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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
21 Sep - 05 Oct 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

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:
yes

Test material

Constituent 1

Test animals

Species:
rat
Strain:
other: Tif:RAif (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 7 to 8 weeks
- Body weights at study initiation: males - 175 g; females - 176 g
- Fasting period before study: overnight
- Housing: in groups of 5 in Macrolon cages (type 3)
- Diet: rat food NAFAG No. 890 NAFAG Gossau SG, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hours light per day

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
400
Details on oral exposure:
VEHICLE
- Amount of vehicle: 20 mL/kg body weight
Doses:
5000 mg/kg body weight
No. of animals per sex per dose:
5 animals/sex
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: physical condition and rate of deaths were monitored throughout the whole observation period; body-weights were recorded immediately prior to dosing (control weights) and at 7 and 14 days
- Necropsy of survivors performed: yes; all animals were submitted to a necropsy, whenever they died, survivors at the end of the observation period
- Other examinations performed: gross examination

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occured.
Clinical signs:
Dyspnoea, exophthalmos, ruffled fur reported, diarrhoea and curved body position were observed. Nevertheless all symptoms are recovered within 9 days.
Body weight:
No significant differences reported.
Gross pathology:
No compound related gross organs changes were reported.

Any other information on results incl. tables

Signs and symptoms hrs Days
1 2 3 5 24 2 3 4 5 6 7 8 9 10 11 12 13 14
Sedation
Dyspnoea + + + + + + + + + + + +
Dacryorrhoea
Chromodacryorrhoea
Rinorrhoea
Epistaxis
Exophthalmos + + + + + + +
Salivation
Ruffled fur ++ ++ ++ ++ + + + + + + +
Pallor
Cyanosis
Diarrhoea + +
Body position (ventral)
Body position (lateral)
Body position (curved) + + + + + + + + + +
Ataxia
Trismus
Tremor
Tonic clonic muscle spasms
Convulsions

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Executive summary:

Method

The acute oral toxicity of the test compound in rats of both sexes was tested at the single concentration of 5000 mg/kg bw and observed over a period of 14 days.

Results

The LD50 is greater than 5000 mg/kg bw.