Candida and SIDS

SIDS INITIAL ASSESSMENT PROFILE

CAS NO	121-14-2
Chemical Name	2,4-Dinitrotoluene
Structural formula
RECOMMENDATION OF THE SPONSOR COUNTRY [ X ] presently of low priority for further work [ ] requiring further information to assess identified concerns [ ] candidate for in-depth risk assessment with a view to possible risk reduction activities
SHORT SUMMARY WHICH SUPPORT THE REASONS FOR THE RECOMMENDATIONS The production volume of 2,4-Dinitrotoluene (2,4-DNT) is ca. 140,000 t/a in Germany and ca. 264,000 in the USA. The worldwide production is estimated at ca. 850000 t/y. Nearly the entire production volume is used as intermediate in chemical synthesis. The only direct use known is as additive in explosives. 2,4-DNT can be regarded as "inherently biodegradable" with low to moderate bioaccumulation.. The most sensitive environmental species to 2,4-DNT is the crustacean Daphnia magna (21d-NOEC = 0.04 mg/l). The derived aquatic PNEC is 4 µg/l. The substance is harmful with oral administration (acute LD50 = 400 - 1954 mg/kg bw). It is mutagenic in the Ames test and in in vivo tests on mammals. The NOEL for repeated dose toxicity is 0.57 - 0.71 mg/kg bw/day (2-year study). No teratogenic effects were recorded and impairment of fertility were observed at doses which also cause other effects. The highest aquatic local PEC due to production and processing was estimated to be 1.66 µg/l in Germany and 56 µg/l for a production site in the USA. For the PEC calculation (for production and processing plants plants without exposure information), the default values defined in the EU Technical Guidance Documents on Risk Assessment for New and Existing Substances are used (data about the discharges via waste water are not available for production and processing plants outside of Germany). For a production plant with an unknown site location a PEClocal of 245 µg/l and for a processing plant a PEClocal of 570 µg/l is calculated. The EHD for inhalational exposure is estimated at <0.071 mg/kg bw. Consumer exposure is not to be expected. In conclusion, there is currently no risk to be expected to the environment or to humans for the 3 known production and processing sites in Germany. For a known production site in the USA, 2,4-DNT represents presently a risk for the aquatic compartment. A comparison of the predicted environmental concentrations for a production and a processing site (plants without exposure information, hypothetical unknown site location with a hypothetical capacity 1000 t/y) and the predicted no-effect concentration for aquatic ecosystems indicates that a risk of damage to aquatic ecosystems is to be expected.
IF FURTHER WORK IS RECOMMENDED, SUMMARISE ITS NATURE Site specific exposure data have to be improved for all production and processing sites.

FULL SIDS SUMMARY

CAS-NO.: 121-14-2			PROTOCOL	RESULTS
PHYSICAL CHEMICAL
2.1	Melting Point		NA	69.9 °C
2.2	Boiling Point		NA	319.5 °C (at kPa)
2.3	Density		NA	1286 kg/m3
2.4	Vapour Pressure		NA	7.9.10-6 kPa at RT °C
2.5	Partition Coefficient (Log Pow)		NA (exp.)	1.98
2.6 A	Water solubility		NA	166 mg/l at °C
B	pH		/	at °C
	pKa		/
2.12	Oxidation : Reduction potential		/	mV
ENVIRONMENTAL FATE / BIODEGRADATION
3.1.1	Photodegradation		calc. (Atkinson)	In air T1/2 = 71 days
3.1.2	Stability in water (Photodegr.)			T1/2 = 6.5 - 20 days
3.2	Monitoring data			In air = / mg/m3
				In surface water = 0.1 - 2.0 mg/l
				In soil/sediment = 0.01 - 0.07 mg/g
				In biota = / mg/g
3.3	Transport and Distribution		calculated
			(fugacity	In water ca. 98 %
			level 1 type)
3.5	Biodegradation		NA	not readily biodegradable inherently with adapted inoculum

FULL SIDS SUMMARY (cont)

CAS-NO.: 121-14-2		SPECIES	PROTOCOL	RESULTS
ECOTOXICOLOGY (lowest effect concentrations only)
4.1	acute/prolonged toxicity to fish	Lepomis macrochirus	EPA-660/3-75-009	LC50 (96 hr) = 12.8 mg/l
4.2	acute/prolonged toxicity to aquatic invertebrates (daphnia)	Daphnia magna	EPA-660/3-75-009	EC50 (24 hr) = 22 mg/l
4.3	toxicity to aquatic plants e. g. algae	Microcystis aeruginosa	EPA (1971)	TLV (96 hr) = 0.05 mg/l
4.4	toxicity to microorganisms	Uronema parduczi	NA	TLV (20 hr) = 0.55 mg/l
4.5.1	chronic toxicity to fish	Lepomis macrochirus	NA	TLV (8 w) = 0.05 mg/l
4.5.2	chronic toxicity to aquatic invertebrates (daphnia )	Daphnia magna	UBA (1984)	NOEC (21 d) = 0.04 mg/l
4.6.1	toxicity to soil dwelling organisms	Folsomia candida	BBA (1991)	EC10 (33 d) = 2.8 mg/kg
4.6.2	toxicity to terrestrial plants	Lactuca sativa	OECD 208	EC50 (14 d) = 4.9 mg/kg
TOXICOLOGY
5.1.1	acute oral toxicity	rat	NA	LD50 = 400 mg/kg
5.1.2	acute inhalation toxicity	/	/	LC50 = mg/m3
5.1.3	acute dermal toxicity	rat	NA	LD50 = >2500 mg/kg
5.4	repeated dose toxicity	rat (CD)	(2-year study)	NOEL= 0.57 - 0.71 mg/kg
5.5	genetic toxicity in vitro
	bacterial test (gene mutation)	S. typhimurium	Ames test	+ (with metabolic activation) + (without metabolic activation)
	non-bacterial in vitro test (chromosomal abberations)	CHO K1		- (with metabolic activation) - (without metabolic activation)
5.6	genetic toxicity in vivo	rat (Fischer)		positive
5.8	toxicity to reproduction	/	/	NOEL = mg/kg (general toxicity) NOEL = mg/kg (rep. tox. parental) NOEL = mg/kg (rep. tox. F1)
5.9	developmental toxicity / teratogenicity	/	/	NOEL = mg/kg (general toxicity) NOEL = mg/kg (pregnancy/litter) NOEL = mg/kg (foetal data)
5.11	experience with human exposure

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       Toxicological Abbreviations