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

Endpoint summary

Description of key information

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).

The eye irritation study was conducted in year 1981and new assessed in year 1994.

All animals of each treatment group displayed slight or moderate initial pain responses on instillation of test material. Under the conditions of this assessment each of the three treatments elicited marked ocular irritation.

Therefore, the test item causes serious eye damage and will be classified as category 1 H318 according to Regulation 1272/2008/EEC (CLP).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

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

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

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

2.42

Reversibility:

not fully reversible within: 28 d

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.

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

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).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

method of the U.S. Federal Register, §191.12, 17 September 1964

Deviations:

not applicable

GLP compliance:

no

Remarks:

Study was performed under the control of a quality assurance unit similar to GLP

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Ranch Rabbits, Crawley Downi, Sussex
- Age at study initiation: 6 month
- Weight at study initiation: 4.08 - 5.60 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16+/-2
- Humidity (%): 50-70
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light): 10/14

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

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

Observation period (in vivo):

24, 48 and 72 h, 8 d

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
criteria of Draize as required by the U.S. Federal Register, §191.12, 17 September 1964

TOOL USED TO ASSESS SCORE: not reported

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

2.6

Max. score:

3

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

1.1

Max. score:

2

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

2.4

Max. score:

3

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

redness

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

2.7

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Reevaluation of data presented in the report was performed in year 1994.

A single instillation of 100 mg H 48 bleach caused marked irritation of the cornea and conjunctiva of all rabbits, and of the iris of three animals, 24 hours later. At that time corneal lesions ranged from easily discernible translucent areas to nacreous areas obscuring the iris and affected areas ranging from less than a quarter up to the entire corneal surface . Conjunctival reaction consisted of diffuse crimson and, in one instance, beefy-redness, chemosis, ranging from obvious swelling with partial evers ion of the lids to complete closure, and was usually accompanied by some degree of ocular discharge.
These reactions occasionally intensified up to 72 hours after administration and all, except the iridial reaction of three rabbits, persisted at Day 8. The iridial reaction of the latter had resolved between 72 hours and seven days after administration. On Day 8 all animals presented pannus, which in one instance obscured the iris.

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

H48 bleach showed severe irritation in the rabbit eye, when applied at doses of 100 mg. According to CLP GHS, H 48 bleach requires classification.

Executive summary:

The eye irritation study was conducted in year 1981and new assessed in year 1994.

All animals of each treatment group displayed slight or moderate initial pain responses on instillation of test material. Under the conditions of this assessment each of the three treatments elicited marked ocular irritation.

Therefore, the test item will be classified as eye irritant.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the irritation/corrosion data available, the substance will be classified as skin corrosion/irritation: Sub-category 1 C, H314 Causes severe skin burns and eye damage and

serious eye damage: Category 1 H318 Causes serious eye damage according to Regulation 1272/2008/EEC (CLP).