1-methyl-4-piperidyl diphenylglycolate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

See executive summary.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

1-methyl-4-piperidyl diphenylglycolate has to be classified as „Acute toxicity-oral“ in Category 4.

Executive summary:

Normally a test for the determination of the endpoint „ Acute Toxicity, oral” (e.g. acc. to EU-methods B.1-bis (OECD420) or B.1-tris (OECD423) would be required.
An adaption of the standard testing regime is possible (e. g. by “data waiving”), if the test does not appear scientifically necessary and other information are available.

Data from old, experimental studies are available. The “Acute Toxicity, oral” was tested with a experimental study in 1981 by the “Center for product toxicology of chemical industry Graupa [Zentralstelle für Produktentoxikologie der Chemischen Industrie Graupa]” in a conventional, classic test. This test was in accordance with national standard methods with acceptable restrictions and therefore with a reliability value of 2. This center of product toxicology was the only legal place in the former GDR for such tests (legal-controlled with compliance of international regulations, e.g. principles of the later OECD401).

Report Determination of Acute Toxicity, oral of Benzilic acid-N-methylpiperidinyl-(4)-ester (P0-base); [10. 07. 1981]
- Data source:
- Date of report: 10. 07. 1981
- Authors: I. Frosch; K. Stade
- Year: 1981
- Testing laboratory: Zentralstelle für Produktentoxikologie der Chemischen Industrie Graupa
- Company owner: VEB Apogepha Dresden
- Language: German
- Materials and methods
- test guideline: not explicitly stated; classic method in accordance to OECD401
- Test material:batch161179; in-house monography Apogepha (assay > 98 %; purity by TLC with benzylic acid and benzylic acid methyl ester and 1-methyl-4-hydroxy-piperidine nmt. 0.1 %; loss on drying nmt. 1 % etc.); test date unknown;
- Storage: room temperature
- Test animals:
- Species: rat; strain Wistar (VEB Versuchstierproduktion Schönwalde)
- Sex: male/female; average weight male 167 +/- 10 g; female 170 +/-14 g; housing with max. 10 animals in one cage at 22 +/- 2 ° C; food standard pellets formulation R/3 ad libitum; water ad libitum
- Administration/exploration
- Route of administration: oral with gavage; as 20 % solution in 0.5 % aqueous Tylose solution
- Time of administration 1 week; January 1981
- Pretest: 15 female
- Full-test: 30 male and 30 female
- Doses: male: 1250 mg/kg and 1500 mg/kg and 1750 mg/kg
- Doses female: 1000 mg/kg and 1250 mg/kg and 1500 mg/kg
- No. of animals per sex and dose: 10
- Control animals: no
-Evaluation and poisoning symptoms:
after application and after 0.5 h, 2 h, 6 h, 24 h, and 48 h with symptoms, like ataxie, exophthalmos, bloody saliva, cramps; piloerection, Righting-refllex etc.; Evaluation with “probit-regression analysis”

 

 

Mortality

Dose mg/kg	Sex	No: of animals	No. of died animals after
			24 h	48 h	7 d
1000	female	10	2	2	2
1250	female	10	5	5	5
1500	female	10	7	9	9
1250	male	10	3	4	4
1500	male	10	4	4	5
1750	male	10	7	8	9

Effect level, based on test material:
- male 24 h LD50 = 1527 mg/kg (1308-1783 mg/kg)
- female 24 h LD50 = 1273 mg/kg (1104-1468 mg/kg)

This old results of the study is reliable with restrictions (Klimisch-code of 2) and therefore certain, consistent and safe to avoid additional animal testing. They can be used for CLP classification and risk assessment.

Conclusion:
1-methyl-4-piperidyl diphenylglycolate “ has to be classified in the Hazard Class „Acute toxicity-oral“ in Category 4 with „H302: Harmful if swallowed”.