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Diss Factsheets

Administrative data

Endpoint:
eye irritation, other
Remarks:
In vivo study conducted in rabbits
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
In vivo methods considered acceptable

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methyl-2-nitropropan-1-ol
EC Number:
200-957-6
EC Name:
2-methyl-2-nitropropan-1-ol
Cas Number:
76-39-1
Molecular formula:
C4H9NO3
IUPAC Name:
2-methyl-2-nitropropan-1-ol
Details on test material:
Purity is above 99%.
Specific details on test material used for the study:
Name of test material (as cited in study report): P-184 or NMP Crystals ( 2-nitro-2-methyl-1-propanol) Lot # C-027907 CAS Number 76-39-1

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino; strain not specified
Details on test animals or tissues and environmental conditions:
Six albino rabbits weighing 3.0 +/- 0.5 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Amount / concentration applied:
0.1 g test material instilled into the lower conjunctival sac of the right eye. The left eye served as an untreated control
Duration of treatment / exposure:
Following instillation of test material, the eye lids were held closed for 1-2 seconds to prevent loss of the material. Eyes were examined at 24, 48 and 72 hours post treatment. At 72 hours and on the 7th day a drop of sodium fluororescein (0.24%) was placed in the eye and the excess fluoroscein was flushed with sterile saline (0.85%). The eye was examined under a UV light for corneal lesions.
Observation period (in vivo):
7 days
Details on study design:
Following instillation of test material, the eye lids were held closed for 1-2 seconds to prevent loss of the material. Eyes were examined at 24, 48 and 72 hours post treatment. At 72 hours and on the 7th day a drop of sodium fluororescein (0.24%) was placed in the eye and the excess fluoroscein was flushed with sterile saline (0.85%). The eye was examined under a UV light for corneal lesions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
37.7
Max. score:
42
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
36.8
Max. score:
42
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
36.5
Max. score:
42
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
Test material affected the cornea, iris and conjunctiva in all the rabbits. The severity od the lesions were still visible at 72 hours. At 72 hours after the sodium fluroescein treatment the treated eyes of all six rabbots showed corneal scarring and when re-examined on the 7th day they showed little recovery. Test material was determined to be a severe eye irritant.

Applicant's summary and conclusion