Reaction products of diphenyl ether and 9-methylene nonadecane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of diphenyl ether and 9-methylene nonadecane

EC Number:

943-303-1

Molecular formula:

Variable, substance is a UVCB

IUPAC Name:

Reaction products of diphenyl ether and 9-methylene nonadecane

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Orient Bio Co. Ltd.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 9 to 10 weeks
- Weight at study initiation: 185 to 225 g
- Fasting period before study: Fasted overnight (18 hours)
- Housing: Stainless steel wire cage (less than 3 animals per cage)
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Animals were allocated an acclimitisation period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.9 to 23.2
- Humidity (%): 51.9 to 61.4
- Air changes (per hr): 10 to 20
- Photoperiod (hrs dark / hrs light): 12 hour light 12 hour dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 or 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg BW
- Justification for choice of vehicle:Standard vehicle
- Lot/batch no. (if required):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No information on the potential toxicity of the test substance was available so a standard approach of initially dosing 300 mg/kg BW followed by a dose of 2000 mg/kg BW was followed.

Doses:

300 or 2000 mg/kg BW

No. of animals per sex per dose:

6 per sex per dose (females were dosed three at a time with an appropriate lag time before dosing the second set of animals).

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0.5, 1, 2, 3 and 4 hours after dosing and then once daily for 14 days (clinical signs) and on days 1, 3, 7 and 14 (weighing).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weights.

Statistics:

No statistical analysis was performed on study. This is not a requirement of the testing guideline.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There we no unscheduled deaths on study

Clinical signs:

other: Clinical signs were limited to transient soft stool and diarrhoea observed in a low number of animals.

Gross pathology:

No abnormal gross findings.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight. Accordingly no classification for acute oral toxicity effects are warranted.