Registration Dossier

Administrative data

Endpoint:
toxicity to other aquatic vertebrates
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
Although conducted using a method equivalent to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test), no analytical monitoring of test concentrations was conducted and there are deficiencies in the reporting compared to requirements of the modern OECD 203 Guideline. However, for the purpose of assessment of aquatic toxicity, this study will be used in a weight-of-evidence approach in conjunction with data on fish, aquatic invertebrates and aquatic algae for the puspoe of PNEC determination.

Data source

Reference
Reference Type:
publication
Title:
Toxicity of Mixtures of Heavy Metals and Petrochemicals to Xenopus laevis.
Author:
de Zwart, D. and Sloof, W.
Year:
1987
Bibliographic source:
Bull. Environ. Contam. Toxicol. 38:345-351.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: OECD Guideline 202: Daphnia sp. Acute Immobilisation Test. 23 November 2004.
Deviations:
yes
Remarks:
The study was conducted on the larvae of the clawed toad Xenopus laevis
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test item was of analytical grade.

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Xenopus laevis
Details on test organisms:
TEST ORGANISM
- Common name: Clawed toad
- Strain: Not applicable
- Source: Not reported
- Age at study initiation (mean and range, SD): 3-4 weeks
- Weight at study initiation (mean and range, SD): Not applicable
- Method of breeding: Not reported
- Length at study initiation (length definition, mean, range and SD): Not applicable
- Feeding during test: No
- Food type: Not reported
- Amount: Not reported
- Frequency: Not reported

ACCLIMATION
Not reported

QUARANTINE (wild caught)
Not reported

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: Not reported

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
None

Test conditions

Hardness:
Not reported
Test temperature:
The test was conducted at 20 ± 1 °C.
pH:
Not reported
Dissolved oxygen:
Not reported
Salinity:
Not reported
Nominal and measured concentrations:
The test was performed with 5 concentrations having factorial differneces of 1.5. The actual concentrations tested was not reported.
Details on test conditions:
TEST SYSTEM
- Test vessel: 1L all glass aquaria
- Material, size, headspace, fill volume: Not reported
- Aeration: Not reported
- Type of flow-through (e.g. peristaltic or proportional diluter): Not applicable
- Renewal rate of test solution (frequency/flow rate): Not applicable
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): Not reported
- No. of vessels per vehicle control (replicates): Not applicable
- Biomass loading rate: Not reported

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dutch Standard Water
- Total organic carbon: Not reported
- Particulate matter: Not reported
- Metals: Not reported
- Pesticides: Not reported
- Chlorine: Not reported
- Alkalinity: Not reported
- Ca/mg ratio: Not reported
- Conductivity: Not reported
- Culture medium different from test medium: Not reported
- Intervals of water quality measurement: Not reported

OTHER TEST CONDITIONS
- Adjustment of pH: Not reported
- Photoperiod: Not reported
- Light intensity: Not reported

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.5
- Justification for using less concentrations than requested by guideline: Not applicable
- Range finding study: Not reported
- Test concentrations: Not reported
- Results used to determine the conditions for the definitive study: Not reported
Reference substance (positive control):
no

Results and discussion

Effect concentrations
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
12.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
No further details reported.
Results with reference substance (positive control):
Not applicable.
Reported statistics and error estimates:
Toxicity is expressed in mg/L as the medial lethal concentration after 48 hours (48-h LC50) which was calculated as a projection from the least square linear regression on log transformed nominal concentrations data and probit transformed per cent effect data.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 48-h LC50 of allylamine to the larvae of X. laevis was 12.4 mg/L.
Executive summary:

The acute toxicity of monoallylamine to larvae of the clawed toad (Xenopus laevis) was determined using a method equivalent to OECD Guideline 202: Daphnia sp. Acute Immobilisation Test. 23 November 2004..

X. laevis larvae (3 -4 weeks old) were exposed to a series of 5 concentrations of allylamine for 48-hours. No measurements of test concentrations were performed and the 48 -h LC50 was estimated as a projection from the least square linear regression on log transformed nominal concentrations data and probit transformed per cent effect data.

The 48 -h LC50 of allylamine to X. laevis was 12.4 mg/L.