Spinflam MF 83 PP-25

Endpoint summary

Description of key information

Oral LD50 > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

ACUTE TOXICITY - ORAL ROUTE

The LD50 of the test item administered to rats by oral route was established as greater than 2000 mg/Kg. No death or clinical changes occurred in the animals during the oral acute toxicity test and at the autopsy carried out at the end of the observation period, no appreciable macroscopic findings were evident in any treated rat.

ACUTE TOXICITY - INHALATION ROUTE

According to the REACH Regulation annex VIII column 2 (specific rules for adaptation from column 1) in addition to the oral route (8.5.1), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. No systemic toxicity was seen via the oral route and/or was observed in the skin/eye irritation and/or skin sensitization studies; the eye irritation effects observed in the test on DG HF 2000 regards only the conjunctival redness and are fully reversible within seven days.

ACUTE TOXICITY - DERMAL ROUTE

Currently, according to the REACH Regulation annex VIII column 2 (specific rules for adaptation from column 1) testing by the dermal route is appropriate if inhalation of the substance is unlikely; and skin contact in production and/or use is likely; and the physical/chemical and toxicological properties suggest potential for a significant rate of absorption through the skin.

The dermal contact of Spinflam DG HF 2000 is unlikely. Furthermore, due to the physical/chemical properties of the substance the dermal absorption is expected as negligible.

The 15th Meeting of Competent Authorities for REACH and CLP [CARACAL, 2014] concluded that an adaptation of point 8.5.3 of Annex VIII to REACH is justified in order to not require information on acute dermal toxicity for substances that have shown no toxicity in acute oral toxicity test up to the limit dose of 2000 mg/kg bw. Furthermore, the Commission services agree that information on acute toxicity via the dermal route should indeed be provided in cases where indications for systemic toxicity in other studies with dermal application (skin irritation or sensitisation studies) has been observed (with the exception of cases where the substance has been shown to be corrosive to skin, which under point 8.5 of Annex VIII to REACH it allows waiving of any acute toxicity testing).

DG HF 2000 does not meet the criteria for classification as acute toxic by the oral route; no death or clinical changes occurred in the animals administered by oral route at the dose of 2000 mg/kg bw and no appreciable macroscopic findings were evident in treated animals examined. Furthermore, no systemic toxicity was recorded in both the other available tests with dermal application of skin irritation and skin sensitization.

FURTHER INFORMATION: review of existing data

PIPERAZINE

Piperazine has a low acute toxicity (LD50 1-5 g/kg bw) by the oral, dermal, and subcutaneous route of administration to rodents. The lethal dose in humans was not established. However, there are findings of EEG changes in 37 % of 89 children administered 90-130 mg/kg piperazine base (two doses during one day), corroborated by the proposed GABA receptor agonism exerted by piperazine. Since more severe neurotoxicity symptoms can appear after exposure to higher doses (divided under several days), a LOAEL of 110 mg/kg for neurotoxicity in humans after acute exposure has been proposed [European Chemicals Bureau, 2005].

 

MELAMINE

The toxicity to mammals is very low. Data about the acute toxicity by oral and dermal routes are available and in both cases no reasons of concern were recorded [OECD SIDS, 1998 and EFSA, 2010].

 

PHOSPHATES

Available data on the Sodium Tripolyphosphate indicated that it can be considered of low acute toxicity potential by both, the oral and dermal routes. No reasons of concern were reported by inhalation route and, in addition, review of studies performed on a range of inorganic phosphates tends to support a low potential toxicity via this route for these compounds [HERA, 2003].

MELAMINE POLYPHOSPHATE

Melamine polyphosphate is expected to be of low hazard for acute toxicity based on experimental evidence. When administered orally to rats melamine polyphosphate does not produce mortality up to the dose of 2000 mg/kg bw [EPA, 2014].

PIPERAZINE PYROPHOSPHATE

As stated in the EPA document [EPA, 2014] the hazard was estimated to be low for oral and dermal routes of exposure to the substituted amine phosphate and piperazine components of the mixture.

Reference

CARACAL, 2014. 15th Meeting of Competent Authorities for REACH and CLP (CARACAL), 8 – 9 July 2014. Charlemagne building, Brussels, Belgium. Brussels, 26 July 2014. Doc. CA/61/2014. Stakeholder proposal to modify REACH standard information requirements for acute toxicity (REACH Annex VIII, point 8.5).

Environmental Protection Agency (EPA) United States. An Alternatives Assessment for the Flame Retardant Decabromodiphenyl Ether (DecaBDE). Final report. January 2014.

European Chemicals Bureau; Joint Research Centre (2005). European Union Risk Assessment Report. Piperazine CAS 110-85-0 EC: 203-808-3. 3rd Priority List Volume: 56. Office for Official Publications of the European Communities, 2005.

European Food Safety Authority (EFSA), 2010. Scientific Opinion on Melamine in Food and Feed. EFSA Panel on Contaminants in the Food Chain (CONTAM) and EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF). European Food Safety Authority (EFSA), Parma, Italy. EFSA Journal 2010; 8(4):1573.

Human & Environmental Risk Assessment (HERA) on ingredients of European household cleaning products. Sodium Tripolyphosphate (STPP) CAS: 7758-29-4. Draft, June 2003.

OECD SIDS, 1998. Melamine CAS N°: 108-78-1. UNEP Publications.

Justification for selection of acute toxicity – oral endpoint
Test conducted according to internationally accepted testing procedures and according to the GLP.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

The oral LD50 value was established to be greater than 2000 mg/kg body weight, therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity category 4: 300 < ATE ≤ 2000 mg/kg bw).

Dermal and inhalation exposure is unlikely, thus no acute toxicity value is available and no further investigation is required.

In conclusion, the test substance is not classified for oral acute toxicity, according to the CLP Regulation (EC 1272/2008).