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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 Oct 1980 - 8 Sept 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to test guidelines and/or standard method and in accordance with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Production lot sample no. OE245A. The submitted sample was a clear liquid. The analytical data sheet submitted with the sample showed the following analysis: wt%Nitroethane 96.52Nitromethane 0.012-Nitropropane 3.38Water 0.022

Test animals

Species:
rat
Strain:
other: Cox-SD
Sex:
male/female
Details on test animals and environmental conditions:
According to the protocol:Specie: RatStrain: Sprague-Dawley albino whiteSex: Equal numbers of male and femaleSource: Laboratory Supply, Indianapolis, INAge/Weight: At least 6 weeks/160-150 g (report states rats weighed 204 +/- 17 g)Identification: Individually numbered by body markingsHousing: Ten per cage. During the quarantine and after dosingQuarantine: At least 4 days.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
1% solution
Details on oral exposure:
Nitroethane (P-1355) was suspended in a 1% CMC solution and was administered by gavage in a single dose to Cox-SD albino rats weighing 204±17 g. The dosing solution was prepared on weight/volume basis. Ten male and ten female rats were used per dose level. The animals were fasted prior to dosing. The volume of the dosing solution was adjusted according to the dose and the body weight of the animal.
Doses:
The selected oral doses administered to the male and female rats were 0, 560, 800, 1100, 1600, and 2300 mg/kg. Additional dose levels of 950,1000, 1050, and 1250 mg/kg were administered to female rats only along with appropriate controls. For identification, the earlier dosed female rats were labelled as Group I and the later dosed female rats were labelled as Groups II (950), III (1000, 1050), and IV (950, 1050, 1250).
No. of animals per sex per dose:
Group I, 10 male and 10 female rats/dose. For groups II, III and IV, 10 female rats/dose.
Control animals:
yes
Details on study design:
All the animals in this study were observed frequently on the day of the compound administration and thereafter for 14 days. Any unusual signs of toxicity or death were noted during this period. The animals that died 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 14 days, the surviving animals were weighed, sacrificed and examined for gross pathology.
Statistics:
The oral LD50' values, the 95% confidence limits (shown in parenthesis), and the slope (±SE) were calculated according to Finney (Probit Analysis, Cambridge University Press 1971) adapted to BASIC computer program.

Results and discussion

Preliminary study:
Not applicable.
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1 428 mg/kg bw
Based on:
test mat.
95% CL:
1 232 - 1 657
Sex:
female
Dose descriptor:
LD50
Effect level:
1 083 mg/kg bw
Based on:
test mat.
95% CL:
991 - 1 167
Mortality:
See Table 1 below.
Clinical signs:
After oral dosing, the males at doses >800 mg/kg and the females at doses >1000 mg/kg were lethargic and ataxic by the fourth hour. The females showed anorexia, bloody nares at day 1, and hematuria and bloody feces by days 2 and 3. In both sexes the above conditions lasted from two to three days. The animals were normal by day seven.
Body weight:
See Table 1 below.
Gross pathology:
The necropsy of the animals found dead during the observation period showed severe intestinal hemorrhage.The necropsy of the surviving animals at day 14 showed that some of the male·and female rats, including the controls, showed lung infections. The other organs were grossly normal.
Other findings:
No additional information below.

Any other information on results incl. tables

Table 1 Acute Oral Toxicity of P-1355 in Rats

        Mortality  

 Dose

mg/kg

 Ave. Body Wt. Gain Dead/Treated  No/Day of Study

 Gross Pathological Observations*

     Male        
 0  50  0/10  --

 All organs normal

 560  40  0/10  --

 #8, 9 lung infection

 800  42  0/10  --

 #2 lung infection

 1100  43  0/10  --

 All organs normal

 1600  43  7/10  --

 #6 lung infection

 2300  --  10/10  --

 --

     Female        
 Group I      

 

 0

 23

 0/10

 --

 All organs normal

 560

13

 0/10

 --

 800

 16

 0/10

 --

 All organs normal

 1100

 18

 8/10

 1/1, 7/2

 All organs normal

 1600

 --

 10/10

 7/1, 3/2

 --

 2300

 --

 10/10

 4/1, 5/2, 1/3

 --

 Group II

 

 

 

 

 0

 7

 0/10

 --

 #2 lung infection

 950  5  0/10  --

 All organs normal

 Group III        
 0  15  0/10  --

 #10 lung infection

 1000  14  4/10  --

 All organs normal

 1050  8  6/10  1/1, 3/2, 1/3, 1/5

 All organs normal

 Group IV        
 0  23  0/10  --

 #2, 3, 4, 7, 8 lung infection

 950  21  0/10  --

 #1, 2, 4, 5 lung infection

 1050  16  0/10  --

 #1 lung infection

 1250  15  7/10  3/1, 1/2, 3/3

 All organs normal

*On surviving animals

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The acute oral.LD50 of nitroethane (P-1355) in male rats was 1428 (1232-1657) mg/kg and in the female rats was 1083 (991-1167) mg/kg.
Executive summary:

The acute oral toxicity of nitroethane was examined. The acute oral.LD50 of nitroethane (P-1355) in male rats was 1428 (1232-1657) mg/kg and in the female rats was 1083 (991-1167) mg/kg.