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EC number: 204-327-1
CAS number: 119-47-1
The substance is not legally classified as dangerous for the environment
and so neither included in Annex I of Directive 67/548/EEC nor in
Regulation 1272/2008 (CLP), including its 2nd and 3th ATP.
A scientific assessment is performed in order to decide whether the
classification criteria covering effects on the aquatic environment
shall be assigned for 6,6’-di-tert-butyl-2,2’-methylenedi-p-cresol.
As outlined in Annex VI of Directive 67/548/EEC, Chapter 5 and Annex I
of the Regulation 1272/2008, Chapter 4, the available data on aquatic
toxicity for the substance are evaluated for hazardous effects with
regard to the substance properties, in particular the water solubility.
As a conclusion, a hazardous potential of the substance can be ruled out
and hence no classification according to and the Dangerous Substance
Directive 67/548/EEC (DSD) or Classification. Labelling and Packaging
Regulation EC 1272/2008 (CLP) is required. The following aspects have
been taken into account:
1. Consideration for difficult substance:
With an experimentally determined water solubility of 0.007 mg/l
6,6’-di-tert-butyl-2,2’-methylenedi-p-cresol is only poorly soluble in
water. Therefore it can be considered as a difficult substance for
environmental hazard assessment regarding REACH guidance R.7b.
2. Media preparation method
Due to the low water solubility of the substance (0.007 mg/l), a
dispersant-solubilizer system (DMF/Castor oil HCO-40, 3/1 (w/w)) was
used in all toxicity tests and stability of the test substance was
monitored using GC-MS. A homogenous solution could be attained only at
(and less than) the nominal concentration of 5.0 mg/l with the maximum
allowable dispersant concentration of 100 mg/l. No precipitations or
emulsions were observed at this nominal concentration.
The analytical results show stability of the test substance during each
experiment and a recovery rate greater than 80 % of the nominal test
concentrations. Thus it is shown that the dispersant-solubilizer system
significantly increases the solubility of
6,6’-di-tert-butyl-2,2’-methylenedi-p-cresol in water. All measured test
concentrations used in the aquatic toxicity tests were far exceeding the
water solubility of the substance, representing unrealistic
environmental conditions. Consequently, the effects observed in the
aquatic toxicity tests are also at levels higher than the water
3. Interpretation of ecotoxicity test results
In the following table, the most relevant data used for classification
purposes are presented:
Table: Data on aquatic toxicity, degradation and bioaccumulation of
ErC50 > 5.0
NOEC = 1.3
EA Japan (1999)
EC50 > 4.8
NOEC = 0.34
LOEC = 0.89
Based on the characteristic as difficult substance and the use of
dispersant-solubilizer in media preparation, the test results for
6,6’-di-tert-butyl-2,2’-methylenedi-p-cresol shall be assessed with care.
As no effects are observed up to the limit of the water solubility, the
substance is considered to be not toxic (acute and chronic) for aquatic
Conclusion on the environmental hazard assessment and on classification
Based on substance properties (not readily biodegradable, BCF > 100 /
500) the substance might be classified as R53 “May cause long-term
adverse effects in the aquatic environment” according to Directive
67/548/EEC and Chronic Cat 4 (H412“May cause long lasting harmful
effects to aquatic life) according to Regulation 1272/2008.
Table: Data degradation and bioaccumulation of
The “safety net criteria” apply to substances unless there exists
additional scientific evidence concerning degradation and/or toxicity
sufficient to provide an adequate assurance that neither the substance
nor its degradation products will constitute a potential long-term
and/or delayed danger to the aquatic environment.
Additional scientific evidence is provided by a Daphnia magna
reproduction study performed under semi static conditions. The study was
conducted in accordance with the OECD Test guideline 211. No toxic
effects on reproduction and mortality against Daphnia were observed up
to the limit of the water solubility. This result clearly indicates the
absence of any chronic toxicity effects at the solubility limit, as the
no-observed effect concentration is greater than the solubility limit
determined in this study.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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