Cyclohexadecen-1-one

Endpoint summary

Description of key information

Based on the results of an OECD 420 compliant study, the oral LD50 of the test item was found to be greater than 2000 mg/kg bw/d.

Based on the results of an OECD 402 compliant study, the dermal LD50 of the test item was found to be greater than 2000 mg/kg bw/d.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003-10-25

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

2001

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: not specified
- Weight at study initiation: 138 - 166 g
- Fasting period before study: overnight prior to dosing
- Housing: The rats were kept in transparent polycarbonate cages (macrolone type III, floor area 810 cm2) with two or three in each cage. The cages were cleaned and the bedding changed at least twice a week.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 +/- 3 °C
- Humidity: 55 +/- 15 %
- Air changes: 10 per hr
- Photoperiod: 12 / 12 hrs dark / hrs light

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

4 females (main study)
1 female (pre-test)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each rat was observed 30 min., 2, 4 and 6 hours after the administration and thereafter daily for a period of 14 consecutive days. Body weight was recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Preliminary study:

The animal included in the sighting study (animal No. 1) survived the treatment and showed slight signs of toxicosis. The rat had a normal body weight gain during the study period. It showed piloerection 30 min. after the application of the test item. After 2 and 4 hours a hunched posture and piloerection were observed, whereas the rat still showed only piloerection after 6 hours. From day 1 until the end of the observation period on day 14 the animal was free of any abnormalities. The post mortem inspection revealed no pathological abnormalities.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the female rats died on account of the treatment nor did they show marked signs of toxicosis.

Clinical signs:

other: Animals No. 2, No. 3, No. 4 and No. 5 showed a hunched posture and piloerection 30 min., 2 and 4 hours after the application of the test item. At animal No. 2 a tremor was additionally recorded after 4 hours. After 6 hours all four animals were marked wit

Gross pathology:

The gross necropsy of the animals revealed no pathological abnormalities.

Table 1 Body weight group mean values [g] – Main study

Dose mg/kg bw	sex	Day 0			Day 7			Day 14
2000	female	mean	SD	n	mean	SD	n	mean	SD	n
		143	5	4	178	8	4	200	5	4

 

Table 2 Daily Observations – Main study

Animal No

Dose mg/kg bw

sex

min

hours after dosing

Day after dosing

30

2

4

6

1

2

3

4

5

6

7

8-14

2

2000

Female

BE

BE

BEK

BEK

BE

A

A

A

A

A

A

A

3

2000

Female

BE

BE

BE

BEK

BE

A

A

A

A

A

A

A

4

2000

Female

BE

BE

BE

BEK

BE

A

A

A

A

A

A

A

5

2000

Female

BE

BE

BE

BEK

BE

A

A

A

A

A

A

A

 

Key to table 2

A Normal behaviour

B Piloerection

C Salivation

D Apathy

E Hunched posture/ abdominal rigidity

F Body weight loss or emaciation

G Vomitting

H Diarrhoea

I Constipation

J Compulsive behaviour/ Pruritus

K Tremor

L Paresis

M Discharge, abnormal

N Anaemia

O Blood around nose and eyes

P Dehydration

Q Dyspnea

R Cyanosis

S Ataxia

T Paralysis

U Comatose

V Moribund

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study, the LD50 of the test item was found to be greater than 2000 mg/kg bw/d.

Executive summary:

The acute oral toxicity in rats was determined according to the method recommended in the OECD Guideline No. 420, "Acute Oral Toxicity - Fixed Dose Procedure", December 2001. The study was initiated with a sighting study, in which one female rat was given the test item in a 2000 mg/kg b.w. dose. Slight signs of toxicosis were observed in this rat. Based on the results from the sighting study the main study was carried out with four more female animals each given a dose of 2000 mg/kg b.w. All animals in the main study survived the treatment and showed signs of toxicosis ranging from slight to moderate.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

GLP and guideline study.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

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

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

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

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

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

 

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

GLP and guideline study.

Additional information

Acute oral toxicity, OECD 420

The acute oral toxicity in rats was determined according to the method recommended in the OECD Guideline No. 420, "Acute Oral Toxicity - Fixed Dose Procedure", December 2001. The study was initiated with a sighting study, in which one female rat was given the test item in a 2000 mg/kg b.w. dose. Slight signs of toxicosis were observed in this rat. Based on the results from the sighting study the main study was carried out with four more female animals each given a dose of 2000 mg/kg b.w. All animals in the main study survived the treatment and showed signs of toxicosis ranging from slight to moderate.

Acute dermal toxicity, OECD 402

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.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data, the test item does not require classification as acutely toxic via the oral or dermal route according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.