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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
November 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Source study has reliablity 2. Details on the read across are attached in section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1980

Materials and methods

Principles of method if other than guideline:
Acute toxicity in rats assessed in limit test at dose of 5000 mg/kg by oral route. Observations were continued for up to 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Similar Substance 01
IUPAC Name:
Similar Substance 01
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5 % in water
Details on oral exposure:
Concentration in vehicle: 50 % m/v
Maximum volume applied: 10 ml/kg
Doses:
5000 mg/kg
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
Duration of observation period following administration: 14 days

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:
other: Brown urine

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
LD0 = 5000 mg/kg
LD50 > 5000 mg/kg
Executive summary:

Method

Test substance was administered to 5/rat/sex by gavage at dose of 5000 mg/kg. Test animals were observed for 14 days after dosing.

Results

No mortality was recorded, thus LD0 = 5000 mg/kg and LD50 > 5000 mg/kg.