Aluminum chloride, basic

Endpoint summary

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 for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

Qualifier:

according to guideline

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 or test system 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 for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

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.