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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

Test guideline
Qualifier:
no guideline available
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:
GHS criteria not met
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.