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GOTS认证咨询,厦门GOTS辅导公司,GOTS 投入物评估程序禁止用新的动物试验未知的 LD50 值

来源:本站 作者:深圳市肯达信企业管理顾问有限公司 陈小姐 575592846 发布时间:2020-09-11

1) Performing new animal tests to determine unknown LD50 values in the course of the GOTS assessment

procedure for inputs (refer to Section 2.3.3) is prohibited. Instead, alternative methods (e.g. Acute Toxicity Estimates (ATE); conclusions on analogy from similar products; validated structure-activity relationships; calculation from available data of substances contained; expert judgment; in vitro tests) shall be

used to determine unknown values.

GOTS 投入物评估程序(参照第 2.3.3 节)禁止用新的动物试验未知的 LD50 值。未知值应采用其它替代

方法[如:急毒性估计值(ATE)、类似产品的类推结论、已验证的构效关系、根据所含物质现有数据进行

计算、专家评定、体外试验]来判定。

2) Substances and preparations, such as alkalis and acids that fail to meet this requirement because of

their pH value only, are exempt from this requirement.

仅由于酸碱值导致的不符合此要求的物质和配制品(诸如:酸和碱)则除外。

3) Performing new fish and daphnia tests to determine unknown LC50 / EC50 values in the course of the

GOTS assessment procedure for inputs is prohibited. Instead, alternative methods such as Acute Toxicity Estimates (ATE); validated structure-activity relationships; conclusion on analogy from similar products;

calculation from available data of substances contained; fish egg test (embryo toxicity test (FET)); in vitro

test; IC50 algae; OECD 201 [72hr] shall be used to determine unknown values.

可接受的测试方法 [测试时间]:GOTS 投入物评估程序禁止采用新的鱼类和溞试验未知的 LC50/ EC50

值。未知的 LC50/ EC50 值应采用 OECD 203 [96 小时]和 OECD 202EC50 溞[48 小时] 之外的其它方法

{如:急毒性估计值(ATE)、已验证的构效关系、类似产品的类推结论、根据所含物质现有数据进行计

算、鱼卵实验[胚胎毒性试验(FET)]、体外试验}来判定;IC50 藻, OECD 201 [72 小时]

4) Accepted test methods: OECD 301A, OECD 301E, ISO 7827, OECD 302A, ISO 9887, OECD 302B, ISO

9888 or OECD 303A; alternatively, to meet the 70% level a preparation tested with one of the methods

OECD 303A or ISO 11733 a percentage degradation of at least 80% shall be shown - or if tested with

one of the methods OECD 301B, ISO 9439, OECD 301C, OECD 302C, OECD 301D, ISO 10707, OECD

301F, ISO 9408, ISO 10708 or ISO 14593, a percentage degradation of at least 60% shall be shown. To

meet the 95% level, if tested with any of the mentioned methods, a percentage degradation of 95% shall

be shown. Testing duration with each method is 28 days.

可接受的测试方法:OECD 301 A、OECD 301 E、ISO 7827、OECD 302 A、ISO 9887、OECD 302

B、ISO 9888 或 OECD 303 A;对于需达到 70%生物降解率的配制品,还可采用 OECD 303A 或 ISO

11733 方法来测试,但降解性测试结果应显示至少达到 80%,或者采用 OECD 301 B、ISO 9439、

OECD 301 C、OECD 302 C、OECD 301D、ISO 10707、OECD 301 F、ISO 9408、ISO 10708 或 ISO14593 方法测试,但测试结果应显示至少达到 60%。对于需达到 95%生物降解率的配制品,不论采用上

述哪种测试方法,其测试结果应显示达到 95%。各测试方法的测试时间都为 28 天。

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