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EC number: 237-714-9
CAS number: 13939-25-8
Skin irritation/corrosion: not corrosive and not irritating in vitro (OECD 431 and 439, GLP)Eye irritation: irritating Category 2 (OECD 405, GLP)Respiratory irritation: no study available
Table 1. Individual eye irritation scores
Pt = Small area of petechial haemorrhage on the nictitating membrane
Skin corrosion (in vitro)
The corrosivity potential of aluminium dihydrogen triphosphate was
tested using the EPISKIN™ in vitro Reconstituted Human Epidermis (RHE)
Model following OECD Guideline 431 and complying with GLP (Warren,
2012). Duplicate tissues were treated with 20 mg of the test material
for 3, 60 and 240 min. Duplicate tissues treated for 240 min with 50 µL
0.9% w/v sodium chloride or glacial acetic acid served as negative and
positive controls, respectively. At the end of the exposure period,
tissues were rinsed prior to MTT loading. Formazan crystals were
extracted from the MTT loaded tissues by acidic isopropanol extraction.
The optical density of the extracts was measured at 540 nm. The relative
mean viability (MTT reduction to formazan in treated vs. negative
control tissues) was calculated as percent mean optical density of the
isopropanol extracts from treated tissues relative to the negative
The relative mean viability of tissues treated with the test
material was 105.0, 93.3 and 106.1% after 3, 60 and 240 min,
respectively. The relative mean viability of the positive control
treated tissues was 16.1% after 240 min.
Therefore, based on the study results, the test material does not
meet the criteria for classification for Skin corrosion Category 1
according to Regulation (EC) No 1272/2008 (CLP) or the Globally
Harmonized System (GHS), and is thus considered to be not skin corrosive
Skin irritation (in vitro)
In another GLP-compliant in vitro study, the skin irritation
potential of aluminium dihydrogen triphosphate was evaluated using the
EPISKIN™ RHE Model according to OECD Guideline 439 and EU Method B.46
(Warren, 2012). Triplicate tissues were treated with 10 mg of the test
substance for 15 min, followed by rinsing and a 42 h post-exposure
incubation period. Triplicate tissues concurrently treated with 10 µL of
Dulbecco’s Phosphate Buffered Saline (DPBS) with Ca++ and Mg++ or Sodium
Dodecyl Sulphate (SDS) 5% w/v served as negative and positive controls,
respectively. Following the post-exposure period, MTT tissue loading and
determination of relative mean viability was performed as described
above under ‘Skin corrosion (in vitro)’.
The relative mean viability of the test substance-treated tissues
was 128.1% of the negative control value, while the relative mean tissue
viability of the positive control was 8.6%.
Therefore, based on the study results, the test item does not meet
the criteria for classification according to Regulation (EC) No
1272/2008 (CLP) or the Globally Harmonized System (GHS), and is thus
considered to be not skin irritating in vitro.
In support of this notion, no skin irritation was observed in mice
topically treated with aluminium dihydrogen triphosphate in a skin
sensitisation study (Bradshaw, 2012). This suggests that the substance
is likely to be not skin irritating in vivo.
Based on the negative results of the above results from valid in
vitro skin corrosion and irritation studies, along with supporting
evidence from an in vivo skin sensitisation study, the test material
does not fulfil the criteria for classification according to Regulation
(EC) No 1272/2008 (CLP) and the Globally Harmonized System of
Classification and Labelling of Chemicals (GHS), and is thus considered
to be not skin irritating.
Eye corrosion (in vitro)
A Bovine Corneal Opacity and Permeability (BCOP) Assay was
conducted with aluminium dihydrogen triphosphate following OECD
Guideline 437 and in accordance with GLP (Warren, 2012). Three corneas
were treated with the test substance at 20% w/v in 0.9% w/v sodium
chloride solution for 240 min at 32 °C. Two groups of three corneas each
treated with 0.9% w/v sodium chloride and 20% w/v imidazole in 0.9% w/v
sodium chloride served as negative and positive controls, respectively.
Following opacity and permeability measurements, the in vitro irritancy
score was calculated.
The corneas treated with the negative control item were clear
post-treatment. The corneas treated with the positive control item were
cloudy post-treatment. The corneas treated with the test item were
slightly cloudy post-treatment. The in vitro irritancy scores of the
test substance-treated, negative and positive control corneas were 19.7,
3.9 and 87.7.
Therefore, the test material does not meet the criteria for
classification for Severe Eye Damage Category 1 according to Regulation
(EC) No 1272/2008 (CLP) or the Globally Harmonized System (GHS), and is
thus considered not to be an ocular corrosive or severe irritant in
Eye irritation (in vivo)
Aluminium dihydrogen triphosphate was tested for its irritancy
potential to the rabbit eye in a GLP-compliant study conducted according
to OECD Guideline 405 (Bradshaw, 2012). Two New Zealand White rabbits
were sequentially tested. In each case, 0.1 mL (ca. 98) mg of the test
material was placed into the conjunctival sac of one eye, the untreated
eye serving as control. The treated eyes were not rinsed after exposure,
and ocular effects were assessed at 1, 24, 48 and 72 h as well as 7 and
14 days post-instillation. Scattered or diffuse corneal opacity was
noted in one treated eye one hour after treatment, in both treated eyes
at the 24 and 48 h observations and in one treated eye at the 72 h
observation. Iridial inflammation was noted in both treated eyes one
hour after treatment and at the 24, 48 and 72 h observations and in one
treated eye at the 7-Day observation. Moderate conjunctival irritation
was noted in both treated eyes one hour after treatment and at the 24,
48 and 72 h observations with minimal conjunctival irritation noted at
the 7-Day observation. A small area of petechial haemorrhage on the
nictitating membrane was noted in one treated eye at the 24 and 48 h
observations. Both treated eyes appeared normal at the 14-Day
The test item produced individual scores of 1/0.67 for corneal
opacity, 1/1 for iritis, 2/2 for conjunctival redness and 1.67/2 for
chemosis, calculated as the mean scores following gradings at 24, 48 and
72 hour after instillation. Observed effects were fully reversible
within the observation period.
Therefore, the test item meets the classification criteria for Eye
Irritation Category 2 according to Regulation (EC) No 1272/2008 (CLP)
and for Eye Irritation Category 2A accoridng to the Globally Harmonised
System of Classification and Labelling of Chemicals (GHS).
The test item is thus considered to be eye irritating.
The available data indicates that the substance meets/does not meet the
classification criteria in accordance with Regulation (EC) No 1272/2008
(CLP) and Directive 67/548/EEC (DSD) as follows:
Skin irritation/corrosion: not classified
Eye irritation/corrosion: Eye Irrit. 2 (H319: Causes
serious eye irritation.)
Eye irritation/corrosion: Eye Irrit. 2A (H319: Causes
serious eye irritation.)
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