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:
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:
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

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals 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.


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