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Diss Factsheets

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
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:
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

Administration / exposure

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

Results and discussion

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.
Effect levels
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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.