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

Endpoint summary

Description of key information

- skin irritation/corrosion: corrosive to skin

- eye irritation/corrosion: irreversible effects on the eye

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

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 irritation FeCl2, MnCl2, AlCl3 and HCl are regarded. MgCl2 as the only other substance of high concentration is disregarded as it is a salt of a strong acid and a strong base and therefore has no effect on pH and as its overall toxicity is very low, excluding cytotoxic effects.

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

- skin:

Except for HCl all ingredients alone are not to be classified for skin irritation/corrosion. HCl below 10 % in aqueous solution also needs not be classified. Nevertheless the pH of < 1 of the solution and the working experience of the registrant suggests that the substance is corrosive to skin. Following the precautionary principle a classification as corrosive to skin for the test substance is deemed appropriate.

- eye:

As all major ingredient (except water) have irreversible effects on the eye, the test substance is also deemed to have irreversible effects to the eye.

- skin:

FeCl2:

For FeCl2 Park 2004 is the key study. In the toxicity test performed according to GLP and OECD 404 it was reported that ferrous chloride caused weak (grade 1) oedema at the site of application when 0.5 g of moistened solid was applied to shaved rabbit skin. The edema observed disappeared 24 hours after the patch was removed. It is concluded that ferrous chloride is a very weak irritant. A classification is not necessary.

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.

In the DRAFT TOXICOLOGICAL PROFILE FOR MANGANESE, 2008, by the Agency for Toxic Substances and Disease Registry no indication is given that MnCl2 is a skin irritant.

AlCl3:

For AlCl3 Jones 1986 B is the key study. New Zealand White rabbits were treated with Chlorhydrol (AlCl3) according to GLP and OECD 404. No erythema and eschar formation nor oedema formation appeared on the treated skin of 3 rabbits. No other effects were found. A classification is not necessary.

HCl:

Potokar 1985 is the key study for skin irritation / corrosion of HCl. Rabbits were treated with 37 % HCl in aqueous solution according to OECD 404. The test item was corrosive to the rabbit skin. No other effects were found.

The ex-Unilever publication of York 1996 gives human patch test data on a 10% solution of HCl suggesting that 10% solutions of HCl should not be classified as “Irritant to the skin”. This publication also makes reference to additional in-vitro skin corrosivity data on HCl which suggests that solutions of 9.0 and 18.0% HCl would not be classified as corrosive to the skin, quoting Whittle and Basketter, 1993. This data support the selection of 10% as the specific concentration limit above which solutions of HCl and mixtures containing HCl would be classified as a “Irritant to the skin” and an “Eye to the skin” On the other hand, a the results of a briefly reported human volunteer study on a single concentration of HCl appears to be consistent with the selection of 10 % as the lower concentration limit for skin irritancy in humans.

- eye:

FeCl2:

Ferrous chloride was shown to be corrosive to the rabbit eye in a GLP compliant guideline study in which 100 mg of ferrous chloride were applied to the conjunctival sac (Jeong & Sik 2004). This result may be a consequence of oxidation of ferrous to ferric, which will occur rapidly in the presence of water.

MnCl2:

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

In the DRAFT TOXICOLOGICAL PROFILE FOR MANGANESE, 2008, by the Agency for Toxic Substances and Disease Registry no indication is given that MnCl2 is an eye irritant.

AlCl3:

For AlCl3 Jones 1986 C is the key study. One eye of three rabbits each was exposed to the test substance (Chlorhydrol = Al Cl3) according to OECD Guideline 405. Observation occurred at 1, 24, 48, 72 hours and at day 7. A dulling of the normal lustre of the corneal surface was noted in all treated eyes but only at the one hour observation. The cornea of all treated eyes appeared normal at subsequent observations. Iridial inflammation was noted in all treated eyes but only at the one hour observation. No iridial irritation was noted at subsequent observations. Conjunctivitis was noted in all treated eyes one hour after treatment and was still apparent in two of the three treated eyes at the 72-hour observation. The remaining treated eye appeared normal at this time and all treated eyes were normal on day 7.

The test material, Chlorhydrol Ultrafine, was found to be non-irritant according to present classification guidelines.

HCl:

In a reliable eye irritation study (Jacobs 1988, Klimisch score 2) conducted according to OECD 405 0.1 mL HCl aqueous solution at 10% was placed on the lower conjunctival sac of 6 New Zealand Albino rabbits.The eyes were scored according to Draize at 4, 24, 48, 72 and 96 hours. One drop of 2% sodium fluorescein was applied before the visual scoring of percentage corneal damage. The test item caused serious eye damage and is to be classified as corrosive to the eyes.

In Reer 1976 rabbits were treated with varying amounts of 5 % w/w HCl in aqueous solution equivalent to OECD 405. While 0.1 and 0.03 mL of the test item produced irreversible effects, 0.01 and 0.003 mL produced only relatively mild effects that were fully reversible within 24 h.

- inhalation:

FeCl2:

No animal data available.

human data:

Kleinman 1981 (see chapter 7.10.2) carried out a human volunteer study to investigate the effects on pulmonary function and respiratory symptoms following 2 hours’ inhalation of ferric sulfate aerosols. The number of subjects, (age range 18 to 55) was 38, of which 20 exhibited normal pulmonary function with no history of lung diseases and 18 subjects were diagnosed as asthmatics. The nominal concentration was 0.075 mg/m³ ferric sulfate (equivalent to 0.02 mg Fe/m³). Based on this study, it has been concluded that the NOAEC in humans for acute respiratory effects would probably be higher than 0.02 mg Fe/m³ of respirable aerosols for a 2-hour exposure period.

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 states that acute or intermediate exposure to excess manganese can cause an inflammatory response in the lung. Nevertheless no clear time-response or dose response data is given.

AlCl3:

No data is available.

HCl:

Information on respiratory irritation upon HCl exposure was analysed by Burleigh-Flayer 1985 in guinea pigs (see chapter 7.2.3 of this dossier). Exposure of guinea pigs to hydrochloric acid aerosol by inhalation for 30 min resulted in both sensory and pulmonary irritation at all exposure concentrations, including the lowest concentration tested (320 ppm). The maximal respiratory frequency achieved during the CO2 challenge was lower in HCl-exposed animals than in controls in a concentration-dependant manner, but exposure to HCl had no apparent effect on the maximal tidal volume. Corneal opacities were noted in animals exposed to the two higher concentrations, and in a single animal exposed to 680 ppm. Tissue damage in both the airway and alveolar regions was noted both after 2 or 15 days following exposure, indicating that complete recovery was not attained in animals exposed to 1040 ppm.

These results were confirmed by an additional study by Buckley 1984 (see section 7.5.3 of this dossier) where a RD50 of HCl(gas) was described for rats.

Justification for classification or non-classification

- skin:

Based on the assessment of the probable effects on skin, stated above, the test substance is classified as corrosive to skin (R34 Causes burns) according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and Category 1B (Danger; H314: Causes severe skin burns and eye damage) according to CLP (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) as implementation of UN-GHS in the EU.

- eye:

Based on the assessment of the probable effects on the eye, stated above, the test substance is classified as corrosive to the eye (R41 Risk of serious damage to eyes) according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and Category 1B (Danger; H318: Causes serious eye damage) according to CLP (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) as implementation of UN-GHS in the EU.