1-(vinyloxy)dodecane

Endpoint summary

Description of key information

An acute oral LD50 was determined to be > 2000 mg/kg bw in rats. 

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:

2015-11-02 to 2015-11-26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Experimental study according to guideline and GLP

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

2002

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nosan No. 8147

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bioassay Labor für biologische Analytik GmbH, 69120 Heidelberg

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 180 - 188 g
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Single, Makrolon cage type III
- Diet: ad libitum, VRF1(P) from SDS Special Diets Services, 67122 Altrip, Germany
- Water: ad libitum, tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3
- Humidity (%): 30 – 70
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

A single application of undiluted test substance was done.

CLASS METHOD
- Rationale for the selection of the starting dose: By request of the sponsor a starting dose of 2000 mg/kg bw was chosen in the first step with 3 female animals. Because no mortality occurred, 2000 mg/kg bw were administered to another group of 3 female animals in the second step.

Doses:

2000 mg/kg bw
Volume: 2.46 mL/kg bw

No. of animals per sex per dose:

6 in two groups

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation. Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Calculations were performed using Microsoft Excel 2003 and checked with a calculator.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

No clinical signs were observed during clinical examination.

Body weight:

The body weights of the animals increased within the normal range throughout the study period with one exception in the first 2000 mg/kg bw test group. This animal showed a normal increase of body weight during the first week, but revealed a marginal loss of body weight during the second week. As the affected animal showed neither clinical signs nor a change in behavior during the second observation week, the observed marginal loss of body weight was considered to be unspecific.

Gross pathology:

There were no macroscopic pathological findings in all animals.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

Experimental study according to guideline and GLP.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute toxicity

Oral

An acute oral toxicity study with the test substance was conducted in rats according to OECD TG 423. Female animals (6) received 2000 mg/kg bw one time via gavage and were observed for 14 days. No mortality occurred and no clinical signs and pathological changes were observed. The body weights of the animals increased within the normal range throughout the study period with one exception in the first 2000 mg/kg bw test group. This animal showed a normal increase of body weight during the first week, but revealed a marginal loss of body weight during the second week. As the affected animal showed neither clinical signs nor a change in behavior during the second observation week, the observed marginal loss of body weight was considered to be unspecific. Due to those observations the acute oral LD50 was determined to be > 2000 mg/kg bw in rats. Therefore the test substance is considered to be not classified for acute oral toxicity according to CLP. 

Justification for selection of acute toxicity – oral endpoint
The study is considered reliable.

Justification for classification or non-classification

Acute oral toxicity

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008, as amended for the seventh time in Regulation (EC) No 2015/1221. As a result the substance is considered to be not classified for acute oral toxicity.