Reaction mass of sodium sulphate and trisodium trioxalatoferrate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

Early study, but reporting the main relevant details, No GLP, short report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: The Food and Drug Administration of the U.S .A. in The Federal Regi5ter (17 September 1964 § 191 .11)

GLP compliance:

no

Remarks:

pre-dates GLP

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of sodium sulphate and trisodium trioxalatoferrate

EC Number:

947-037-7

IUPAC Name:

Reaction mass of sodium sulphate and trisodium trioxalatoferrate

Test animals

Species:

rabbit

Strain:

not specified

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

0,5 g of test substance was mixed to a paste in water before application

Duration of treatment / exposure:

24 h

Observation period:

72 hours

Number of animals:

6

Details on study design:

All animals were treated on intact skin (left) and on abraded skin (right)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

mean

Time point:

other: 24 h

Score:

0.5

Max. score:

1

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

mean

Time point:

other: 24 h

Score:

0.166

Max. score:

1

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

Only 3 of 6 animals showed slight erythema on intact skin and 1 of these additionally a slight edema.

Other effects:

None

Any other information on results incl. tables

Animal	Effect	24 h	72 h
		Intact	intact
1	Erythema	0	0
	Edema	0	0
2	Erythema	0	0
	Edema	0	0
3	Erythema	1	0
	Edema	1	0
4	Erythema	0	0
	Edema	0	0
5	Erythema	1	0
	Edema	0	0
6	Erythema	1	0
	Edema	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Findings were not sufficient to warrant classification under 1272/2008 CLP

Executive summary:

0.5 g of the test item was mixed to a paste in water before application to the skin.

RESULT

Very slight erythema with and without and very slight to slight oedema was observed in three intact and six abraded sites at the 24 hours reading and three abraded sites at the 72 hours reading.

Findings were not sufficient to warrant classification under 1272/2008 CLP