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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
Guideline not mentioned, but details given sugest that study follows the guideline requirements
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Reaction product of tetrahydro-2,5-dimethoxy furan, ethanol and water
EC Number:
947-436-6
Molecular formula:
not applicable for UVCB
IUPAC Name:
Reaction product of tetrahydro-2,5-dimethoxy furan, ethanol and water
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: BOR: WISW
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann Versuchstierzucht, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: not reported
- Weight at study initiation: Male: 160.8-196.3 g, female: 150.0-184.2 g
- Fasting period before study: 16 h
- Housing: in groups
- Diet (e.g. ad libitum): ad libitum Ssniff-R Alleindiät für Ratten
- Water (e.g. ad libitum) :ad libitum
- Acclimation period: at least 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 2
- Humidity (%): 50-85
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10% in water
Doses:
1.5, 1.75, 2.0, 2.25 and 2.5 g/kg
based on range finding results
No. of animals per sex per dose:
5m/5f
Control animals:
yes
Statistics:
LD50 calculated with Probit analysis accoridng to Finney 1971

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 140 mg/kg bw
Based on:
test mat.
95% CL:
> 1 910 - < 2 160
Remarks on result:
other: value after 2 d
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 140 mg/kg bw
Based on:
test mat.
95% CL:
> 2 010 - < 2 390
Remarks on result:
other: valkue after 1 d
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 991 mg/kg bw
Based on:
test mat.
95% CL:
> 1 880 - < 2 123
Remarks on result:
other: value after 3/14 d
Mortality:
10% after 48 h in males and females at 2.5 g/kg
Clinical signs:
Apathy, convulsions and influence on coordination increased with increasing dose and was observed up to 3 d after treatment. During recovery no effects were observed and all surviving animlas showed a normal behaviour.
Body weight:
No effects on body weight gain.
Gross pathology:
slight to moderate hemorraghe in stomach/gut mucosa

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based on the effects observed after 1d, 2d and 3/14d, the LD50 after oral exposure is >2000 mg/kg. However, the calculated value after 3/14d is slightly below the threshold with 1990 mg/kg. This value will be used for classification and labelling.