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Diss Factsheets

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

Constituent 1
Chemical structure
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.