Aluminium metaphosphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, 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:

15 Jul - 05 Aug 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 404 (Acute Dermal 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

Test animals

Species:

rabbit

Strain:

other: Zika

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kaninchenbetrieb Kock, Warnkenhagen, Germany
- Age at study initiation: reported as young adults
- Weight at study initiation: 3.13-4.85 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
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Remarks:

moistened with 500 µL water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 h

Observation period:

4 days
Reading time points: 1, 24, 48 and 72 h after patch removal

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: ca. 6 cm²
- Type of wrap if used: semiocclusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of the exposure period with water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema 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:

edema 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:

Immediately after patch removal (one animal only): no skin reactions were observed.
1-72 h: no skin reactions were observed in any animal at any obervation time point.

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 skin reactions

Skin reaction	Grading time point (after patch removal)	Individual scores – Rabbit number and sex
		2013-17 female	2013-18 female	2013-26 female
Erythema	Immediately	0	-	-
	1 h	0	0	0
	24 h	0	0	0
	48 h	0	0	0
	72 h	0	0	0
Mean score from gradings at 24, 48 and 72 h		0	0	0
Edema	Immediately	0	-	-
	1 h	0	0	0
	24 h	0	0	0
	48 h	0	0	0
	72 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 4
2013-17 female	3.54	3.59	+0.05
2013-18 female	4.85	4.89	+0.04
2013-26 female	3.13	3.21	+0.08

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the study, the test material caused no skin irritating/corrosive reactions. The individual mean values for erythema/eschar and edema from gradings at 24, 48 and 72 h were 0 in all three animals. 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 skin irritating.

CLP: not classified
GHS: not classified
DSD: not classified