Registration Dossier

Administrative data

Description of key information

- Skin irritation/corrosion: not irritating (OECD 404, GLP, K, rel: 1)

- Eye irritation: Causes serious eye damage (OECD 405, GLP, K, rel: 2)

- 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:
21 January 1986 - 24 January 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study was performed according to OECD guideline 404 and under GLP conditions.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Directive 84/449/EEC
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Remarks:
Statement of Compliance
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breed
- Age at study initiation: ca. 3 - 5 months
- Weight at study initiation: 3.1 - 3.4 kg
- Housing: Individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): Fully airconditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,5 ml
- Concentration (if solution): 100 % (undiluted)
Duration of treatment / exposure:
4 hours
Observation period:
30 and 60 min, and 24, 48 and 72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Approx. 24 hours prior to the start of the experiment 3 rabbits were depilated in the dorsal region of the trunk with an electric hair clipper on an area of approx. 25 cm2. Only animals with intact skin were used. Each animal was fixed on the prepared skin site with a wound plaster with 2.5 x 2.5 cm. The area was covered with a semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): remaining test substance removed with lukewarm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM: subjective numerical according to OECD Guideline 404 (Erythema and Eschar formation / Oedema formation). Maximum possible score: 4
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
Mean Individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
Mean Individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritant/corrosive response
Other effects:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions of this study, the test material Povimal was found to be non-irritant to the rabbit skin. Therefore, no classification is required according to the Regulation (EC) N° 1272/2008 (CLP) and the GHS.
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 ml of Aluminiumhydroxichloride (undiluted) under a semi-occlusive dressing for 4 h. After removal of the residual test item, skin irritation was scored by the method of Draize 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, Povimal is therefore not a skin irritant on rabbits.

 

Under the test conditions, Aluminiumhydroxichloride is not classified as irritating to skin according to the Regulation (EC) N° 1272/2008 (CLP) and the GHS.

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:
April 1996 - May 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Information on substance identity and composition is lacking. Batch No. is given, guideline 405 is followed and study is performed according to GLP.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
: age of animals is not mentioned
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: Elevage Cunicole de Val de Selle, France
- Age at study initiation: no data
- Weight at study initiation: on the day of treatment 2.3 ± 0.1 kg
- Housing: Individual housing
- Diet (e.g. ad libitum): free access to pelleted diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 to 70
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12h/12h


IN-LIFE DATES: From: April 25, 1996 To: May 16, 1996
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml into the left eye
- Concentration (if solution): test article was used in its original form


VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable
Duration of treatment / exposure:
single application into the left eye (the lower and upper eyelids were held together for about one second to avoid any loss of test substance. The right eye served as control). The eyes were not rinsed
Observation period (in vivo):
- approximately 1 hour and 24, 48 and 72 hours after administration
- when there is persistent ocular irritation after 72 hours the observation period is extended to a maximum of 21 days (until day 22)
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eyes were not rinsed
- Time after start of exposure: not applicable


SCORING SYSTEM: see below (Table 7.3.2/1)


TOOL USED TO ASSESS SCORE:
- Cornea: 2 drops of 0.5% sodium fluorescein solution; direct examination or, if necessary, with an Ultra-Violet lamp
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
probability of severe irritation
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 21 days.
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
Mean individual score
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
No ocular corrosion mentioned.
Other effects:
- One animal was killed on day 12. This animal showed also white spots on the conjunctivae, alopecia around the eye and neovascularisation.
- The two other animals also showed alopecia and neovascularisation.

Table 7.3.2/2: Summary of ocular lesions:

Anim.

No.

Effect

Hours

Days after application

Mean

score cornea

Days

1/2/3

Mean score iritis

Days 1/2/3

 

Mean score redness Days 1/2/3

Mean score chemosis Days 1/2/3

1

1

2

3

7

14

21

01

Cornea

Iris

Redness

Chemosis

0

0

0

2

1

1

3

3

1

1

3

2

1

1

3

2

1

1

3

1

1

1

2

1

1

0

0

0

1

 

1

 

 

3

 

 

 

2.33

02

Cornea

Iris

Redness

Chemosis

0

0

0

2

1

1

2

3

2

1

2

3

2

1

2

3

3

1

2

3

-

-

-

-

-

-

-

-

1.67

 

1

 

 

2

 

 

 

3

03

Cornea

Iris

Redness

Chemosis

0

0

0

2

2

0

3

3

2

1

3

2

1

1

3

2

1

1

3

2

0

0

0

1

/

/

/

/

1.67

 

0.67

 

 

3

 

 

 

2.33

Mean all anim.

 

 

 

 

 

 

 

 

 

 

1.45

 

0.89

 

2.67

 

2.55

- Animal killed

/ Ocular examination not performed on day 21, because effects were gone on day 19

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the test conditions of this study, it was concluded that the test compound, Aqualenc E, induced a severe eye irritation. The eye effects weren’t completely reversible within 21 days. Furthermore, one animal was killed due to severe eye effects. Therefore, the product is classified in Category 1 (H318: causes serious eye damage) according to the CLP Regulation (1272/2008) and the GHS.
Executive summary:

In an eye irritation study performed according to OECD test guideline No. 405 and in compliance with GLP, 0.1 ml of Aqualenc E (17% Al2O3) was instilled into the conjunctival sac of one eye of three New Zealand white rabbits. The other eye of each rabbit served as control. Eyes were examined at 1, 24, 48 and 72 hours and 21 days following treatment and grading according to Draize scale.

Individual mean scores at 24, 48 and 72 h after exposure were 1, 1.67, 1.67 for corneal lesions, 1, 1, 0.67 for Iris lesions, 3, 2, 3 for conjunctival redness and 2.33, 3, 2.33 for chemosis respectively. The eye effects weren’t completely reversible within 21 days. Furthermore, one animal was killed due to severe eye effects. Therefore, the product causes irreversible effects on the eye.

Under the test conditions, Aluminium hydroxide chloride, low basicity is classified in Category 1 according to the CLP Regulation (1272/2008) and the GHS.

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 (Hofmann, 1986). This study was performed according to OECD Guideline 404 and in compliance with GLP. Three rabbits were dermally exposed to 0.5 ml of Aluminiumhydroxychloride (undiluted) under a semi-occlusive dressing for 4 h. After removal of the residual test item, skin irritation was scored by the method of Draize at 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, Aluminiumhydroxychloride was considered to be non-irritant to skin.

Eye irritation:

A key study was identified (Jouffrey, 1996). This study was performed according to OECD Guideline 405 and in compliance with GLP. In this study, 0.1 ml of Aqualenc E (17% Al2O3) was instilled into the conjunctival sac of one eye of three New Zealand white rabbits. Eyes were examined at 1, 24, 48 and 72 hours and 21 days following treatment and grading according to Draize scale.

 

Individual mean scores at 24, 48 and 72 h after exposure were 1, 1.67, 1.67 for corneal lesions, 1, 1, 0.67 for Iris lesions, 3, 2, 3 for conjunctival redness and 2.33, 3, 2.33 for chemosis respectively.The eye effects weren’t completely reversible within 21 days. Furthermore, one animal was killed due to severe eye effects. Therefore, the product is classified in Category 1 - causes irreversible damages to the eyes.

 

Respiratory irritation:

No data available

Justification for classification or non-classification

Harmonized classification:

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

Self classification:

Skin irritation/corrosion:

Based on the available data, the substance is:

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

Eye irritation:

Based on the available data, the substance is classified into Category 1, H318 (causes serious eye damage) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

Respiratory irritation:

No classification is proposed due to lack of data.