Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From November 19, 1982 to December 7,1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
The complete read across justification is detailed in section 13. Source study has reliability 2.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
Version / remarks:
1978
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, 4414 Fuellinsdorf/Switzerland
- Age at study initiation: male, 7 weeks; female, 9 weeks
- Weight at study initiation: male, 211-252 g, female 168-187 g
- Housing: animals were caged in group of 5 in Macrolon cages type 3 with wire mesh tops and standardised granulated soft wood bedding
- Diet: pelleted standard kliba 23/341/1, rabbit maintenance diet defined for acceptable contaminant level, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hours cycle dark/light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE 2 % solution of CMC(carboxymethylcellulose natrium salt purum) in distilled water:
- 10 ml at 1000 mg/kg bw
- 20 ml at 5000 mg/kg bw
Doses:
1000, 5000 mg/kg bw
No. of animals per sex per dose:
5 per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations:
1. bodyweights: at day of administration and day 7 and 14 after administration;
2. mortality: 5 times during the first day and daily thereafter;
3. symptoms on general behaviour, respiration, eye, nose, motility, body position, motor susceptibility, skin: 5 times at day 1 and then daily for the nature, onset, severity and duration of all gross or visible toxic or pharmacological effects as well as rate and time of death.
- Necropsy of survivors performed: yes
Statistics:
The logit model could not be applied to the observed rates of death. The LD50 was calculated without use of a statistical model by estimation.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
ca. 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None.
Clinical signs:
At the dose of 1000 mg/kg bw only ruffled fur was noted in male and female rats. This symptom disappeared within 14-day observation period.
At the dose of 5000 mg/kg bw dyspnoea, curved body position and ruffled fur were noted in male and female rats. These symptoms disappeared within 14-day observation period.
Gross pathology:
No pathological changes.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP Regulation (EC n. 1272/2008)
Conclusions:
The acute oral LD50 in rats of both sexes observed over period of 14 days was estimeted to be greater than 5000 mg/kg bw.
Executive summary:

Method

Acute oral toxicity study in rats administered at doses of 1000 and 5000 mg/kg bw. 5 animals per sex per dose were used and observed for 14 days after dosing.

Results

The following death rate was observed:

0 % at 1000 mg/kg

0 % at 5000 mg/kg

The acute oral LD50 in rats of both sexes observed over period of 14 days was greater than 5000 mg/kg bw.