1-Decene, 1-ethoxy-

Endpoint summary

Description of key information

Acute oral toxicity, OECD TG 423: LD50 > 2500 mg/kg bw.  

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:

Between 27 September 2001 and 16 October 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols and under GLP conditions.

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

other: Sprague-Dawley CD (Crl: CD® (SD) IGS BR)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: A reputable supplier UK
- Age at study initiation: Approximately eight weeks of age.
- Weight at study initiation: At least 200g
- Fasting period before study: Overnight fast immediately before dosing
- Housing: Housed in groups of three by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): Free access to food (Certified Rat and Mouse Diet (Code 5LF2)
- Water: Free access to mains drinking water
- Acclimation period: At least five days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25°C
- Humidity: 30 to 70%
- Air changes (per hr): At least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

For the purpose of the study the test material was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level.
Specific gravity = 0.768, dose volume 2.61 ml/kg.

Doses:

2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 30 Min, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment.
- Necropsy of survivors performed: At the end of the observation period the animals were killed by cervical dislocation.
All animals were subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs.
The appearance of any macroscopic abnormalities was recorded.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: There were no signs of systemic toxicity.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

None

Table 1          Mortality 

Dose Level mg/kg	Sex	Number of Animals Treated	Deaths During Day of Dosing (Hour)				Deaths During Period After Dosing (Days)								Deaths
			½	1	2	4	1	2	3	4	5	6	7	8-14
2000	Female	3	0	0	0	0	0	0	0	0	0	0	0	0	0/3
	Male	3	0	0	0	0	0	0	0	0	0	0	0	0	0/3

 

Table 2          Individual Clinical Observations 

Dose Level mg/kg	Animal Number and Sex	Effects Noted After Dosing (Hours)				Effects Noted During Period After Dosing (Days)
		½	1	2	4	1	2	3	4	5	6	7	8	9	10	11	12	13	14
2000	1-0 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	1-1 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	1-2 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2-0 Male	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2-1 Male	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2-2 Male	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

 

Table 3          Individual Bodyweights and Weekly Bodyweight Changes

Dose Level mg/kg	Animal Number and Sex	Bodyweight (g) at Day			Bodyweight Gain (g) During Week
		0	7	14	1	2
2000	1-0 Female	215	228	241	13	13
	1-1 Female	226	248	262	22	14
	1-2 Female	217	245	256	28	11
	2-0 Male	227	298	342	71	44
	2-1 Male	230	303	350	73	47
	2-2 Male	225	307	350	82	43

 

Table 4          Individual Necropsy Findings

Dose Level mg/kg	Animal Number and Sex	Macroscpoic Observations
2000	1-0 Female	No abnormalities detected
	1-1 Female	No abnormalities detected
	1-2 Female	No abnormalities detected
	2-0 Male	No abnormalities detected
	2-1 Male	No abnormalities detected
	2-2 Male	No abnormalities detected

 

Interpretation of results:

other: The test material does not meet the criteria for classification

Remarks:

Criteria used for interpretation of results: other: EU labelling regulations Commission Directive 93/21/EEC.

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Crl:CD® (SD) IGS BR) strain rat was estimated as being greater than 2500 mg/kg bodyweight.

Executive summary:

A study according to OECD 423 was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD (Crl: CD® (SD) IGS BR) strain rat. A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a group of three fasted animals of the other sex at the same dose level. The test material was administered orally undiluted. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Cri: CD® (SD) IGS BR) strain rat was estimated as being greater than 2500 mg/kg bodyweight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The one acute oral toxicity study available is of sufficient quality for the present dossier.

Additional information

A study according to OECD 423 was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD (Crl: CD® (SD) IGS BR) strain rat. A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a group of three fasted animals of the other sex at the same dose level. The test material was administered orally undiluted. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Cri: CD® (SD) IGS BR) strain rat was estimated as being greater than 2500 mg/kg bodyweight.

Justification for selection of acute toxicity – oral endpoint
The result of the study is reliable and adequate for covering the endpoint.

Justification for classification or non-classification

Arctical does not have to be classified and labelled for acute oral toxicity in accordance with Regulation (EC) No. 1272/2008 and Directive 67/548/EEC.