Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
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

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 81-2 (Acute Dermal Toxicity)
GLP compliance:
no
Limit test:
yes

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:
NMP Crystals, 2-nitro-2-methyl-1-propanol, 99.6% purity

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
Test was conduced using 10 rabbits (5 male; 5 female) weighing 2.9 +/- 0.5 kg. The abdomens of the rabbits were shaved free of hair and the skin in one group of rabbits was further prepared by abrasion.The abrasions were made with a blunt hypodermic needle without obtaining bleeding and were 2-3 cm apart over the area of exposure.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The abdomens of the rabbits were shaved free of hair and the skin in one group of rabbits was further prepared by abrasion.The abrasions were made with a blunt hypodermic needle without obtaining bleeding and were 2-3 cm apart over the area of exposure. Test material was ground to a fine powder. For each rabbit a weight amount of test material to give a dose of 2000 mg/kg was spread over the prepared abdominal are. The skin area was then covered with gauze and a sheet of impervious rubberized cloth to prevent loss of test material. The trunk was further enclosed with a flexible wire screen help in place by tape. Animals were then returned to their cages. After 24 hours the bindings and patches were removed and the exposed skin areas gently cleaned and observed for skin irritancy. The animals wre continued to be oberved for another 14 days.
Duration of exposure:
24 hours
Doses:
One dose: 2000 mg/kg
No. of animals per sex per dose:
10 (5 males' 5 females)
Control animals:
no
Details on study design:
For each rabbit a weight amount of test material to give a dose of 2000 mg/kg was spread over the prepared abdominal are. The skin area was then covered with gauze and a sheet of impervious rubberized cloth to prevent loss of test material. The trunk was further enclosed with a flexible wire screen help in place by tape. Animals were then returned to their cages. After 24 hours the bindings and patches were removed and the exposed skin areas gently cleaned and observed for skin irritancy. The animals wre continued to be oberved for another 14 days for any gross signs of toxicity. At the end of the 14 day observation period the animals were weighed, sacrificed and the organs examined for gross pathology

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
other: Limit test
Remarks:
No signs of toxicity or abnormal behavior. At necropsy organs in all animals were grossly normal
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
None
Body weight:
No significant change
Gross pathology:
No findings

Applicant's summary and conclusion