Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: the study was performed before GLP- and OECD-testing guidelines were available and in force; therefore the study was considered to have Klimisch 2, however it provides enough information to assess the acute toxicity to rats after oral application
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2-dimethyl-1,3-dioxane-4,6-dione
EC Number:
217-992-8
EC Name:
2,2-dimethyl-1,3-dioxane-4,6-dione
Cas Number:
2033-24-1
Molecular formula:
C6H8O4
IUPAC Name:
2,2-dimethyl-1,3-dioxane-4,6-dione
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): P5096
- Physical state: crystalline powder
- Analytical purity: 97.6%
- Purity test date: 28-Nov-1979
- Lot/batch No.: no data
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Bantin and Kingman Ltd., Grimston, Aldbrough, Nr. Hull, UK
- Age at study initiation: no data
- Weight at study initiation: 125 - 225 g
- Diet (e.g. ad libitum): Food (Rat and Mouse No. 1 Expanded Diet SQC, BP Nutrition (U.K.) Ltd., Stepfield, Witham, Essex).
- Water (e.g. ad libitum): Mains water was provided and dipensed from glass water bottles
- Acclimation period: 6 days
- Fasting period: overnight fast (for 18 - 20 hours before treatment)
- Housing: Caged in groups of 2 or 5 as appropriate in solid-bottomed plastic cages furnished with softwood sawdust which was replaced twice each week.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 40-60%
- Air changes (per hr): air-conditioned room
- Photoperiod (hrs dark / hrs light): fluorescent lighting during working hours (08.45 - 17.00)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE:
- Concentration in vehicle:
Group 1 - 250 mg/kg: 25 mg/ml
Group 2 - 500 mg/kg: 50 mg/ml
Group 3 - 1000 mg/kg: 100 mg/ml
Group 4 - 2000 mg/kg: 200 mg/ml
Group 5 - 5000 mg/kg: 500 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg

DOSAGE PREPARATION:
Suspensions of the test article were prepared in 1% methyl cellulose
Doses:
Dose levels of 250, 500, 1000, 2000 (DRF) and 5000 mg/kg (main study) were tested.
No. of animals per sex per dose:
Four groups each of 4 fasted rats (2 males, 2 females) and 1 group of 10 fasted rats (5 males, 5 females) were dosed according to the following scheme:

RANGE-FINDING:
Group 1 - 250 mg/kg: 2 males / 2 females
Group 2 - 500 mg/kg: 2 males / 2 females
Group 3 - 1000 mg/kg: 2 males / 2 females
Group 4 - 2000 mg/kg: 2 males / 2 females

MAIN STUDY:
Group 5 - 5000 mg/kg: 5 males / 5 females
Control animals:
no
Details on study design:
OBSERVATION:
Duration of observation period following administration: 14 days

FREQUENCY OF OBSERVATIONS AND WEIGHING:
Dose range-finding study: mortalities recorded during the 48 hours following treatment.
Main group: appearance, behaviour and general observations were observed for overt signs of toxicity or behavioural change at 1/4, 1, 2 and 4 hours after treatment and subsequently once daily for 14 days.

BODY WEIGHTS:
Body weight: Individual body weights were recorded on the day before treatment, on the day of treatment and 7 and 14 days after treatment.

NECROPSY:
Any animal that died during working hours or was killed in extremis or appeared sick at the end of the observation period was subjected to a gross necropsy examination. Animals surviving at the end of the study were killed by exposure to high levels of carbon dioxide.

Results and discussion

Preliminary study:
A dose-range finding study was conducted with dose levels of 250, 500, 1000 and 2000 mg/kg
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
Dose range-finding study (250-2000 mg/kg):
No deaths were noted at the end of the 48 hour observation period

Main study (5000 mg/kg):
No deaths were noted at the end of the 48 hour observation period
Clinical signs:
other: All animals appeared normal during the observation period
Gross pathology:
No necropsies were performed

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral toxicity on Albino rats was determined to be > 5000 mg/kg for males and females.
Executive summary:

A study was carried out equivalent or similar to EU Method B.1 and OECD Guideline 401 (Acute Oral Toxicity) on Albino Wistar rats. 4 groups of 4 rats (2 male, 2 female) for Dose-Range-Finding and 1 group of 10 rats (5 male, 5 female) for the main study were treated by gavage with doses from 250 up to 5000 mg/kg. Neither mortality nor clinical signs were noted in any of the dose groups. Animals showed normal body weight gains at the end of the 14 d observation period. Necropsy was not performed. The LD50 was determined to be > 5000 mg/kg for both sexes.