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Toxicity to birds

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Endpoint:
long-term toxicity to birds: reproduction test
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test compound has been administered to hen eggs, both by injection into the yolk sac and by diffusion through the shell.
GLP compliance:
no
Dose method:
other: injection or diffusion
Analytical monitoring:
not specified
Vehicle:
not specified
Test organisms (species):
other: hen eggs from Light Sussex hens and White Leghorn X White Leghorn/Rhode Island Red Strain
Details on test organisms:
TEST ORGANISM
- Source: Messrs. Needls, Cuffley, Herts. and Y. Watanabé Ltd, Hatchford, Surrey)
Remarks:
max. 10 sec. in diffusion tests
No. of animals per sex per dose and/or stage:
up to 96 hen eggs
Control animals:
yes

The injection of 0.1 mL Methanol into 5-day incubated eggs (n=5) resulted in 20% hatch.

A partial immersion of 5-day incubated eggs (n=5, 37°C) for 5 seconds resulted in 60% hatch, immersion for 10 seconds with 10 eggs at 20°C resulted in 50% hatch.

A partial immersion of unincubated eggs (n=9, room temp.) for 10 seconds resulted in 66%.

In none of the tests abnormal embryos were observed.

Endpoint:
long-term toxicity to birds
Data waiving:
other justification
Justification for data waiving:
other:

Description of key information

Key value for chemical safety assessment

Additional information

In water, potassium methanolate rapidly hydrolyses to methanol and potassium hydroxide (OECD, 2002). Due to the rapid hydrolysis of potassium methanolate, the assessment of the toxicity to birds is based on the products of hydrolysis i.e. methanol and potassium hydroxide.

No studies on the toxicity of potassium methanolate to birds are available. The relevant degradation products of potassium methanolate are of low mammalian toxicity (see IUCLID Section 7) and do not have the potential for bioaccumulation. Thus, there is no risk for secondary poisoning and testing of the toxicity to birds not required and waived.

According to ECHA Guidance document R.7c published by ECHA (2017) testing for avian toxicity is not required if a risk for secondary poisoning is negligible (e.g. if the substance is readily biodegradable, has a low potential for bioaccumulation and moreover there is no evidence of toxicity in mammalian repeat dose or reproduction tests). Regarding the results from mammalian studies for methanol, only low toxicity is indicated. In addition, the available aquatic toxicity data on methanol only indicate low toxicity to birds. Furthermore, methanol is readily biodegradable and the potential for bioaccumulation is assumed to be low based on the low log Pow. Thus, methanol has a negligible risk for secondary poisoning and there is no need to investigate further the effects on birds.

For the sake of completeness, the available study on the relevant degradation product methanol indicating a low level of toxicity to birds is presented. In this study, the effects of methanol on 5-day incubated Gallus gallus domesticus eggs were investigated. The injection of 0.1 mL methanol into 5-day incubated eggs (n=5) resulted in 20% hatch. A partial immersion of 5-day incubated eggs (n=5, 37 °C) for 5 seconds resulted in 60% hatch, immersion for 10 seconds with 10 eggs at 20 °C resulted in 50% hatch and a partial immersion of un-incubated eggs (n=9, room temp.) for 10 seconds resulted in 66%.

In conclusion, there is no need for additional testing of methanol on the toxicity to birds.