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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.