Reaction mass of methyl acetate and methanol

Toxicity to birds

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

long-term toxicity to birds

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Reference 2

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.

Description of key information

A large data set on mammalian toxicity is provided; additional testing on toxicity to birds is therefore not needed in compliance with section 9.6.1, column 2 of Annex X to Regulation (EC) 1907/2006 (REACH). Moreover, since the substance exhibits a low log Pow (see IUCLID section 4.7), secondary poisoning is unlikely to be a relevant exposure route and the endpoint was thus waived.

Additional information

According to section 9.6.1, column 2 of Annex X to Regulation (EC) 1907/2006 (REACH) any need for testing the long-term or reproductive toxicity to birds“should be carefully considered taking into account the large mammalian dataset that is usually available at this tonnage level”. Further , in the ECHA Guidance on Information Requirements and Safety Assessment, Chapter R.7c, Endpoint specific guidance (version 3.0, June 2017; currently being reviewed) it is stated that if the toxicity to mammals has been evaluated in detail for human health protection, new studies on the toxicity to birds should be ”a last resort in the data collection process”. In the same guidance document it is pointed out that “it is unlikely that a secondary poisoning risk will be identified for substances that:

• are readily biodegradable, and
• have a low potential for bioaccumulation in fish and earthworms (e.g. a fish BCF below 100, or in the absence of such data on neutral organic substances a log Kow below 3)

A large dataset on mammalian toxicity of the close structural analogues Methanol and Methyl acetate is provided in IUCLID chapter 7. The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. In this assessment, Methanol was considered worst case. The data indicate that the lethal dose of Methanol is high for most experimental animals (> 2000 mg/kg bw after single oral administration). This endpoint is hence regarded sufficiently covered by available data on mammalian toxicity of the read across source substances. Further testing onthe long-term or reproductive toxicity to birds is thus not needed in compliance with section 9.6.1, column 2 of Annex X to Regulation (EC) 1907/2006 (REACH).

In addition, the registration substance was assessed to be readily biodegradable (see IUCLID section 5.2.1) and there is no indication that it has potential to bioaccumulate or adsorb to the soil matrix or sediments (please see IUCLID section 5.4.1). Based on its intrinsic properties the substance is not regarded to be PBT or vPvB (please refer to IUCLID section 2.3). Its Log Kow was found to be 0.18 (please refer to IUCLID section 4.7), which is clearly below the trigger value of 3 mentioned in the ECHA Guidance Chapter R.7c (see above).

Thus, in case of indirect exposure to the aquatic or terrestric compartment, the substance is expected to rapidly degrade and not to persist or bioaccumulate. By following worst case assumptions the registration substance is not classified for environmental hazards in accordance with Regulation (EC) No 1272/2008 (CLP), as amended for the fifteenth time in Regulation (EU) No 2020/1182 (please see endpoint summary for IUCLID chapter 6). Furthermore, chemical safety assessments revealed that the registration substance as well as its structural analogues Methanol and Methyl acetate do not bear any risk for the environment (please refer to the chemical safety report attached to IUCLID section 13 and to the disseminated ECHA REACH dossiers for the read across source substances). Therefore, a risk for secondary poisoning is deemed very unlikely.

Therefore, in accordance with section 9.6.1, column 2 of Annex X to Regulation (EC) 1907/2006 (REACH) and taking into account animal welfare, this endpoint was waived. Nevertheless, supporting information on the toxicity of Methanol to birds is summarized below.

Supporting information

In a study by Clegg (1964) Methanol was administered to hen eggs of the Light Sussex and White Leghorn X White Leghorn/Rhode Island Red strain, both by injection into the yolk sac and by diffusion through the shell. 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% hatch. In none of the tests abnormal embryos were observed. The reliability of this study was classified Klimisch 4 because the documentation is insufficient for assessment (not assignable).

Conclusion

No reliable information on acute or chronic effects on birds is available. However, a large data set on mammalian toxicity is provided; additional testing on toxicity to birds is therefore not needed in compliance with section 9.6.1, column 2 of Annex X to Regulation (EC) 1907/2006 (REACH). Moreover, since the substance exhibits a low log Pow (see IUCLID section 4.7), secondary poisoning is unlikely to be a relevant exposure route and the endpoint was thus waived.