Reaction mass of aluminium fluoride and aluminium oxide and chromium (III) oxide and nickel dichloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

June - July 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted in accordance to well-described techniques

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Principles of method if other than guideline:

The method used in the present study to assess the pH and the Alkaline reserve was described in the following references:
- JF. Regnier and C. Imbert (1992). Contributions of physical-chemical properties to the evaluation of ocular irritation. Third SPTC Meeting, ATLA 20, 457-465.
- V. Froment (1993). Stage report, Elf Atochem SA. Evaluation du potentiel corrosif des produits chimiques par deux méthodes alternatives au test de Draize : Corrositex, Méthode physico-chimique.

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Name : REACTION MASS OF AlF3/CrF3/NiF2
Trade name: PBN1 Mixture
Chemical name: Aluminium fluoride / chromium trifluoride / nickel difluoride
CAS number: 7784-18-1 / 7788-97-8 / 10028-18-9
EC number: 914-309-1
Batch number/Supplier: 8204A
Date of reception in the test facility: 15/04/10
Expiration date of the test item: Not reported
Attributed GRL number: 0029/10
Main characteristics:
- Appearance: Solid green spheres (1-4 mm)
- Purity: 99.8%
- Expected water solubility: 0.5 g/L
- Relative density at 20°C: 3.0 at 20 °C
- Certificate of analysis reference: SFL-09-0001

Test animals

Species:

other: Not applicable

Strain:

other: Not applicable

Details on test animals or test system and environmental conditions:

Not applicable

Test system

Type of coverage:

other: Not applicable

Preparation of test site:

other: Not applicable

Vehicle:

other: Not applicable

Controls:

other: Not applicable

Amount / concentration applied:

Not applicable

Duration of treatment / exposure:

Not applicable

Observation period:

Not applicable

Number of animals:

Not applicable

Details on study design:

See "other information" below

Results and discussion

In vivo

Irritant / corrosive response data:

See "other information" below

Any other information on results incl. tables

Preliminary test

Aqueous PBN1 mixture shows an acidic character which is demonstrated by a pH of 4.92 for a 100 g/L solution in water.

A preliminary titration test showed that 1 N sodium hydroxyde allows good conditions for the alkaline reserve determination: 10 mL of the 100 g/L solution were neutralised by approximatively 2.9 mL of 1 N NaOH.

Definitive test

The definitive titration was performed 3 times in the following conditions :

A 20 mL volume of a 100 g/L solution is titrated by 0.1 N NaOH under permanent pH measurement .

Replicates gave following results :

 

 

Table 1:Results of neutralization experiments

 

Replicate	REACTION MASS OF AlF3/CrF3/NiF2at100 g/L, mL	NaOH 0.1 N, mL	Initial pH	Final pH	R*	Log(R)	I**
1	20	6.000	5.09	7.01	1.267	0.103	9.056
2	20	6.404	5.03	7.00
3	20	6.602	5.02	7.02

 

*R is the Alkaline reserve, expressed as number of grams of pure base to neutralise 100 g of test item.

 

** I is the physical-chemical index defined as follows : I = (14-pH )+ log R when pH is < 7

 

Conclusions

Under the test conditions, the results are as follows:

 

Test item	pH	log R	Physical-chemical index (I)
REACTION MASS OF AlF3/CrF3/NiF2	5.05	0.103	9.056

According to the method, the test item is considered:

- as potentially corrosive to the skin if at least 2 of the 3 following criteria are fulfilled:

·  pH≤ 2.5 or pH ≥9.5

·  log R ≥ 0

·  I≥ 10

As only 1 criteria is fulfilled, REACTION MASS OF ALF3/CRF3/NIF2 cannot be considered as potentially corrosive to the skin.

Applicant's summary and conclusion

Interpretation of results:

other: non potentially corrosive to the skin

Remarks:

Criteria used for interpretation of results: other: see detailed criteria in materials and methods "other information"

Conclusions:

According to the test results, reaction mass of ALF3/CRF3/NIF2 cannot be considered as potentially corrosive to the skin.

Executive summary:

The pH/alkaline reserve of the test item PBN1 mixture or REACTION MASS OF AlF₃/CrF₃/NiF₂(batch N° 8204A) was measured according to the method described in the two following references: JF. Regnier and C. Imbert (1992), and V. Froment (1993).

 

Under the test conditions, the results are as follows:

 

Test item	pH	log R	Physical-chemical index (I)
REACTION MASS OF AlF3/CrF3/NiF2	5.05	0.103	9.056

 

According to the method, the test item is considered:

 

- as potentially corrosive to the skin if at least 2 of the 3 following criteria are fulfilled:

·  pH≤ 2.5 or pH ≥9.5

·  log R ≥ 0

·  I≥ 10

As only 1 criteria is fulfilled, REACTION MASS OF AlF₃/CrF₃/NiF₂ cannot be considered as potentially corrosive to the skin .