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Diss Factsheets

Administrative data

Description of key information

- LD50 > 2000 mg/kg bw; acute oral toxicity study according to OECD TG 423, male and female Wistar rats, gavage, GLP, RL1

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:
1998-06-23 to 1998-07-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(adopted March 22, 1996)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
(September 1996)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 135-143 g (females), 163-181g (males)
- Housing: a maximum of five animals per cage (stainless steel cages, fitted with wire-screen floor and front)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 or 9 days
- Fasting period before study: overnight

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 54-87.5 (upper limit higher than 70%, because of meteorological circumstances and/or wet cleaning of the animal room)
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 /12
Route of administration:
oral: gavage
Vehicle:
maize oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw


Doses:
2000 mg/kg bw
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: Observations were made within 1 h and within 4h after dosing, and subsequently at least once daily throughout the observation period of 14 days. Body weight was recorded on day 0, and of the surviving animals on days 3, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, gross pathology
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One animal of each sex died before the end of the study period. Male no. 4 was found dead on day 4 after dosing,prior to dead the animal had shown sluggishness, blepharospasm, ataxia, encrustation eyes, piloerection, pallor, coldness and coma. Female no. 13 was found dead on day 1 after dosing, before death occurred this animal had shown sluggishness and ataxia.
Clinical signs:
other: The following signs were observed in the remaining surviving animals: Sluggishness occurred in male nos. 2 and 4 and in female no. 17 at 4 h after dosing and in female no.15 at 4 h and on days 3-5 after dosing. Hunching was observed in female no.15 on day
Gross pathology:
Examination at autopsy of the males and females did not reveal treatment-related gross alterations. The female found dead showed a fluid-filled stomach and intestines, while the male found dead showed a full bladder and clearly visible blood vessels, especially of the abdomen.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
1,4-Dioxane-2,5-dione (glycolide) was examined for acute oral toxicity in an experiment according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method) with 3 male and 3 female rats (limit testing with 2000 mg/kg bw). One male and one female died during the 14-day observation period. Thus, the LD50 of 1,4-dioxane-2,5-dione (Glycolide) in male and female rats is considered to exceed 2000 mg/kg bw. However, clinical signs of toxicity other than diarrhoea, piloerection or an ungroomed appearance were observed in the remaining animals, thus, the test item is classified as " may be harmful if swallowed" (Category 5) according to GHS criteria.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
Guideline study without deviations; RL1; 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

1,4-Dioxane-2,5-dione (glycolide) was examined for acute oral toxicity in an experiment according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method) with 3 male and 3 female rats (limit testing with 2000 mg/kg bw). One male and one female died during the 14-day observation period. Prior to death the animals showed sluggishness and ataxia, the male found dead also exhibits blepharospasm, encrustation eyes, piloerection , pallor, coldness and coma. These clinical signs were also observed in the remaining animals. No treatment related effects on body weight or macroscopical findings were observed. Hence, the oral LD50 of 1,4 -dioxane-2,5 -dione was considered to exceed 2000 mg/kg bw. However, clinical signs of toxicity other than diarrhoea, piloerection or an ungroomed appearance were observed in the remaining animals, thus, the test item is classified  as " may be harmful if swallowed" (Category 5) according to GHS criteria.

Justification for classification or non-classification

Based on the available data, 1,4 -dioxane-2,5 -dione is classified as "may be harmful if swallowed" (Category 5) according to GHS criteria and has no obligatory labelling requirement for acute oral toxicity according to Regulation (EC) No 1272/2008 (CLP).