Registration Dossier

Toxicological information

Eye irritation

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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: scientifically acceptable and sufficiently documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Principles of method if other than guideline:
2 animals, dose 50 mg/animal into the conjunctival sac, post exposure period 7 days.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Propylidynetrimethanol
EC Number:
201-074-9
EC Name:
Propylidynetrimethanol
Cas Number:
77-99-6
Molecular formula:
C6H14O3
IUPAC Name:
2-ethyl-2-(hydroxymethyl)propane-1,3-diol
Details on test material:
No data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the other eye of each of the 2 rabbits
Amount / concentration applied:
amount: 50 mg
Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2
Details on study design:
no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 0 h
Score:
>= 0 - <= 1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 2 and 7 d
Score:
0
Reversibility:
other: score = 0 at any time point
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
3
Reversibility:
other: score = 0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
3
Reversibility:
other: score = 0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
4
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
2
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
3
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
4
Remarks on result:
not measured/tested
Other effects:
no data

Any other information on results incl. tables

No data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

A dose of 50 mg/animal was applied into the conjunctival sac of one eye of each of 2 rabbits, postexposure observation period 7 days. Trimethylolpropane is not irritating (Bayer AG 1979).