Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)

EC Number:

279-013-0

EC Name:

Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)

Cas Number:

78948-87-5

Molecular formula:

C16H8MgO10.2H

IUPAC Name:

Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)

Test animals

Species:

rabbit

Strain:

other: SPF albino Chbb:HM(SPF) - Littlerussian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BI Pharma KG, 88397 Biberach
- Age at study initiation: age not indicated
- Weight at study initiation: 2.3 – 2.7 kg
- Housing:
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 55+/- 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Remarks:

A 10 x 10 cm dorsal area of the trunk was clipped with an electric clipper. Two 2,5 cm x 2.5 cm gauze patches with each 0.5 g of the test item were fixed with adhesive tape at two sites (left and right) within the clipped area.

Vehicle:

other: Native oil (sunflower oil)

Controls:

other: Non-treated areas at the same animals were used as controls.

Amount / concentration applied:

0.5 g of applied test substance was moistened with 0.1 mL of the vehicle.
1 g/animal (2 x 0.5 g)

Duration of treatment / exposure:

Duration of exposure 4 h

Observation period:

Postexposure period 28 d

Number of animals:

3 females

Details on study design:

Test site and Preparation of Test Site: A 10 x 10 cm dorsal area of the trunk was clipped with an electric clipper. Two 2,5 cm x 2.5 cm gauze patches with each 0.5 g of the test item were fixed with adhesive tape at two sites (left and right) within the clipped area.

Removal of test substance: Water and mild soap

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

2.42

Reversibility:

not fully reversible within: 28 d

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

2.5

Reversibility:

not fully reversible within: 14 d

Irritant / corrosive response data:

Severe skin reactions were observed at the rabbits. Even at the end of the observation period, one animal showed irreversible effects.
The third animal showed a complete destruction of the skin on the whole patch area , therefore a scoring was not possible.

Any other information on results incl. tables

Table for skin irritation
score (average animals investigated)	Time after exposure	Erythema	Oedema
average score of two animals (in one animal scoring was not possible; see 4.3) (0 to maximum 4)	1 h	3	2.75
	24 h	2.25	2.5
	48 h	2.5	2.5
	72 h	2.5	2.5
average score	24h, 48h, 72h	2.42	2.5
reversibility: *		n c	n c
average time for reversibility		28 d	14 d.
*     c :     completely reversible     n c :     not completely reversible        n :     not reversible

Applicant's summary and conclusion

Interpretation of results:

Category 1C (corrosive) based on GHS criteria

Conclusions:

The animals showed moderate to severe skin reactions which were only partial reversible. One animal showed a complete destruction of the skin on the whole patch area.
Based on the irritation/corrosion data available, the substance will be classified as skin corrosion/irritation: Sub-category 1 C, H314 according to Regulation 1272/2008/EEC (CLP).

Executive summary:

The potential for acute skin irritation of Magnesium-monoperoxyphthalat was investigated according to the OECD Guideline 404 “Acute Dermal Irritation/Corrosion”, 1992 and EEC Guideline B.4 “Acute toxicity (Skin -irritation/Corrosion)”, Jan 1997. Three female rabbits (strain Chbb:HM(SPF) – Littlerussian) received an amount of 0.5g each of the test item on the left and right dermal side of the trunk. The exposure duration was 4 hours under semioccclusive conditions. The skin was assessed for signs of irritation 1h, 24h, 48h, 72h , 7 d, 14 d, 21 d and 28 d after administration. The animals showed moderate to severe skin reactions which were only partial reversible. One animal showed a complete destruction of the skin on the whole patch area. Based on the irritation/corrosion data available, the substance will be classified as skin corrosion/irritation: Sub-category 1 C, H314 according to Regulation 1272/2008/EEC (CLP).