Acacia mearnsi, ext., reaction products with ammonium chloride and formaldehyde

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 21/07/2006 to 02/08/2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted according to GLP compliance and International Guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Observation period was only 7 days long instead 21 days

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

ACQUAPOL C1

IUPAC Name:

ACQUAPOL C1

Test material form:

other: liquid

Details on test material:

Test article: ACQUAPOL C1
stated chemical composition: Aqueous solution of quaternary ammonium tannate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Test system:
Adult white albino rabbits (Oryctolagus cuniculus) of the New Zealand breed, weighing 1850-2200 gramsof live weigh, were used. the animals were healty and had no detectable pathological changes in the eyes.
Environmental condition:
The animals were acclimated to the laboratory conditions at least 5 days prior to the beginning of the experiment. They were kept with ventilation of 10 to 15 air changes per room per hour and a photoperiod of 12 hours in the light and 12 hours in the dark. The diet comprised commercial pelletized feed, with supplemetnation of filtered water, both provided ad libitum. 3 animals were used, 3 males, which were kept individually in galvanized wire cages.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

The test article Acquapol C1, originally in liquid form, was used pure. The total amount of the solution applied to the skin in each animal was 0.1 ml

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

Approximately 24 hours before the beginning of the test, the animals' eyes to be tested were examinated for the detection of any undesirable change that might exists and render the animal useless for the test. The total volume of the solution was installed onto the conjunctival sac of the left eye, after midly separating both eyelids and subsequently keeping them together for a few seconds.The untreated right eyes was used as negative control.
In the end of the treatment period (after 24 hours), the residue from the applied solution was removed with a physiological solution. The animals so treated were maintained for a maximum period of 7 days following the application and were observed at 1, 24, 48, 72 hours and 7 days for the presence of lesions on the cornea, iris and palpebral and bulbar conjunctivae, as well as other severe local and general alterations.

Analysis of the results:
Each animal was separately evaluated and their results were put into individual tables. The degrees of eye lesions were recorded in accordance with the scale in Table 1

Calculation of the eye irritation index:
Cornea: A x B x 5 (Maximum total = 80)
Iris: A x 5 (Maximum toal = 10)
Conjunctivae: (A + B + C) x 2 (Maximum total = 20)

To estabilish the Eye Irritation Index, the values for cornea, iris and conjunctivae at the respective reading time, obtained through the above formulas, were failled. After obtaining the average reading time for the number of rabbits used, the highest index estabilished was used to classify the product according to the criteria in table 2

Results and discussion

In vivo

Results

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 48 hours

Score:

ca. 27

Reversibility:

not fully reversible within: 7 days

Irritant / corrosive response data:

Eye Irritability Index: For 48 hours: 27.0
Classification: Class II (Moderately Irritating): Opacity of the cornea and persistent iritis for 7 days, moderate hyperemia of conjunctiva.

Any other information on results incl. tables

Annex 1: Degree of eye lesions in the animals for the product ACQUAPOL C1.

Rabbit n.1
Cornea		Iris	Conjunctiva			Time
0	0	0	3	3	2	1 hour
0	0	1	3	3	2	24 hours
0	0	1	3	3	2	48 hours
0	0	1	2	2	2	72 hours
0	0	0	2	2	2	7 days
Rabbit n.2						-
Cornea		Iris	Conjunctiva			Time
0	0	0	3	3	2	1 hour
1	1	1	3	4	3	24 hours
1	1	1	3	4	3	48 hours
0	0	1	3	3	2	72 hours
0	0	0	2	2	2	7 days
Rabbit n.3
Cornea		Iris	Conjunctiva			Time
1	1	0	2	3	3	1 hour
1	1	0	3	4	3	24 hours
1	1	1	3	4	3	48 hours
1	1	1	3	4	3	72 hours
2	2	2	3	4	3	7 days

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The substance Acacia Mearnsi (ACQUAPOL C1) was considered moderately irritant when applied to the eyes in rabbits accordin to the regulation 1272/2008/CE.

Executive summary:

A primary Eye Irritation Test, was conducted on rabbits to study the potential damage effects, reversible or not, of Acacia Mearnsi (ACQUAPOL C1), on the eyes of superior animals. The product was used pure and applied to the conjuctival sac of the left eye of the rabbits at a total volume of 0.1 mL. The animals so treated were mantained for 7 days following the application and observed for the presence of lesion on the eyelid and eyeball mucosae, as well as other severe local and general alterations.

An eye irritation Index of 27.0 was observed on a scale of 110.

The product ACQUAPOL C1 was considered moderately irritating when applied to the eyes in rabbits.