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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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: The reliability score is based on the study is similar to current OECD guideline 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 402 (Acute Dermal 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), no details on dermal exposure.

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:

rabbit

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

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

No details specified.

Duration of exposure:

No details.

Doses:

1250, 2500 and 5000 mg/kg bw

No. of animals per sex per dose:

Total of 4 (sex not 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:

3 500 mg/kg bw

Based on:

test mat.

95% CL:

2 200 - 5 700

Mortality:

See "any other information results"

Clinical signs:

other: At 2500 mg/kg bw lethargy was observed in one animal on day 1. All other animals showed no abnormalities at any dose level.

Gross pathology:

See "any other information results"

Other findings:

Irritation: See "any other information results"

Any other information on results incl. tables

Deaths per day after exposure to Bicyclononalactone

Dose mg/kg bw	Deaths/day	total
1250	0	0/4
2500	1/1	1/4
5000	2/1, 1/2	3/4

Skin irritation after exposure to Bicyclononalactone

Dose mg/kg bw	1250	2500	5000
Redness:
Slight		1/3 *	1/2 **
Moderate	4/4	2/3	1/2
Edema:
Slight	4/4	3/3	2/2

* 1 animal dead prior to reading

** 2 animals dead prior to reading

Necropsy observations after exposure to Bicyclononalactone

	No. of rats
Doses mg/kg bw	1250	2500	5000
Normal		2	1
Exudate, nose/mouth, yellow			1
Exudate, anogenital, brown		1	2
Intestines, areas red		1	3
Intestines, areas yellow			1
Intestines, bloated	3	1	3
Stomach, areas red			1
Liver dark	3	1
Liver mottled		1	3
Lungs dark			2
Lungs areas dark		1	1
Kidney dark	1		1
Kidney mottled	2
Skin edema			2
Skin redness			2
Intestines, contained green fluid			1
Liver white nodules			1
Gall bladder large		1
Kidney pale			1

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 3500 mg/kg bw was obtained in the acute dermal toxicity study with rabbits. According to GHS the substance needs to be classified for acute dermal toxicity category 5 and labelled with H313: May be harmful in contact with skin.

Executive summary:

In an acute dermal toxicity study 3 groups of 4 rabbits were dermally exposed to 1250, 2500 and 5000 mg/kg bw of Bicyclononalactone. The rabbits were observed for signs of toxicity and pharmacological effects for a period of 5 days. Deaths occurred on day 1 and 2. At 2500 mg/kg bw lethargy was observed in one animal on day 1 and one animal died. At 5000 mg/kg bw 3/4 animals died by day 2. Slight to moderate redness and slight edema was observed in all animals. Based on the results, an LD50 of 3500 mg/kg bw was obtained in the acute dermal toxicity study with rabbits.