Reaction mass of aluminium chloride, iron dichloride, magnesium chloride and manganese dichloride

Endpoint summary

Description of key information

- skin sensitisation: positive based on the concentration of nickel chloride

- respiratory sensitisation: no indication

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

The test substance is a watery solution of metal chlorides and free hydrogenchloride.

The irritation/corrosion potential of this mixture has therefore to be regarded as a summary of the effects of the different ingredients. Due to the relative concentrations for sensitisation FeCl2, MnCl2, AlCl3 and HCl are regarded. MgCl2 the only other substance of high concentration is disregarded due to the low overall toxicity of this substance and as both chloride and magnesium ions are essential for cellular life and present in every cell in high abundance.

As nickel is of special interest regarding sensitisation NiCl2 is included in the assessment.

Summary:

The summary is based on the data presented below. Calculations are based on the following composition:

	% (w/w) in solution	MW (Metal) g/mol	M = mol/L	mol % Metal		MW (compound) g/mol	% (w/w) in solution	% (w/w) dry substanz
Fe	9.5224	55.85	1.7050	62.7	FeCl2	126.75	21.60	63.18
Al	0.6813	26.98	0.2525	9.3	AlCl3	133.34	3.38	9.881
Mg	0.6497	24.30	0.2674	9.8	MgCl2	95.22	2.61	7.634
Mn	1.4832	54.94	0.2700	9.9	MnCl2	125.84	3.40	9.945
					HCl	36.46	1.3	3.80
Ni	0.0080	58.69	0.0014	0.1	NiCl2	129.60	0.0176	0.0515

- skin:

None of the ingredients of the test substance are classified as skin sensitisers except for nickel chloride. As the nickel chloride content is above the threshold of 0.01 % (COMMISSION REGULATION (EC) No 790/2009 Index No 028-011-00-6 (nickel chloride)), the test substance needs to be classified as skin sensitizer.

- skin:

FeCl2:

Ferrous sulfate heptahydrate has been tested in a guideline, GLP, Local Lymph Node Assay (Stitzinger, 2010: reliability 1). In this test ferrous sulfate gave a clear negative result, and is therefore not considered a skin sensitiser. The result is in-line with findings in a non-reliable study on ferrous sulphate (Ikarashi 1992). As chloride ions and sulfate ions are essential ions and present in all living cells in high abundance the result for ferrous sulfate can be read across to ferrous chloride.

MnCl2:

Due to a delay in the correspondance between the registrant of this test substance and the Manganese Consortium, no first hand animal data is available.

Secondary data from the DRAFT TOXICOLOGICAL PROFILE FOR MANGANESE, 2008, by the Agency for Toxic Substances and Disease Registry also does not mention a sensitisation potential of manganes compounds.

AlCl3:

For AlCl3 Jones 1986 D is the key study. The sensitizing potential of Chlorhydrol Ultrafine was analyzed in guinea pigs (Guinea Pig Maximisation Test, OECD 406). 20 animals were exposed once intradermally (0.1%) and 2 times epicutaneously (50%) to the test article. 10 control animals were only exposed once epicutaneously (50%) during challenge. Positive skin reactions were evaluated according to a grading scale, and were used to calculate the sensitization rate. Body weights were measure before and after study.

No positive skin were observed, the sensitization rate was established to be 0%. Body weight gain was comparable between the test and control group. As the sensitization rate of 0% does not exceed the threshold value of 30%, the substance does not need to be classified as a sensitizer based on the present classification criteria.

HCl:

Gad 1986 is the key study for HCl. The results of aqueous hydrogen chloride were compared betwen the Mouse Ear Swelling Test (MEST) method and the Guinea Pig Maximization Test (GPMT) method the latter of which was conducted in accordance with OECD 406. Female mice were inducted by receiving intradermal injections of FCA (day 0 only) plus topical applications of hydrochloric acid (1% in 70% ethanol) in the stomach area previously clipped free of fur and tape-stripped up to a glossy appearance of the skin (days 0, 1, 2 and 3). Challenge was done applying hydrochloric acid (5% in 70% ethanol) to the left ear, the right one receiving the vehicle alone. Swelling of the ears were measured using a micrometer 24 and 48 hours after application and comparing the results obtained in concurrent control animals. GPMT was also carried out in 15 guinea pigs. The result was negative in both cases.

human data:

The skin sensitization potential of Hydrogen chloride in water was assessed in a human repeat patch study (Ryan 1987, see chapter 7.10.4). A total of 128 subjects participated in the study. Subjects were exposed to 9 induction patches containing 0.5 ml Hydrogen chloride in water under occlusion on a Monday, Wednesday and Friday schedule for a period of 3 weeks. Patches were removed 24 hours after each application and patch sites were graded at 48 hours after patch application prior to the next patch application. After 2 week rest period, subjects were challenged with 0.5 ml Hydrogen chloride in water (B1150.01) (24 hour patch exposure). Challenge patch sites were graded at 48 and 96 hours after patch application.

In this study, 119/128 subjects completed the study. A total of 9 subjects were dropped. Two subjects were dropped because they could not contact, five were out of town, while one other subject has started steroid medication and one forgot to attend the test.

No positive response indicative of skin sensitization was observed.

Hydrogen chloride in water did not produce skin sensitization in human.

NiCl2:

According to COMMISSION REGULATION (EC) No 790/2009 Index No 028-011-00-6 (nickel chloride) mixtures that include nickel chloride have to be classified as skin sensitizers down to 0.01 % (w/w).

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

FeCl2:

No data available.

MnCl2:

Due to a delay in the correspondance between the registrant of this test substance and the Manganese Consortium, no first hand animal data is available.

Secondary data from the DRAFT TOXICOLOGICAL PROFILE FOR MANGANESE, 2008, by the Agency for Toxic Substances and Disease Registry also does not mention a sensitisation potential of manganes compounds.

AlCl3:

No data is available.

HCl:

No data is available.

NiCl2:

No data is available.

Justification for classification or non-classification

- skin:

Based on the assessment of the sensitizing effects on skin, stated above, the test substance is classified as skin sensitiser (R43 May cause sensitisation by skin contact) according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and Category 1B (Warning; H317: May cause an allergic skin reaction) according to CLP (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) as implementation of UN-GHS in the EU.

- respiration:

There are no indications that the test substance is a respiratory sensitisers.