Octahydro-2H-1-benzopyran-2-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been followed but not GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no details on test material (purity not indicated), no details on test animals and environmental conditions, observation period unknown (only until day 5 included in report).

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

1

Reference substance name:

Octahydro-2H-1-benzopyran-2-one

EC Number:

224-623-4

EC Name:

Octahydro-2H-1-benzopyran-2-one

Cas Number:

4430-31-3

Molecular formula:

C9H14O2

IUPAC Name:

octahydro-2H-1-benzopyran-2-one

Test material form:

liquid

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
No details.

ENVIRONMENTAL CONDITIONS
No details.

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

No details.

Doses:

1730, 2470, 3510 and 5000 mg/kg bw

No. of animals per sex per dose:

1730 mg/kg bw: total 20 (no sex specified)
2470, 3510 and 5000 mg/kg bw: 10 (no sex specified)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 5 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

3 900 mg/kg bw

Based on:

test mat.

95% CL:

2 600 - 5 900

Mortality:

See "any other information results"

Clinical signs:

other: 1730 mg/kg bw: Lethargy, chromorhynorrhea, piloerection, ptosis and diarrhea. 2470 mg/kg bw: Lethargy and flaccid muscle tone. 3510 mg/kg bw: Lethargy, chromorhynorrhea and piloerection. 5000 mg/kg bw: Lethargy, chromorhynorrhea, piloerection, ataxia, red

Any other information on results incl. tables

Deaths per day after exposure to Bicyclononalactone

Dose mg/kg	Deaths/day	total
1730	3/0, 1/1, 1/2, 1/5	6/20
2470	1/0, 2/1	3/10
3510	2/0, 1/1, 1/4	4/10
5000	3/0, 3/1	6/10

Necropsy observations after exposure to Bicyclononalactone

	No. of rats
Doses mg/kg bw	1730	2470	3510	5000
Normal	8	2		1
Cannabalized			2
Exudate, nose/mouth, red	2	3		2
Exudate, nose/mouth, yellow	1	1		3
Exudate, anogenital, brown	1
Exudate, anogenital, yellow	2
Exudate, nose/mouth, clear			1	2
Intestines, areas red
Intestines, areas yellow	4	4	1	9
Intestines, bloated	1
Stomach, areas red	1	1
Liver dark	8		2	4
Liver mottled		1	6	2
Lungs dark	1	3	2	4
Lungs areas dark	1	3		2
Consolidation of left lung *				1
Kidney dark	9	3	2	4
Kidney mottled	1		4
Spleen dark	2
Spleen large	2			4
Spleen, tip darker than normal		1
Bladder, contained blood			1	2

* Hardened texture to lung tissue w/ yellowish nodules troughout.

Applicant's summary and conclusion

Interpretation of results:

other: Not acute harmful.

Remarks:

According to Regulation (EC) No. 1272/2008 and its amendments.

Conclusions:

An LD50 of 3900 mg/kg bw was obtained in the acute oral toxicity study with rats. According to GHS the substance needs to be classified for acute oral toxicity category 5 and labelled with H103: May be harmful if swallowed.

Executive summary:

In an acute oral toxicity study 4 groups of 10 rats were orally exposed to 1730, 2470, 3510 and 5000 mg/kg bw of the substance. The rats were observed for signs of toxicity and pharmacological effects for a period of 5 days. Deaths occurred on day 0, 1, 2, 4 and 5. Lethargy was seen at all levels, other clinical signs were chromorhynorrhea, piloerection, ataxia, red exudate, ptosis, diarrhea, falccid muscle tone and anogenital.

Based on the results, an LD50 of 3900 mg/kg bw was obtained in the acute oral toxicity study with rats.