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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
study conducted on the analogue substance; The Reliability of the Source Study is 2.
Justification for type of information:
The read across justification is detailed in section 13.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
10 male Wistar rats/ group received single doses of the test item by gavage and were observed for clinical signs and mortality for 14 days standard acute method
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Similar Substance 01
IUPAC Name:
Similar Substance 01

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 180-200 g
- Housing: 5 per cage

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
10 male Wistar rats/ group received single doses by gavage and were observed for clinical signs and mortality for 14 days.
Doses:
3100, 5000 mg/kg bw
No. of animals per sex per dose:
10 males/group
Control animals:
no
Details on study design:
10 male Wistar rats/ group received single doses by gavage and were observed for clinical signs and mortality for 14 days.
Statistics:
no data

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: In the 5000 mg group 4/10 animals died: sedation and poor general condition
Mortality:
No animal died in the 3100 mg/kg bw group.
4/10 animals died within 2 to 6 days in the 5000 mg/kg bw group.
Clinical signs:
3100 mg/kg bw animals tolerated treatment without impairment
5000 mg/kg bw 10 /10: sedation, poor general condition
Body weight:
no details
Gross pathology:
no details

Applicant's summary and conclusion

Interpretation of results:
other: not classified as toxic or harmful according to the CLP Regulation (EC) No. 1272/2008
Conclusions:
The LD50 (oral) was found to be be greater than 5000 mg/kg bw.
Executive summary:

Groups of 10 male Wistar rats received single oral doses (3100 or 5000 mg/kg bw) of the test item dissolved in water and were observed for 14 days. Rats dosed with 3100 mg/kg bw tolerated the treatment without clinical signs or mortality. All 10 rats dosed with 5000 mg/kg bw showed sedation and poor general condition within 2 to 6 days after application of the test item, 4/10 died.

Therefore, the LD50 (oral) is > 5000 mg/kg bw.