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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
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:
according to guideline
Guideline:
other: Litchefield and Wilsoxon
Version / remarks:
J. Pharm, 96 99-113, 1949
Principles of method if other than guideline:
Method similar to OECD testing guideline.
GLP compliance:
no
Test type:
standard acute method
Limit test:
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:
NMP Crystals, 2-nitro-2-methyl-1-propanol, 99.6% purity CAS Number 76-39-1

Test animals

Species:
rat
Strain:
other: Cox-SD albino
Sex:
male/female
Details on test animals or test system and environmental conditions:
Test animals were male and female Cox-SD albino rats, weighing 200 +/- 25 g. Animals were fasted prior to dosing.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Test material was delivered by gavage as a single dose. Animals were fasted prior to dosing.
Doses:
Dose solution was prepared on a weight/volume basis in sterilized deionized water. The volume of the dosing soluition was adjusted according to the dose and the body weight of the animal; Dosing levels for males: 402; 570;800;1100;1600;2300 mg/kg. Dosing levels for females: 800; 1100; 1310; 1600; 2300 mg/kg
No. of animals per sex per dose:
10 male and 10 female
Control animals:
yes
Details on study design:
Following single dose by gavage animals were obserbed frequently on the day of dosing and daily thereafter for 14 days. Signs of mortality and morbidity were noted during this period. Animals dying during the observation period were necropsied on the same day or the next day if the animal died during the night. At the end of the 14 days surviving animals were weighed, sacrificed and examined for gross pathology. The oral LD50 was estmated according to the method of Litchfield and Wilcoxon.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
1 480 mg/kg bw
Based on:
test mat.
95% CL:
> 1 370 - < 1 598
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
845 mg/kg bw
Based on:
test mat.
95% CL:
> 710 - < 1 150
Mortality:
Male rats: there was 1 death at 570 mg/kg; 5 deaths at 800 mg/kg; 8 deaths at 1100 mg/kg; 9 deaths at 1600 mg/kg and 10 deaths at 2300 mg/kg
Female rats: there were 4 deaths at 1310mg/kg; 7 deaths at 1600 mg/kg and 10 deaths at 2300 mg/kg
Clinical signs:
At 800 mg/kg male rats were lethargic and ataxic; at higher dose levels male rats were prostrate and had labored respiration;
Female rats at the two highest doses were prostrate and 7/10 showed mild hematuria.
Gross pathology:
Some evidence of mottled liver in male rats in three highest dose level. All organs were normal for female rats

Applicant's summary and conclusion

Conclusions:
The acute oral LD50 in the male rat was 845 (710-1150) mg/kg and in the female rat was 1480 (1370-1598) mg/kg, leading to the conclusion that the substance was more toxic to male than female rats.