Aluminium trilactate

Eye irritation

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

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

Test guideline 2

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

Test material

Test material information

Constituent 1

Reference substance name:

Aluminium trilactate

EC Number:

242-670-9

EC Name:

Aluminium trilactate

Cas Number:

18917-91-4

Molecular formula:

C9H15AlO9

IUPAC Name:

Aluminium trilactate

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Aluminium-L-lactate

Test animals / tissue source

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

Test system

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

Results and discussion

In vivo

Results

Results 1

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

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal: 2, 3

Time point:

other: mean 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 3

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

Results 4

Irritation parameter:

iris score

Basis:

animal: 2, 3

Time point:

other: mean 24, 48 and 72 hours

Score:

0

Max. score:

2

Results 5

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

Results 6

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.

Any other information on results incl. tables

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

 

Applicant's summary and conclusion

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.