Aluminium trilactate

Endpoint summary

Description of key information

In an in vitro skin irritation test Aluminium trilactate was not irritating to the skin. In an eye irritation study (performed as Low volume eye test, LVET) Aluminium trilactate was irritating to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-07-02 to 2012-07-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Version / remarks:

24 August 2009

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Version / remarks:

adopted 22 July 2010

Deviations:

no

GLP compliance:

yes

Species:

other: not applicable, in vitro test

Strain:

other: not applicable, in vitro test

Details on test animals or test system and environmental conditions:

TEST SYSTEM
EPISKIN Small ModelTM (EPISKIN-SM, 0.38 cm², Batch no.: 12-EKIN-028), SkinEthic Laboratories, Lyon, France

On the day of receipt the tissues were transferred to 12-well plates and preincubated with prewarmed Maintenance Medium for 24 hours at 37°C.

All incubations, with the exception of the test substance incubation of 15 minutes at room temperature, were carried out in a controlled environment, in which optimal conditions were a humid atmosphere of 80 - 100% (actual range 83 - 98%), containing 5.0 ± 0.5% CO2 in air in the dark at 37.0 ± 1.0°C (actual range 36.3 - 37.7°C). Temperature and humidity were continuously monitored throughout the experiment. The CO2 percentage was monitored once on each working day.

Type of coverage:

open

Preparation of test site:

other: not applicable, in vitro test

Vehicle:

unchanged (no vehicle)

Remarks:

moistened with water

Controls:

other: not applicable, in vitro test

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10.2 to 12.1 mg, moistened with 5 µL water

Duration of treatment / exposure:

15 min

Observation period:

44 h

Number of animals:

not applicable, in vitro test

Details on study design:

negative control: 25 μL PBS
positive control: 25 μL 5% SDS in PBS
3 replicates of test substance, negative and positive control

After the exposure period of 15 minutes at room temperature, the tissues were washed with phosphate buffered saline to remove residual test substance. After rinsing the cell culture inserts were each dried carefully and moved to a new well on 2 mL pre-warmed maintenance medium until all tissues were dosed and rinsed. Subsequently the skin tissues were incubated for approximately 44 hours at 37°C.

After incubation, cell culture inserts were dried carefully to remove excess medium and were transferred into a 12-wells plate prefilled with 2 mL MTT-medium (0.3 mg/mL). The tissues were incubated for 3 h at 37°C. The amount of extracted formazan was determined spectrophotometrically at 570 nm in duplicate.
Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues. Skin irritation potential of the test substance was classified according to remaining cell viability following exposure of the test substance.

Irritation / corrosion parameter:

other: other: tissue viability

Value:

103

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 44 h. Reversibility: other: not applicable. (migrated information)

Irritant / corrosive response data:

The tissue viability after treatment with the test substance was 103% compared to the negative control.

Other effects:

not applicable

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

Aluminium trilactate is not irritating in the in vitro skin irritation test under the experimental conditions described in this report.

Executive summary:

In a dermal irritation study according to OECD Guideline 439 (In Vitro Skin Irritation), adopted 22 July 2010 and EU method B.46 (In vitro skin irritation: reconstructed human epidermis model test), 24 August 2009, Aluminium trilactate (93.0% a.i) was applied for 15 min to athree-dimensional human epidermis model (EPISKIN, SkinEthic Laboratories).

After the exposure period of 15 minutes at room temperature, the tissues were washed with phosphate buffered saline to remove residual test substance. Subsequently the skin tissues were incubated for approximately 44 h at 37°C. Cytotoxic (irritancy) was expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.

The relative mean tissue viability obtained after 15 minutes treatment with Aluminium trilactate compared to the negative control tissues was 103%.

Since the mean relative tissue viability for the test substance was above 50% after 15 minutes treatment, Aluminium trilactate is considered to be not irritating.

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:

1998-05-27 to 1998-06-08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

second updated version, adopted in 1987

Deviations:

yes

Remarks:

low volume eye test with 0.01 mL (0.006 g) of substance

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

dated 31 July 1992

Deviations:

yes

Remarks:

low volume eye test with 0.01 mL (0.006 g) of substance

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- SPF bred New Zealand White albino rabbits
- Age at study initiation: no data (young adult)
- Sex: male
- Weight at study initiation: 1955 – 2130 g
- Housing: individual in stainless steel cages with perforated floor
- Diet (e.g. ad libitum): standard laboratory rabbit diet ad libitum (SDS Special Diets services, Whitham, England)
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%):42.5-80% (upper limit higher than 70% because of wet cleaning of the animal room; 80% peak occurred for one hour at most)
- Air changes (per hr): ca 10
- Photoperiod (hrs dark / hrs light): 12 h dark/ 12 h light

IN-LIFE DATES: From: 27 May 1998 To: 8 June 1998

Vehicle:

unchanged (no vehicle)

Controls:

other: Left eye remained untreated and served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.01 mL (0.006 g), powdered

Duration of treatment / exposure:

eyes were not rinsed after treatment

Observation period (in vivo):

6 days

Number of animals or in vitro replicates:

3

Details on study design:

The test substance was powdered on cornea of the right eye. Eyelids were closed and held together for at least one second before releasing to prevent loss of material. Left eye remained untreated and served as control. Reactions were judged at 1 h, 24 h, 48 h, 72 h, and 6 days after treatment.
No washing.

SCORING SYSTEM: according to OECD 405

TOOL USED TO ASSESS SCORE: no tools mentioned

Irritation parameter:

cornea opacity score

Basis:

animal: 1

Time point:

other: mean 24, 48 and 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritation parameter:

cornea opacity score

Basis:

animal: 2, 3

Time point:

other: mean 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal: 1

Time point:

other: mean 24, 48 and 72 hours

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 6 days

Irritation parameter:

iris score

Basis:

animal: 2, 3

Time point:

other: mean 24, 48 and 72 hours

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal: 1, 2, 3

Time point:

other: mean 24, 48 and 72 hours

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 6 days

Irritation parameter:

chemosis score

Basis:

animal: 1, 2, 3

Time point:

other: mean 24, 48 and 72 hours

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritant / corrosive response data:

A minor corneal reaction was observed in one rabbit at 24 hours after treatment. Moderate to severe conjunctival effects were observed, but were fully reversible within 6 days.
In detail:
At 1 hour after treatment, slight iritis (one rabbit), slight redness and moderate or severe swelling of the conjunctivae, and slight or moderate ocular discharge were observed in the three rabbits.
At 24 hours after treatment, slight corneal opacity (one rabbit), slight iritis (one rabbit), moderate redness and moderate swelling of the conjunctivae, and slight or moderate ocular discharge were observed in the three rabbits.
At 48 and 72 hours after treatment, moderate redness and slight swelling of the conjunctivae, and slight or moderate ocular discharge were observed in the three rabbits.
At 6 days after treatment, all eye effects had cleared completely.

Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Timepoint	Cornea		Iris	Conjunctivae		Discharge
	score	area		redness	swelling
1 h	0/0/0	0/0/0	1/0/0	1/1/1	2/3/2	1/2/2
24 h	1/0/0	3/0/0	1/0/0	2/2/2	2/2/2	2/1/1
48 h	0/0/0	0/0/0	0/0/0	2/2/2	1/1/1	2/1/1
72 h	0/0/0	0/0/0	0/0/0	2/2/2	1/1/1	2/1/1
6 days	0/0/0	0/0/0	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0.3/0.0/0.0	Not calculated	0.3/0.0/0.0	2.0/2.0/2.0	1.3/1.3/1.3	Not calculated

 

Interpretation of results:

other: Category 2 (Irritating)

Remarks:

Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

In this study, Aluminium-L-lactate is irritating to the eye.
Interpretation is based on effects on the cornea, iris and conjunctiva calculated as mean scores following grading at 24, 48 and 72 hours after instillation of the test material, in consideration of reversibility.
The instillation of 0.01 mL of Aluminium-L-lactate onto the cornea of one eye of each of the animals resulted in a minor corneal reaction in one rabbit at 24 hours after treatment. Moderate to severe conjunctival effects were observed in all three animals. All effects were fully reversible within 6 days.

Executive summary:

In a primary eye irritation study according to OECD Guideline 405 (adopted 1987) and EU Method B.5 (dated 31 July 1992), performed as low volume procedure 0.01 mL (0.006 g) of Aluminium-L-lactate was placed directly on the cornea of three male White New Zealand rabbits. Animals then were observed for 6 days. Irritation was scored by the method of Draize as stipulated by OECD Guideline 405 with the addition of discharge scoring. The instillation of 0.01 mL of Aluminium-L-lactate onto the cornea of one eye of each of the animals resulted in a minor corneal reaction in one rabbit at 24 hours after treatment. Moderate to severe conjunctival effects were observed in all three animals. All effects were fully reversible within 6 days. A small amount of discharge was observed in all three animals, which had completely resolved within 6 days after instillation.

In this study, Aluminium-L-lactate is irritating to the eye.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Reliable, relevant and adequate data are available for the skin and eye irritation potential of Aluminium trilactate.

 

Skin irritation

In an in vitro dermal irritation study according to OECD Guideline 439 (In Vitro Skin Irritation), adopted 22 July 2010 and EU method B.46 (In vitro skin irritation: reconstructed human epidermis model test), 24 August 2009, Aluminium trilactate (93.0% a.i) was applied for 15 min to athree-dimensional human epidermis model (EPISKIN, SkinEthic Laboratories).

After the exposure period of 15 minutes at room temperature, the tissues were washed with phosphate buffered saline to remove residual test substance. Subsequently the skin tissues were incubated for approximately 44 h at 37°C. Cytotoxic (irritancy) was expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.

The relative mean tissue viability obtained after 15 minutes treatment with Aluminium trilactate

compared to the negative control tissues was 103%.

Since the mean relative tissue viability for the test substance was above 50% after 15 minutes treatment, Aluminium trilactate is considered to be not irritating.

 

Eye irritation

In a primary eye irritation study according to OECD Guideline 405 (adopted 1987) and EU Method B.5 (dated 31 July 1992), performed as low volume procedure 0.01 mL (0.006 g) of Aluminium-L-lactate was placed directly on the cornea of three male White New Zealand rabbits. Animals then were observed for 6 days. Irritation was scored by the method of Draize as stipulated by OECD Guideline 405 with the addition of discharge scoring. The instillation of 0.01 mL of Aluminium-L-lactate onto the cornea of one eye of each of the animals resulted in a minor corneal reaction in one rabbit at 24 hours after treatment. Moderate to severe conjunctival effects were observed in all three animals. All effects were fully reversible within 6 days. A small amount of discharge was observed in all three animals, which had completely resolved within 6 days after instillation.

In this study, Aluminium-L-lactate is irritating to the eye.

Justification for selection of skin irritation / corrosion endpoint:
only one study available

Justification for selection of eye irritation endpoint:
only one study available

Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the available reliable, relevant and adequate data, Aluminium trilactate does not need to be classified for skin irritation according to regulation (EC) 1272/2008 or the former European directive on classification and labelling 67/548/EEC.

Aluminium trilactate has to be classified as irritating to the eye (Category 2) according to regulation (EC) 1272/2008; no classification for eye irritation is required according to the former European directive on classification and labelling 67/548/EEC.