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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
toxicity to other aquatic vertebrates
Remarks:
amphibian Xenopus laevis, larvae: (sub)lethal effects
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: U.S. EPA, Endocrine Disruptor Screening Program Test Guidelines, OPPTS 890.1100 Amphibian Metamorphosis (Frog) (October 2009)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Methomyl
EC Number:
240-815-0
EC Name:
Methomyl
Cas Number:
16752-77-5
Molecular formula:
C5H10N2O2S
IUPAC Name:
(E)-[1-(methylsulfanyl)ethylidene]amino N-methylcarbamate
Test material form:
solid: crystalline
Specific details on test material used for the study:
Methomyl technical
DPX-X1179-571
Purity: 99.4%

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
yes
Remarks:
water

Test organisms

Aquatic vertebrate type (other than fish):
frog
Test organisms (species):
Xenopus laevis

Study design

Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d

Test conditions

Hardness:
134-152 mg/L (as CaCO3)
Test temperature:
21.9 to 22.4°C
pH:
6.9 to 7.2
Dissolved oxygen:
3.6 - 6.8 mg/L
Nominal and measured concentrations:
Nominal: 0, 18.3, 56.0, 168.0 μg/L
Measured: 0, 17.0, 52.2, 186 μg/L
Details on test conditions:
The general experimental design entailed exposing tadpoles to 3 different concentrations of the test chemical (n = 4 replicates per concentration) and a dilution water control (n = 4 replicates). The primary endpoints evaluated were hind limb length, body length (snout to vent [SVL]), developmental stage, wet weight, thyroid histology, and daily mortality.
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
186 µg/L
Nominal / measured:
meas. (TWA)
Remarks on result:
other: no effects at the highest dose tested
Key result
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
> 186 µg/L
Nominal / measured:
meas. (TWA)
Details on results:
No statistically significant effects associated with any of the Amphibian Metamorphosis Assay endpoints were found during the present study. Mild histopathology of the thyroid glands was found in both the control and the test substance treatments and was determined by the certified pathologist to be unrelated to methomyl exposure. More specifically, the incidence rate of hypertrophy and hyperplasia was the highest in stage 61 (50% and 25%), lower in stage 62 and above (25% and 0%, 15% and 0% , and 10% and 0% at stages 62, 63, and 64, respectively), and the lowest in

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
21d NOEC = 186 μg/L (the highest concentration tested)
21d LOEC > 186 μg/L
Executive summary:

The effect of the test substance on the metamorphosis of the South African clawed frog, (Xenopus laevis), was assessed in a flow-through, 21-day test initiated with Nieuwkoop and Faber (3) (NF) stage 51 larvae in accordance with test guidelines (U.S. EPA, Endocrine Disruptor Screening Program Test Guidelines, OPPTS 890.1100 Amphibian Metamorphosis (Frog) (October 2009)). Nominal concentrations tested were 0, 18.3, 56.0, 168.0 μg/L. Measured concentrations were 0, 17.0, 52.2, 186 μg/L. The general experimental design entailed exposing tadpoles to 3 different concentrations of the test chemical (n = 4 replicates per concentration) and a dilution water control (n = 4 replicates). The primary endpoints evaluated were hind limb length, body length (snout to vent [SVL]), developmental stage, wet weight, thyroid histology, and daily mortality.

The test substance did not significantly alter 7-day hind-limb length (HLL) or 21-day HLL. No effect on median (NF) developmental stage was observed at 7 days or 21 days. Asynchronous development was not observed in any of the treatments. Alterations, including follicular hypertrophy, were observed in thyroid gland histopathology in the control and each test concentration, but were not considered to be test substance-related. No clinical signs of sub-lethal toxicity were observed in the definitive test. The NOEC (No Observable Effect Concentration) for the test substance in a 21-day amphibian metamorphosis assay study using South African clawed frog, Xenopus laevis, was 186 μg/L based on time-weighted, mean measured methomyl concentrations and AMA endpoints. The LOEC (lowest observed effect concentration, for the same endpoint(s) was >186 μg/L.