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Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity (rat): LD50 > 2000 mg/kg.

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:
26 May to 29 August 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted in accordance with internationally recognised guidelines
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Acute oral toxicity (2-1-1), 12 Nousan No 8147, Agricultural Production Bureau, November 24, 2000.
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
other: RccHan®:WIST albino rats
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: reputable supplier
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: 152 to 173 g
- Housing: singly for sighting investigations and in groups of four rats of the same sex for the main study..
- Diet: free access to standard rodent diet except for overnight prior to and approximately four hours after dosing.
- Water: free access to water from the public supply
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 40 to 70%
- Air changes (per hr): continuous supply inder positve pressure
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours continuous dark per 24 hours

IN-LIFE DATES: From: 28 May To: 23 June 2015
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg body weight

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight

Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
1 - sighting investigation
4 - main study
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: the macroscopic appearance of the brain, caecum,
duodenum, heart, kidneys, small and large intestine, liver, lungs and bronchi, spleen, stomach, subcutaneous tissue and urinary bladder was recorded
Preliminary study:
No deaths or clinical signs. Satisfactory bodyweight gain. No abnormalities observed during macrospopic examination
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths during the study.
Clinical signs:
Piloerection was seen in one female dosed at 2000 mg/kg. This sign was first noted on Day 2. Recovery, as judged by external appearance and behaviour, was complete by the end of Day 2. No clinical signs were seen for any other animal.
Body weight:
All animals were considered to have achieved satisfactory body weight gains throughout the study.
Gross pathology:
No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute median lethal oral dose (LD50) to rats of Aliphaticdiol diglycidyl ether was demonstrated to be greater than 2000 mg/kg body weight.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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

An acute oral toxicity study was conducted (HLS, 2015) to assess the effect of Aliphaticdiol diglycidyl ether following a single oral administration of the test substance to rats. The study was conducted in compliance with GLP and according to EC and OECD test guidelines. Rats were dosed according to the acute toxic class method, and were observed for 14 days after administration. The highest dose level assessed was 2000 mg/kg; no deaths were observed at this level and no signs of toxicity were found. The acute median lethal dose (LD50) to rats was found to be greater than 2000 mg/kg body weight.

Justification for selection of acute toxicity – oral endpoint

A reliable study (GLP-compliant study conducted according to official international test guidelines) is available; the available result is considered satisfactory to meet the data requirement for this endpoint.

Justification for classification or non-classification

The acute LD50 by oral administration to rats for Aliphaticdiol diglycidyl ether was found to be greater than 2000 mg/kg; the substance does not meet the criteria for classification as acutely toxic by oral administration (CLP Regulation criteria).

No signs of toxicity were observed in the acute oral toxicity test; there is therefore no indication of specific target organ toxicity.