Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.1 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.01 mg/L
Assessment factor:
10 000

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
100 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.465 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.046 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.156 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Category Justification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances.

Applying the category approach read-across concept to SDIBP, data will be used from a representative member of the hydrotropes category to avoid unnecessary (animal) testing. The endpoints for which the read-across approach to SDIBP is applied, are: toxicokinetics, short-term toxicity to fish, toxicity to microorganism, acute toxicity (inhalation and dermal), skin irritation/corrosivity, skin sensitisation, genetic toxicity (in vitro, in vivo), repeated-dose toxicity (oral and dermal), screening for carcinogenicity, and screening for reproductive / developmental toxicity. 

Environmental assessment related key information for SDIBP:

SDIPB and the hydrotrope members are considered to be hydrolytically stable, as they contain no chemical groups liable to hydrolysis. Furthermore, a low potential for bioaccumulation in aquatic and terrestrial organisms is expected, based on the low measured octanol/water partition coefficients (log Kow). Although the hydrotrope category is considered to be readily biodegradable and the available data on biodegradation of SDIPB only indicates inherently biodegradable, the supporting biodegradation data of SDIPB indicates that there is similar biodegradation potential.

Both SDIPB and the hydrotrope members are highly soluble in water and exhibit low acute toxicity to aquatic species. Hence it is deemed correct to fill the existing data gaps on environmental fate and ecotoxicity of SDIPB with the data of the hydrotrope category.

 

 

 

Conclusion on classification

In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, Information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI (1.5) of REACH regulation are met. Substances whose physico-chemical and/or toxicological and/or ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity, may be considered as a group, or ‘category’ of substances. Application of the group concept requires that physico-chemical properties, human health effects and environmental effects or environmental fate may be predicted from data for reference substance within the group by interpolation to other substances in the group.

Since the group concept is applied the members of the hydrotropes category, data will be generated from a representative category member to avoid unnecessary animal testing.

Environmental Classification related key information for SDIBP:

It is considered to be hydrolytically stable, as SDIBP contains no chemical groups liable to hydrolysis. Furthermore, a low potential for bioaccumulation in aquatic and terrestrial organisms is expected, based on the low measured octanol/water partition coefficients (log Kow).

Biodegradation in water: inherently biodegradable (OECD 301B)

Bioaccumulation: no potential to bioaccumulate; log Kow -3.11

Water solubility: > 330 g/L at 20 ºC (OECD 105)

Acute toxicity data for aquatic organisms:

For fish: 96-h LC50 to Oncorhynchus mykiss= 1000 mg/kg (similar to EPA OTS 97.1400; read-across from sodium xylene sulphonate)

For invertebrates: 48-h EC50 to Daphnia magna, immobilization = 100 mg/L (OECD 202).

For algae: 72-h ErC50 to the Pseudokirchneriella subcapitata, growth rate = 100 mg/L (OECD 201).

For microorganism: 3h EC10 to the activated sludge, respiration inhibition= 1000 mg/L(OECD 209; read-across from sodium cumene sulphonate).

 

Chronic toxicity:

For algae:72-h NOEC to the Pseudokirchneriella subcapitata, growth rate = 100 mg/L (OECD 201).

Based on available acute toxicity data for SDIPB, the lowest valid effect concentration for freshwater aquatic organisms is 100 mg/L (EC50 value for the algae and daphnia). SDIBP is highly water soluble, inherently biodegradable and has a logKow is < 4 (logKow: -3.11).Based on the available data the substance should not be classified for Acute aquatic toxicity. As the NOEC for algae is > 1 mg/L (72h-NOECr: 100mg/L) the substance should not be classified for chronic aquatic toxicity either, following section 4.1.2.6 of the CLP Regulation.Therefore a classification for environmental effects is not required.Based on the same criteria the substance should not be classified under the Dangerous Substance Directive 67/548/EC (see Annex VI section 5.2.1.2).