Nitroethane

Acute Toxicity: oral

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

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Nitroethane

EC Number:

201-188-9

EC Name:

Nitroethane

Cas Number:

79-24-3

Molecular formula:

C2H5NO2

IUPAC Name:

nitroethane

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 or test system 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 levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1 428 mg/kg bw

Based on:

test mat.

95% CL:

1 232 - 1 657

Effect levels 2

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:

other: 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

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.