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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: The HPVIS rating for this study is “Excellent” and it is selected as a “Key Study”.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
Instillation into conjunctival sac of one eye from glass syringe. The eyes (cornea, iris and conjunctiva) were examined immediately pre-treatment. For treatment, the lower lid was gently pulled away from the eye. 0.1 mL of undiluted NG was then placed in the sac thus formed. The eyelids were then gently held together briefly ensure adequate distribution. The contra lateral eye served as the untreated control. One minute post-treatment, the eyelids of the treated eyes of three rabbits were everted and rinsed with 300 mL of water over a period of three minutes. The treated eye areas of all six rabbits were examined at 1 h, 24 h, 48 h, 72 h and 7 days post-treatment.
GLP compliance:
yes
Remarks:
Complied with FDA GLP regulations of 6/20/79, proposed TSCA GLP regulations of 5/9/79, and proposed FIFRA GLP regulations of 4/18/80.

Test material

Constituent 1
Chemical structure
Reference substance name:
Glycerol trinitrate
EC Number:
200-240-8
EC Name:
Glycerol trinitrate
Cas Number:
55-63-0
Molecular formula:
C3H5N3O9
IUPAC Name:
propane-1,2,3-triyl trinitrate
Specific details on test material used for the study:
The test material was neat NG, isolated from an ethanol solution immediately prior to testing (it is unsafe to transport the undiluted material). Isolation was by a chemical engineer from sponsor's nearby NG plant who was familiar with chemistry, physical properties and handling of NG. The ethanol solution was from commercial production (usually 99+ per cent pure). An analysis was not supplied.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST TYPE: Single dose (acute) Eye Irritation
SEX: 6 male rabbits

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
single dose administration
Observation period (in vivo):
Rabbits were observed 1, 24, 48, 72 hours and 7 days post-treatment
Number of animals or in vitro replicates:
6 (3 administered treatment without washing, 3 administered treatment with washing)
Details on study design:
Instillation into conjunctival sac of one eye from glass syringe. The eyes (cornea, iris and conjunctiva) were examined immediately pre-treatment. For treatment, the lower lid was gently pulled away from the eye. 0.1 mL of undiluted NG was then placed in the sac thus formed. The eyelids were then gently held together briefly ensure adequate distribution. The contra lateral eye served as the untreated control. One minute post-treatment, the eyelids of the treated eyes of three rabbits were everted and rinsed with 300 mL of water over a period of three minutes. The treated eye areas of all six rabbits were examined at 1 h, 24 h, 48 h, 72 h and 7 days post-treatment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal: unwashed eye (1 of 3)
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal: unwashed eye (2 of 3)
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
other: washed eye (1 of 3)
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal: washed eye (2 of 3)
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal: washed eye (3 of 3)
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
animal: washed eye (1 of 3)
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Remarks:
conjuctival redness
Basis:
animal: washed eye (1 of 3)
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
conjunctival redness
Basis:
animal #1
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
conjunctival redness
Basis:
animal #2
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
conjunctival redness
Basis:
animal #3
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation

Any other information on results incl. tables

There was no miosis, mydriasis, other ocular effects or evidence of systemic effects in any of the rabbits treated. All rabbit eyes were normal when examined at all other post-treatment times.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Executive summary:

The only effects observed were at one hour post-dosing. They were: Draize rating "1" conjunctival discharge in the treated eyes of 2/3 rabbits whose eyes were not washed and in 3/3 rabbits whose eyes were washed. Rating "1" conjunctival chemosis was seen in 1/3 rabbits whose eyes were washed, and conjunctival redness was seen in another of the rabbits whose eye was washed after treatment. There was no miosis, mydriasis, other ocular effects or evidence of systemic effects in any of the rabbits treated. All rabbit eyes were normal when examined at all other post-treatment times.