Cyclohexadecen-1-one

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-07-26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

448-300-4

EC Name:

-

Cas Number:

88642-03-9

Molecular formula:

C16H28O

IUPAC Name:

(6E)-cyclohexadec-6-en-1-one; (7Z)-cyclohexadec-7-en-1-one; (8E)-cyclohexadec-8-en-1-one; (8Z)-cyclohexadec-8-en-1-one

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: Males 52 days; females 63 days
- Weight at study initiation: Males 228 - 253 g; females 200 - 219 g
- Fasting period before study: not specified
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3 °C
- Humidity: 55 +/- 15 %
- Photoperiod: 12 hrs dark / hrs light

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: sesame oil

Details on dermal exposure:

TEST SITE
- Area of exposure: animal´s back between the fore and the hind extremities
- % coverage: approx. 1/10 of body surface
- Type of wrap: 8 layers of gauze covered with a plastic sheet and secured with adhesive plaster

REMOVAL OF TEST SUBSTANCE
- Washing: not applicable

TEST MATERIAL
- Amount applied: 10 mL/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males, 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before and immediately, 5, 15, 30 and 60 min as well as 3, 6 and 24 hours after administration. All surviving animals were observed for a period of 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical signs observed.

Gross pathology:

No macroscopical changes were noted at necropsy.

Other findings:

- Organ weights: not examined
- Histopathology: not examined

Any other information on results incl. tables

Table 1 Summarized Results: 2000 mg test item / kg bw

Symptoms/Criteria	Males (n=5)	Females (n=5)
Clinical signs	none	None
Skin reactions	none	None
Mortality Within 6 h Within 24 h Within 7 d Within 14 d	0 0 0 0	0 0 0 0
Mean body weight (in g)
Start	239.6	207.0
After 7 days	295.2 (+23.1)	253.2 (+12.6)
After 14 days	360.0 (+50.1)	248.6 (+20.1)
Inhibition of body weight gain	None	None
Necropsy findings	None	None

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study the test item revealed a dermal LD50 of > 2000 mg/kg bw in the rat.

Executive summary:

Acute dermal toxicity of the test item was assessed according to OECD TG 402. A single dermal administration of 2000 mg test item / kg bw to 5 male and 5 female rats did not reveal any clinical signs of toxicity nor mortality. No skin reactions were observed. The animals gained the expected weight throughout the whole study period. Therefore, the acute dermal LD50 was determined to be > 2000 mg/kg bw.