Registration Dossier

Administrative data

Description of key information

- Skin irritation/corrosion: not irritating (OECD 404, GLP, Kr: 1)
- Eye irritation: Causes serious eye damage (OECD 405, GLP, Kr: 1)
- Respiratory irritation: no data available

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:
22 to 25 February 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study well conducted.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd.
- Age at study initiation: approximately twelve to sixteen weeks old.
- Weight at study initiation: 2.24 - 2.68 Kg.
- Housing: individually
- Diet (e.g. ad libitum): Rabbit Diet, Preston Farmers Limited.
- Water (e.g. ad libitum): drinking water
- Acclimation period: five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21°C
- Humidity (%): 68 - 74%
- Air changes (per hr): 15 changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light.

IN-LIFE DATES: no data.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after the patches removal.
Number of animals:
Three (1 male and 2 females)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm gauze patch and placed in position on the shorn skin.
- % coverage: the patch was secured in position with a strip of surgical adhesive tape (BLENDER: approximate size 2.5 cm x 4.0 cm)
- Type of wrap if used: elasticated corset (TUBIGRIP)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize method.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
None
Other effects:
no data

Table 7.3.1/1: Individual Skin Reactions

Skin Reaction

Observation Time

(following patch

removal)

Individual Scores – Rabbit Number and Sex

145 Male

146 Female

148 Female

Erythema/Eschar

Formation

Immediately

0

0

0

1 h

0

0

0

24 h

0

0

0

48 h

0

0

0

72 h

0

0

0

Mean (24, 48 and 72 h)

0.0

0.0

0.0

Oedema

Formation

Immediately

0

0

0

1 h

0

0

0

24 h

0

0

0

48 h

0

0

0

72 h

0

0

0

Mean (24, 48 and 72 h)

0.0

0.0

0.0

 

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions of this study, the test material ALUM-17 was found to be non-irritant to the rabbit skin. Therefore, no classification is required according to EU criteria.
Executive summary:

In a primary dermal irritation study performed according to OECD Guideline 404 and in compliance with GLP, three New Zealand White rabbits were dermally exposed to 0.5 g of ALUM-17 as a powder (analytical purity of min. ) moistened with distilled water (0.5 mL) under a semi-occlusive dressing for 4 h. After removal of the residual test item, skin irritation was scored by the method of Draize (1959) at 24, 48 and 72 h after exposure.

No skin responses were noted during the study. All treated skin sites appeared normal at the 24 h observation. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0, 0 for erythema and 0, 0, 0 for oedema score, respectively. In this study, ALUM-17 is therefore not a skin irritant on rabbits.

Under the test conditions, Aluminium sulphate is not classified as irritating to skin according to the Regulation (EC) N° 1272 -2008 (CLP) and the Directive 67/548/EEC criteria.

.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

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:
From 5 to 29 March 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study well conducted.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd.
- Age at study initiation: twelve to sixteen weeks old.
- Weight at study initiation: 2.73 Kg.
- Housing: suspended metal cage.
- Diet (e.g. ad libitum): Rabbit diet, Preston Farmers Limited.
- Water (e.g. ad libitum): drinking water.
- Acclimation period: five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 59-63%
- Air changes (per hr): 15 changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light.

IN-LIFE DATES: no data.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:
single application (the eyelids were gently held together for one second). The other eye, remaining untreated, serves as a control.
Observation period (in vivo):
1, 24 and 48 hours following treatment.
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
- Time after start of exposure: not applicable.

SCORING SYSTEM: Draize scale.

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 and 48 hours
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: The animal was sacrificed for humane reasons following the 48 hour period of observation. Sloughing of the cornea was observed both at 24 and 48 hours.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 and 48 hours
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: The animal was sacrificed for humane reasons following the 48 hour period of observation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 and 48 hours
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: The animal was sacrificed for humane reasons following the 48 hour period of observation. White appearance of the nictitating membrane was observed both at 24 and 48 hours. Sloughing of the nictitating and conjunctival membranes were observed at 48 hours.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 and 48 hours
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: The animal was sacrificed for humane reasons following the 48 hour period of observation
Irritant / corrosive response data:
- A dulling of the normal lustre of the corneal surface was noted one hour after treatment. Diffuse corneal opacity was noted at the 24 and 48-hour observations.
- Iridial inflammation was noted one hour after treatment and at the 24 and 48-hour observations;
- Moderate conjunctival irritation was noted one hour after treatment and at the 24 and 48-hour observations.
- Other adverse ocular effects noted were sloughing of the cornea at the 24 and 48 - hour observations, pale appearance of the nictitating membrane one hour after treatment, white appearance of the nictitating membrane at the 24 and 48- hour observations and sloughing of the nictitating and conjunctival membranes at the 48-hour observation. The animal was killed for humane reasons following the 48-hour observation.
Other effects:
None.

Table 7.3.2/1: Mean irritant/corrosive response data of one treated animal at each observation time up to removal from the test:

Anim.

No.

Effect

Hours

Days after application

Mean

score cornea

Days

1/2

Mean score iritis

Days 1/2

 

Mean score redness Days 1/2/3

Mean score chemosis Days 1/2/3

1

1

2

 

80 Female

Cornea

 

 

Iris

 

Redness

 

 

Chemosis

4 (d)

 

 

1

 

2 (Pa)

 

 

3

2 (sl)

 

1

 

2 (W)

 

3

2 (sl)

 

1

 

2 (SL W)

3

2

 

 

 

 

 

1

 

 

 

 

 

2

 

 

 

 

 

 

 

 

3

D : dulling of the normal lustre of the corneal surface

Sl : sloughing of the cornea

Pa : pale appearance of the nictitating membrane

W : white appearance of the nictitating membrane

SL : sloughing of the nictitating and conjunctival membranes

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information (H318) Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions of this study, the test substance causes serious damage to eyes as corneal and conjunctival membrane sloughing and nictitating membrane whitening were observed. Therefore, ALUM-17 (17% Al2O3) was classified as corrosive to eyes according to EU criteria.
Executive summary:

In an eye irritation study performed similarly to the OECD test guideline No. 405 and according to GLP compliance, 0.1 g of ALUM-17 as powder was instilled into the conjunctival sac of one eye of only one female New Zealand rabbit. The other eye remained untreated served as control. Eyes were examined at 1, 24 and 48 hours following treatment and grading according to Draize scale.

A dulling of the normal lustre of the corneal surface was noted one hour after treatment following to a diffuse corneal opacity noted at 24 and 48-hours observations. Iridial inflammation and moderate conjunctival irritation were observed at 1, 24 and 48-hours observations. Other adverse effects included sloughing of the cornea up to 48 hours, pale appearance of the nictitating membrane one hour after treatment followed by white appearance of the nictitating membrane at 24 and 48-hour observations and sloughing of the nictitating and conjunctival membranes at 48-hours observation.The animal was sacrificed for humane reasons following the 48 hour period of observation.

Under the test conditions of this study, corneal and conjunctival membrane sloughing and nictitating membrane whitening were observed and considered as serious ocular effects. Therefore, ALUM-17 was classified as corrosive to eyes according to EU criteria.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

A key study was identified (Tuffnell, 1990). This study was performed according to OECD Guideline 404 and in compliance with GLP. Three rabbits were dermally exposed to 0.5 g of ALUM-17 as a powder (17% Al2O3) moistened with distilled water (0.5 mL) under a semi-occlusive dressing for 4 h. Skin irritation was scored by the method of Draize at 1, 24, 48 and 72 h after exposure.

No skin responses were noted during the study. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0, 0 for erythema and 0, 0, 0 for oedema score, respectively. Based on these results, Aluminum sulphate was considered to be non-irritant to skin.

Eye irritation:

A key study was identified (Dreher, 1990). This study was performed according to OECD Guideline 405 and in compliance with GLP. In this study, 0.1 g of ALUM-17 (17% Al2O3) as powder was instilled into the conjunctival sac of one eye of only one female New Zealand rabbit. The other eye remained untreated served as control. Eyes were examined at 1, 24 and 48 hours following treatment and grading according to Draize scale.

Corneal and conjunctival membrane sloughing and nictitating membrane whitening were observed and were not reversible. The animal was sacrificed for humane reasons following the 48 hour period of observation. Based on the results of this study, Aluminum sulphate was considered as corrosive to eyes.

Respiratory irritation:

No data available


Justification for selection of skin irritation / corrosion endpoint:
GLP Guideline study well conducted (Kr: 1). This study was identified as the key study because it was performed on Aluminum sulphate (purity: 99.98 % w/w as hydrated with 14H2O; corresponding/equivalent to 47-57 % w/w (typical purity : 52 % w/w) as anhydrous Al2(SO4)).

Justification for selection of eye irritation endpoint:
GLP Guideline study well conducted (Kr: 1). This study was identified as the key study because it was performed on Aluminum sulphate (purity: 99.98 % w/w as hydrated with 14H2O; corresponding/equivalent to 47-57 % w/w (typical purity : 52 % w/w) as anhydrous Al2(SO4)).

Effects on eye irritation: corrosive

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008 including ATP3.

Self classification:

Skin irritation/corrosion:

Based on the available data, the registered substance is:

- not classified according to the Regulation (EC) No. 1272/2008 as all scores for both erythema and oedema are 0.

- not classified according to the Directive 67/548/EEC as all scores for both erythema and oedema are 0.

Eye irritation:

Based on the available data, the registered substance is:

- classified into Category .1, H318 (causes serious eye damage) according to the Regulation (EC) No. 1272/2008 as serious ocular effects were observed and were not reversible.

- classified as corrosive to eyes Xi; R41 (risk of serious damage to eyes) according to the Directive 67/548/EEC as serious ocular effects were observed and were not reversible.

Respiratory irritation:

No classification is proposed due to lack of data.