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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
Study was in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

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 81-5 (Acute Dermal Irritation)
Version / remarks:
Following a four hour exposure sites were visually scored for edema, erythema and tissue destruction at 4, 24 and 48 hours
Deviations:
not applicable
Principles of method if other than guideline:
The skin corrosion potential of the test substance was assessed in rabbits. 0.5 g of the test substance were applied on the shaved back of each animal, which was covered with an occlusive dressing. After 4 hours, the skin area was cleaned and the skin sites were examined for erythema and edema. The skin sites were examined again 24 and 48 hours after exposure.
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

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS: Weight at study initiation: 3.0 ± 0.5 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g powder per site
Duration of treatment / exposure:
4 hours
Observation period:
48 hours
Number of animals:
6
Details on study design:
The skin sites were examined for erythema, edema and tissue destruction 4, 24 and 48 hours after exposure. - Area of exposure: The skin from the back area of each rabbit was shaved free of hair. 0.5 g of the test substance was applied and the back was covered with a fabric patch and occluded with tape. The entire trunk was loosely wrapped with an impervious rubber cloth and by a stainless steel protective screen held in place by tape. Following a 4 hour exposure the patched were removed, the treated sites cleaned and visually examined for erythema, edema and tissue destruction at 4, 24 and 48 hours following exposureSkin reactions of erythema, edema, or tissue destruction was noted and recorded. Any tissue destruction will be scored as a positive reaction (according to Draize, Association of Food and Drug O f f i c i a l s of the United States, p. 48, 1959).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Reversibility:
other: Not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Reversibility:
other: Not applicable
Irritant / corrosive response data:
No erythema, edema or corrosion was reported at any time during the observation period.
Other effects:
No data.

Any other information on results incl. tables

Corrosion results

Irritation parameter

Basis

Time point

Score

Reversibility

Remarks

erythema score

mean (of all 6 animals)

4,24,48 hr

0

other: reversibility not applicable

 

edema score

mean (of all 6 animals)

4,24,48 ht

0

other: reversibility not applicable

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Not corrosive to the skin.