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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Analogue substance tested.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method

Test material

Constituent 1
Reference substance name:
Analogue substance (refer to IUCLID chapter 13)
IUPAC Name:
Analogue substance (refer to IUCLID chapter 13)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 2 % solution of CMC in distilled water
Doses:
Application Volume/kg body weight:
Group 1: 10 ml at 1000 mg/kg
Group 2: 20 ml at 5000 mg/kg
Group 3: 20 ml at 8000 mg/kg
No. of animals per sex per dose:
Number of animals per group/per dose: 5 males, 5 females
Total number of animals: 15 males, 15 females
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 028 mg/kg bw
Clinical signs:
other: The following symptoms were observed: 1000 mg/kg: dyspnea 5000 mg/kg: sedation, dyspnea, ataxia, curved body position, ruffled fur, extremities bluish discolored 8000 mg/kg: sedation, dyspnea, ataxia, ventral body position, latero-abdominal body position,

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information
Conclusions:
The acute oral toxicity test was carried out with the analogue substance. Based on the results of the test, the LD50 of the analogue substance in rats of both sexes observed for a period of 15 days is 4028 mg/kg. Due to the structural similarity of the analogue substance and the substance subject of registration it can be derived that LD50 for the substance subject to registration will be > 2000 mg/kg.