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Administrative data

Description of key information

Nitromethane was not irritating to intact skin and caused minor irritation to the eye of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 Oct 1980 - 23 Oct 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Rabbits were at least 9 weeks of age and weighed 2 kg. Rabbits were individually caged during and after exposure. Rabbits were quarantined for at least 7 days. Animals were fed Purina Certified Rabbit Chow #5322 and water ad libitum. The diet was certified free of contaminants and the analysis was performed by the supplier. Every quarter the animals' drinking water was analyzed to ensure that the levels of contaminants were equal to or less than the recommended levels as per the Primary Drinking Water Regulations (40 CFR 141.11, 141.12, 141.14).
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
4, 24 and 48 hours after application of the test material.
Number of animals:
6
Details on study design:
To a hair free area on the back, the test material was applied under a 1 inch square gauze patch and then with an impervious rubberized cloth. The test material was applied to a single intact skin site per rabbit. The test material was left in contact with the skin for four hours. After exposure, the skin sites were wiped clean and left exposed to the air for the duration of the study. The treated skin site was visually examined for erythema, edema or any irreversible tissue destruction at 4, 24 and 48 hours after the inital application of the material. Skin reactions of erythema, edema or tissue destruction was noted and reported. Any tissue destruction was scored as a positive reaction (according to Draize, Association of Food and Drug Officials of the United States, p 48, 1959). Body weights were measured and recorded at 0 and 48 hours after exposure. Any animals which died during the test were necropsied and examined for tissues or organ damage. At 48 hours after the skin site examination, the animals were sacrificed by intravenous administration of benzyltrimethylammonium chloride.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 hr
Score:
0
Max. score:
0
Reversibility:
other: not irritating at any time point
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not irritating at any time point
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: not irritating at any time point
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48 h
Score:
0
Max. score:
0
Reversibility:
other: not irritating at any time point
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 hr
Score:
0
Max. score:
0
Reversibility:
other: not irritating at any time point
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not irritating at any time point
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: not irritating at any time point
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48 h
Score:
0
Max. score:
0
Reversibility:
other: not irritating at any time point
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48 h
Score:
0
Max. score:
0
Reversibility:
other: not irritating at any time point
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Nitromethane was not irritating to the skin
Other effects:
Day 0 mean body weight was 2.789 +/- 0.127 kg while day 2 mean body weight was 2.826 +/- 0.118 kg.

No additional information available.

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Nitromethane was not irritating when applied to the skin.
Executive summary:

The dermal irritation potential of nitromethane was examined with rabbits. Nitromethane was not irritating to the skin of rabbits.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
circa 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
no guideline available
Principles of method if other than guideline:
The test procedure employed was described in The Federal Register, Title 21, Part 191, para, 191.12. and was conducted briefly as follows: 0.1 ml of the test material was introduced into a cup formed by retracting the lower eyelid of the right eye of each of six albino rabbits. After introduction of the test substance, the eyelid was held closed for one second. The test animals were maintained without further treatment and their eyes were examined at 24, 48 and 72 hours after treatment. .
GLP compliance:
no
Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
No additional information available.
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
After introduction of the test substance, the eyelid was held closed for one second. The test animals were maintained without further treatment and their eyes were examined at 24, 48 and 72 hours after treatment.
Observation period (in vivo):
Eyes were examined at 24, 48 and 72 hours after treatment. Examination of the treated eyes was aided by use of a hand-held slit lamp and spectacle lupes. After the 24-hr examination, a drop of fluorescein sodium opthalmic solution was placed into each subjects's eye to aid in the visualization of possible damage to the cornea. Responses of the eyes were graded by the Draize technique as modified and presented in Illustrated Guide for Grading Eye Irritation by Hazardous Substances, prepared by the Bureau of Scientific Research, Food and Drug Administration.
Number of animals or in vitro replicates:
6
Details on study design:
The test material (0.1 ml) was introduced into a cup formed by retracting the lower eyelid of the right eye of each of 6 albino rabbits. The eyelids were held closed for one second. Eyes were examined 24, 48 and 72 hours after treatment. A hand-held slit lamp and spectacle loupes were used to examine eyes. After the 24 hour examination, a drop of fluorescein sodium ophthalmic solution was placed in each eye to help identify corneal damage.

Responses of the eyes were graded by the Draize technique. Responses of the cornea and iris were given scores of 0-4 and 0-2, respectively. Conjuctival chemosis and redness were scored on scales of 0-4 and 0-3, respectively. The average corneal opacity, iris, chemosis and redness scores were determined for all six animals at each time point.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
< 1
Max. score:
1
Reversibility:
fully reversible within: 72 hr
Remarks on result:
other: The chemosis score was < 1 in 4 animals and 1 in one animal at 24 hours. At 48 hours, chemosis scores of 1 were listed for 2 animals. At 72 hours, these scores were <1. All other chemosis scores were 0.
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
< 1
Max. score:
1
Reversibility:
fully reversible within: 72 hr
Remarks on result:
other: The chemosis score was < 1 in 4 animals and 1 in one animal at 24 hours. At 48 hours, chemosis scores of 1 were listed for 2 animals. At 72 hours, these scores were <1. All other chemosis scores were 0.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0 - < 1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0 - < 1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0 - < 1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0 - < 1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
< 1
Max. score:
1
Reversibility:
fully reversible within: 72 hr
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
< 1
Max. score:
1
Reversibility:
fully reversible within: 72 hr
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Corneal opacity and iridial scores were 0 for all animals at all time points. The chemosis score was < 1 in 4 animals and 1 in one animal at 24 hours. At 48 hours, chemosis scores of 1 were listed for 2 animals. At 72 hours, these scores were <1. All other chemosis scores were 0. At 24 hours, redness scores of <1 and 1 were listed for 2 animals. At 48 hours the score of <1 at 24 hours had resolved to 0, but the other score was still a 1. This score resolved to 0 at 72 hours. All other redness scores were 0. The average chemosis scores at 24, 48 and 72 hours were listed as <1. The average redness scores at 24, 48 and 72 hours were <1, <1 and 0.

There was no indication of ulceration or other surface lesions after instillation of fluorescein. The eyes of 3 rabbits showed signs of moderately excessive lacrimation at the 48 and 72 hour examinations.
Other effects:
No additional information available.

No additional information available.

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The results reveal that treatment of the eyes of test rabbits with the test materials listed above caused no significant change in any of the parameters studied in the test for eye irritants.
Executive summary:

The eye irritation potential of nitromethane was examined. Slight irritation, which was considered to be not significant, was noted in the eyes of rabbits treated with nitromethane.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Nitromethane was not irritating to intact skin following application of 0.5 ml test material to intact skin for 24 hours in a dermal irritation study. Slight irritation was noted in abraded skin after 24 hours which appeared to be healing by 96 hours. Since current guidelines recommend only testing intact skin, only data from intact skin was used.

The eye irritation potential of nitromethane was examinedby instilling 0.1 ml into the eyes of six albino rabbits. Corneal opacity and iridial scores were 0 for all animals at all time points. The chemosis score was < 1 in 4 animals and 1 in one animal at 24 hours. At 48 hours, chemosis scores of 1 were listed for 2 animals. At 72 hours, these scores were <1. All other chemosis scores were 0. At 24 hours, redness scores of <1 and 1 were listed for 2 animals. At 48 hours the score of <1 at 24 hours had resolved to 0, but the other score was still a 1. This score resolved to 0 at 72 hours. All other redness scores were 0. The average chemosis scores at 24, 48 and 72 hours were listed as <1. The average redness scores at 24, 48 and 72 hours were <1, <1 and 0.

Justification for selection of skin irritation / corrosion endpoint:

The study was not conducted according to guidelines but was conducted according to GLPs and the report contains sufficient data for interpretation of study results

Justification for selection of eye irritation endpoint:

This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Nitromethane was not irritating when applied to intact skin and therefore not classifiable under GHS

Nitromethane was only slightly irritating to the eyes and not classifiable under GHS.