Registration Dossier

Administrative data

Endpoint:
toxicity to microorganisms
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Principles of method if other than guideline:
Method: DIN 38412, Teil 8
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: as prescribed by 1.1 - 1.4

Substance-No.: SAT 020874
Batch-No.: Ro 3962-88

Sampling and analysis

Analytical monitoring:
not specified

Test solutions

Vehicle:
not specified

Test organisms

Test organisms (species):
Pseudomonas putida

Study design

Test type:
static
Water media type:
not specified
Limit test:
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
16 h
Dose descriptor:
EC10
Effect conc.:
4 mg/L
Duration:
16 h
Dose descriptor:
EC50
Effect conc.:
11 mg/L

Any other information on results incl. tables

RS-Freetext:
16h-EC10 =  4 mg/L (95%-CI: 2,8 - 5,O mg/L)
16h-EC50 = 11 mg/L (95%-CI: 10 - 14 mg/L)

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Executive summary:

Ro 1525 was tested according to Method: DIN 38412, Teil 8 and reached after 16 hours an EC50 of 11 mg/l related to active substance.