Aluminium metaphosphate

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

Study for skin irritation in vivo has been performed prior to the 2016 update of the REACH Regulation.

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 May - 24 Jun 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Aluminium metaphosphate

EC Number:

237-415-3

EC Name:

Aluminium metaphosphate

Cas Number:

13776-88-0

Molecular formula:

Al.3HO3P

IUPAC Name:

aluminium metaphosphate

Details on test material:

- Name of test material (as cited in study report): Aluminium metaphosphate
- Physical state: white solid powder
- Analytical purity: >95%
- Lot/batch No.: B57053A
- Expiration date of the lot/batch: 11.10.2013
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

other: Zika

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kaninchenbetrieb Kock, Warnkenhagen, Germany
- Age at study initiation: 16-20 weeks
- Weight at study initiation: 3.30-4.43 kg
- Housing: single-caged
- Diet: conventional laboratory diet (a half-and-half blend of “Holzenstolz Kaninchenverbrauchsfutter 2, Type 038” [Wilhelm Stroeh jr. GmbH & Co. KG, Germany] and “Rabbit maintenance, MuesliMash” [ssniff Spezialdiäten GmbH, Germany]), ad libitum
- Water: tap water (drinking quality), ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

1 h

Observation period (in vivo):

5 days (2 animals) and 14 days (one animal)
Reading time points: 1, 24, 48, 72 and 96 h post-instillation

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The solid test substance had not been removed from the eyes of the test animals by physiological mechanisms at the first observation time point, therefore the treated eyes were rinsed with physiological saline.
- Time after start of exposure: 1 h

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: slit lamp biomicroscope / fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of all 3 animals

Time point:

other: mean from gradings at 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of all 3 animals

Time point:

other: mean from gradings at 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean from gradings at 24, 48 and 72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 96 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean from gradings at 24, 48 and 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 96 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean from gradings at 24, 48 and 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 96 h

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of all 3 animals

Time point:

other: mean from gradings at 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritant / corrosive response data:

1 h post-instillation: slight corneal opacity in 1/3 animals, no effects on iris, moderate conjunctival redness in 3/3 animals, slight chemosis in 3/3 animals
24 h: no corneal opacity, iritis or chemosis, slight and moderate conjunctival redness in 2 and 1 animals, respectively.
48 h: slight conjunctival redness in 3/3 animals
72 h: slight conjunctival redness in 3/3 animals
96 h: no ocular effects observed in any animal

Other effects:

No further local or systemic effects were observed.
There were no effects in body weight development.

Any other information on results incl. tables

Table 1. Summary of eye reactions

Eye reaction	Grading time point (after instillation)	Individual scores – Rabbit number and sex
		2013-16 female	2013-17 female	2013-18 female
Cornea	1 h	0	0	1
	24 h	0	0	0
	48 h	0	0	0
	72 h	0	0	0
	96 h	0	0	0
Mean score from gradings at 24, 48 and 72 h		0	0	0
Iris	1 h	0	-	-
	24 h	0	0	0
	48 h	0	0	0
	72 h	0	0	0
	96 h	0	0	0
Mean score from gradings at 24, 48 and 72 h		0	0	0
Conjunctivae	1 h	2	2	2
	24 h	2	1	1
	48 h	1	1	1
	72 h	1	1	1
	96 h	0	0	0
Mean score from gradings at 24, 48 and 72 h		1.3	1	1
Chemosis	1 h	1	1	1
	24 h	0	0	0
	48 h	0	0	0
	72 h	0	0	0
	96 h	0	0	0
Mean score from gradings at 24, 48 and 72 h		0	0	0

 

Table 2. Summary of body weight (gain)

Rabbit number and sex	Individual body weight (kg)		Body weight change (kg)
	Day 0	Day 5 or 14*
2013-17 female	3.30	3.53	+0.23
2013-18 female	4.43	4.83	+0.40
2013-26 female	4.16	4.61	+0.45

*Animal 2013-16 (initial test) was observed for 14 days, animals 2013-17 and 2013-18 (confirmatory test) were observed for 5 days post-instillation.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, the test material caused no eye irritating/corrosive reactions. The individual mean values from gradings at 24, 48 and 72 h were 0 for corneal opacity, iritis and chemosis in all 3 animals, and 1.3/1.0/1.0 for conjunctival redness in each animal. The observed effects were fully reversible within 96 h post-instillation. Therefore, the 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 eye irritating.

CLP: not classified
GHS: not classified