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Administrative data

Description of key information

Skin: not irritating

Eye: irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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
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
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
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).
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.

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

 

Interpretation of results:
GHS criteria not met
Conclusions:
Not corrosive to the skin.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation

Two skin irritation studies with 2-nitro-2-methyl-1-propanol (NMP) are available. One of these studies was performed with NMP crystals, and the other with a diluted product approximately 70% ai.In a key study, conducted with NMP crystals (Parekh, 1980) 0.5 g of the test substance was applied to shaved skin and covered with an occlusive dressing for 24 hours. The test substance caused slight erythema on 3 of the exposed skin sites within 24 hours. The effects were fully reversible within 72 hours in 6/6 animals. Under the conditions of this study (24 h exposure) the test substance is considered non-irritating to the skin. A supporting study with NMP concentrate (Parekh, 1979) run under the same conditions resulted in no erythema or edema in any of the test animals.

Skin Corrosion:

 In a key study with NMP crystal (Parekh, 1980) conducted to assess the specific skin corrosion potential of the test substance in rabbits. The skin on the back of the animals was shaved and 0.5 g of the test substance applied and covered with an occlusive dressing for 4 hours. The skin was then cleaned and examined. No erythema or edema was observed in any of the animals 24 and 48 hours after exposure ended. A supporting study with NMP concentrate (Parekh, 1979) run under the same conditions.provided identical results.

Eye irritation:

Two eye irritation studies with 2-nitro-2-methyl-1-propanol (NMP) are available. One of these studies was performed with NMP crystals, and the other with a diluted product approximately 70% ai.

In a key study, conducted with NMP crystals (Parekh, 1980) 0.1 g the test substance was instilled into the lower conjunctival sac of the right eyes of 6 albino rabbits. The eyes were held closed for 1-2 seconds to prevent loss of test material. The left eye of each animal served as an untreated control. Eyes were examined at 24,48 and 72 hours post treatment. At 72 hours and on the 7thday a drop of sodium fluorescein (0.24%) was placed in the eye and the excess fluorescein was flushed with sterile saline (85%), and the eye was examined under a UV light for corneal lesions. The test material affected the cornea, iris and conjunctiva in all the rabbits. The lesions were still visible at 72 hours. At 72 hours, following the sodium fluorescein treatment, the eyes of all the rabbits showed corneal scarred, and when reexamined on the 7thday, they showed little recovery.

In a supporting study, conducted with NMP concentrate (Parekh, 1979) 0.1 ml of the test substance was instilled into the lower conjunctival sac of the right eyes of 6 albino rabbits. The eyes were held closed for 1-2 seconds to prevent loss of test material. The left eye of each animal served as an untreated control. Eyes were examined at 24,48 and 72 hours post treatment. On the 8thday a drop of sodium fluorescein (0.24%) was placed in the eye and the excess fluorescein was flushed with sterile saline (85%), and the eye was examined under a UV light for corneal lesions. The test material affected the cornea, iris and conjunctiva in all but one of the rabbits. The remaining rabbit (#6) had shaken its head following instillation which may have caused the test material to drip out.  The lesions were still visible at 72 hours. At 72 hours, following the sodium fluorescein treatment, the eyes of all the rabbits showed corneal scarred, and when reexamined on the 8th day, they showed little recovery.

Justification for classification or non-classification