-1,2-diol, propoxylated
Details on test material:
product name: Propane-1,2-diol, propoxylated
MW= 230

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Source: Hazelton Research Products, Denver, PA
Age: 8-12 weeks
Weight: 2.566-2.835 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml/treated eye
Duration of treatment / exposure:
Once
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
The undiluted test article (0.1 ml) was placed in the conjunctival sac of the right eye of six rabbits. The left eye remained untreated and served as the control. The eyes were examined at 1, 24, 48 and 72 hours after treatment. The grades of ocular reaction were recorded using the method of Draize, J.H. 1965. Body weights were collected at the start and at termination of the study. The study was terminated following the 72-hour observation period.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
M1
Time point:
other: 24,48,72 hr average
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
M1
Time point:
other: 24,48,72 hr average
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
M1
Time point:
other: 24,48,72 hr average
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
M1
Time point:
other: 24,48,72 hr average
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
M2
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
M2
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
M2
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
M2
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
M3
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
4
Reversibility:
other: not qppliacable
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
M3
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
M3
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
M3
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
cornea opacity score
Basis:
animal #4
Remarks:
F1
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #4
Remarks:
F1
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #4
Remarks:
F1
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
chemosis score
Basis:
animal #4
Remarks:
F1
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #5
Remarks:
F2
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #5
Remarks:
F2
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #5
Remarks:
F2
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
chemosis score
Basis:
animal #5
Remarks:
F2
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hrs
Irritant / corrosive response data:
The draize scores at 1, 24, 48 and 72 hours were 5.3, 0, 0, and 0, respectively.

Any other information on results incl. tables

Irritation parameter Basis Time point Max. score Reversibility Remarks
cornea score mean 1 hour 0 4
cornea score mean 24 hours 0 4
cornea score mean 48 hours 0 4
cornea score mean 72 hours 0 4
iris score mean 1 hour 0 2
iris score mean 24 hours 0 2
iris score mean 48 hours 0 2
iris score mean 72 hours 0 2
conjunctivae score mean 1 hour 2 3 fully reversible within: 24 hours
conjunctivae score mean 24 hours 0 3
conjunctivae score mean 48 hours 0 3
conjunctivae score mean 72 hours 0 3
chemosis score mean 1 hour 0.83 4 fully reversible within: 24 hours
chemosis score mean 24 hours 0 4
chemosis score mean 48 hours 0 4
chemosis score mean 72 hours 0 4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information uncategorizable: minimally irritating, clears within 24 hours Criteria used for interpretation of results: EU
Conclusions:
The test material was minimally irritating to the eyes of rabbits after 1 hour and cleared within 24 hours. The material does not need to be classified for eye irritation according to EU GHS.