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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

Additional information

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).

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