Registration Dossier

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Administrative data

Description of key information

SKIN

Hagermann (1992) (% composition of substance in test material: 70:30), K1

Under the experimental conditions employed TK 10315/S induced erythema and oedema reactions when applied to the clipped albino rabbit skin.

The reactions were reversible until the reading of 10 days after application.

EYES

- In vitro

Prinsen (2009) (% composition of substance in test material: 97.9%), K1

The negative control eye showed no corneal effects. The positive control caused moderate swelling, severe opacity and severe fluorescein retention. The calculated Irritation Index was 149. Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) caused very slight swelling, very slight opacity and very slight fluorescein retention. The calculated Irritation Index was 22.

On the basis of the results obtained in the ICE test and according to its classification schemes, Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) was considered not irritating to eyes.

- In vivo

Prinsen (2010) (% composition of substance in test material: 97.9%), K1

At 1, 24, 48 and 72 hr after treatment, no signs of irritation were observed in the rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1st September 1992 - 11th September 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Age at study initiation: NDA
- Weight at study initiation: 2350 - 2670 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark


IN-LIFE DATES: From: 1st September 1992 To: 11th September 1992
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: control patch on left side of the animal.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): N/A


VEHICLE
- N/A
Duration of treatment / exposure:
4 hours
Observation period:
10 days.
Skin observations recorded at 1, 24, 48 and 72 hours according to the OECD scoring system.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 12 - 16 cm²
- % coverage: NDA
- Type of wrap if used: gauze patch covered with aluminium foil


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not performed
- Time after start of exposure: N/A


SCORING SYSTEM: OECD 404 scoring system
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: All three animals are a erythema score mean of 2
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: All three animals are a erythema score mean of 1
Irritant / corrosive response data:
Because reactions were observed within 7 days after removing the bandages, the observation period was extended to 10 days to determine the reversibility of the skin reactions. Scaling was observed in all animals on day 7.
The skin reactions observed were reversible until the end of the observation period on day 10.
Other effects:
None

Table 1. Individual skin reaction scores.

  Erythema Edema
Animal number 738/F
CF/TF
856/F
CF/TF
720/F
CT/TF
738/F
CF/TF
856/F
CF/TF
720/F
CT/TF
After 1 hours 0/2 0/2 0/2 0/1 0/1 0/2
After 24 hours 0/2 0/2 0/2 0/1 0/1 0/1
After 48 hours 0/2 0/2 0/2 0/1 0/1 0/1
After 72 hours 0/2 0/2 0/2 0/1 0/1 0/1
Mean 24-72 hours 0/2 0/2 0/2 0/1 0/1 0/1
After 7 days 0/1s 0/1s 0/1s 0/0 0/0 0/0
After 10 days 0/0 0/0 0/0 0/0 0/0 0/0

Table 2. Individual bodyweights.

Animal number 738/F 856/F 720/F
At start of test 2350 2670 2560
After 3 days 2360 2780 2500
After 7 days 2470 2900 2700
After 10 days (end) 2580 2990 2750
Interpretation of results:
other: not classified according to EU criteria
Conclusions:
Under the experimental conditions employed TK 10315/S induced erythema and oedema reactions when applied to the clipped albino rabbit skin.
The reactions were reversible until the reading of 10 days after application.
Executive summary:

TK 10315/S (Mono-n-octyl-tin-tris-(2-ethylhexylmercaptoacetate)) was applied to the skin female New Zealand White rabbits via an occlusive patch. The test was conducted according to OECD 404 and performed to GLP. The patch was applied for 4 hours and the rabbits were then observed for 10 days.

Under the experimental conditions employed TK 10315/S induced erythema and edema reactions when applied to the clipped albino rabbit skin.

The reactions were reversible until the reading of 10 days after application.

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27th November - December 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
chicken
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Heads of the animals were obtained from poultry slaughterhouse v.d. Bor, Amersfoortseweg 118, Nijkerkerveen, the Netherlands.
- Age at study initiation: in vitro study, eyes from 7 week old chicks were used.
- Weight at study initiation: 1.5 - 2.5 kg


ENVIRONMENTAL CONDITIONS
not applicable.
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µL
- Concentration (if solution): N/A


VEHICLE
not applicable.
Duration of treatment / exposure:
10 seconds
Observation period (in vivo):
Approximately 30 minutes after treatment observations were recorded
Number of animals or in vitro replicates:
in vitro study:
1 negative control eye.
3 positive control eyes
3 test eyes
Details on study design:
EXPERIMENTAL DESIGN
Within 2 hours after kill, eyes were carefully dissected and placed in a superfusion apparatus (see Figure 1) using the following procedure: First the eye lids were carefully removed without damaging the cornea and a small drop of Fluorescein sodium BP 2.0% w/v (Minims, Smith & Nephew Ltd., Romford, England) was applied to the corneal surface for a few seconds and subsequently rinsed off with isotonic saline at ambient temperature. Next, the head with the fluorescein treated cornea were examined with a slit lamp microscope (Slit lamp 900 BP, Haag Streit AG, Liebefeld Bern, Switzerland) to ensure that the cornea is not damaged. If undamaged, the eye was further dissected from the head without damaging the eye or cornea. Care was taken to remove the eye ball from the orbit without cutting off the optical nerve too short.

The enucleated eye was placed in a stainless steel clamp with the cornea positioned vertically and transferred to a chamber of the superfusion apparatus (TNO, Zeist, the Netherlands). The clamp holding the eye was positioned in such a way that the entire cornea was supplied with isotonic saline from a bent, stainless steel tube, at a rate of ca 0.10 0.15 mL/min (peristaltic pump set at 5.00, Watson-Marlow 205CA, Rotterdam, the Netherlands). The chambers of the superfusion apparatus as well as the saline were temperature controlled at approximately 32ºC (water pump set at 34ºC; Lauda 103, Germany).

After placing in the superfusion apparatus, the eyes were examined again with the slit lamp microscope to ensure that they are not damaged. Corneal thickness was measured using the Depth Measuring Attachment No. I for the Haag Streit slit lamp microscope. Corneal thickness was expressed in instrument units. An accurate measurement was taken at the corneal apex of each eye.

Eyes with a corneal thickness deviating more than 10% of the average corneal thickness of the eyes, eyes that show opacity (score higher than 0.5), or are unacceptably stained with fluorescein (score higher than 0.5) indicating the cornea to be permeable, or eyes that show any other signs of damage, were rejected as test eyes and replaced.

In accordance with the proposed OECD guideline no. 438, three test eyes, one negative control eye and three positive control eyes were selected for testing. Each eye provided its own baseline values for corneal swelling, corneal opacity and fluorescein retention. For that purpose, after an equilibration period of 45 60 minutes, the corneal thickness of the eyes was measured again to determine the zero reference value for corneal swelling calculations.
At time t = 0 (i.e. immediately after the zero reference measurement), the following procedure was applied for each test eye: The clamp holding the test eye was placed on paper tissues outside the chamber with the cornea facing upwards. Next, the eyes (corneas) were treated with the study substances 30µl for 10 seconds, followed by rinsing in 20ml saline.After rinsing, each eye in the holder was returned to its chamber.

The eyes were examined at ca 0, 30, 75, 120, 180 and 240 minutes after treatment, using the criteria and scoring system given in Annex 1. Fluorescein retention was only scored at ca 30 minutes after treatment. All examinations were carried out with the slit lamp microscope.
After the final examination the test substance treated eyes and the negative and positive control eyes were preserved in a neutral aqueous phosphate buffered 4% solution of formaldehyde. The corneas were embedded in paraffin wax, sectioned at 5 µM and stained with PAS (Periodic Acid-Schiff). The microscopic slides were filed in the archives and kept available for histopathological examination if considered relevant. In the case of Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE), histopathological examination was considered not relevant, because no significant corneal effects were observed.

CONTROLS
- Positive control: 5% (w/w) aqueous dilution of benzalkonium chloride
- Negative control: Saline.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with 20 mL of saline solution
- Time after start of exposure: 10 seconds


SCORING SYSTEM:
In the ICE test, the eyes were examined at several time intervals after treatment to determine ocular effects using the parameters of corneal thickness (swelling), corneal opacity and fluorescein retention. Defined scoring scales were used for each parameter to define the severity of effects into four categories (I-IV). Four classes of eye irritancy (not irritating; slightly irritating; moderately irritating; severely irritating) were identified in the ICE test by combination of the categories defined for each of the evaluation parameters using the Prediction Model described in the box below.
Regulatory classification of eye irritants was based on the standard in vivo Draize Eye test. Various international regulatory classification systems are in use. Some systems recognize four classes, viz. non irritant, mild irritant (Category 2B), irritant (Category 2A), and severe irritant (Category 1) such as in the Globally Harmonized System (UN/GHS). The new EC Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) entered into force on the 20 January 2009. CLP implements the Globally harmonised System (GHS). The EC/GHS-classification system (CLP) recognizes three classes, i.e. non-classified/non-irritant (NC/NI), irritant (Category 2) and severe irritant (Category 1).
Table 1 below shows the criteria used in the EC/GHS-regulatory classification system to identify the different classes of eye irritants

In order to translate the eye irritancy scores from the ICE test to an EC/GHS-regulatory classification, it was necessary to reconcile four irritancy classes from the ICE study into three classes within the EC/GHS-regulatory classification scheme. This was achieved through application of the prediction model defined below, which was based on scientific judgement and which was supported by several years of experience with conduct of the ICE test in parallel to the in vivo OECD 405 test. As a result of the reconciliation of the four ICE classes of irritancy into the 3 classes of the EC/GHS-regulatory classification system, it is possible that materials defined as slightly irritant using the ICE test Prediction Model may be identified in the EC-regulatory classification system as not classified/non-irritant.

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein
Irritation parameter:
in vitro irritation score
Run / experiment:
Test material
Value:
22
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Remarks:
no effects
Positive controls validity:
valid
Remarks:
Irritation Index = 149

Table 2: Summary of Results

Test material

 

Maximum mean score for:

Irritation

categories1

Irritation

Index2

Classification

(General, GHS and EC/GHS)

Swelling %

Opacity

Fluorescein

retention

MOTE

2

0.5

0.5

I;I;I

22

NI/NI/NI

BAC 5%

295

3.0

3.0

III;IV;IV

149

severe/I/I

Saline (negative control)6

0

0.0

0.0

n.a.7

n.a.

n.a.

1        I = no effect; II = slight effect; III = moderate effect; IV = severe effect.

2        Irritation Index = maximum mean corneal swelling + maximum mean opacity (x 20) + mean fluorescein score (x 20).

3        2B = mild irritant; 2A = irritant; 1 = serious eye damage. United Nations-Economic Commission for(UN/ECE) (2003). Globally Harmonised System of Classification and Labelling of Chemicals (GHS). UN,and, 2007 (http://www.unece.org/trans/danger/publi/ghs/ghs_rev02/02files_e.html)

4        Blistering of epithelium.

5        Individual values based on one eye.

6 n.a. = not applicable

EC/GHS‑CLASSIFICATION (CLP) OF EYE IRRITANTS; EXTRAPOLATION FROM IN VITRO RESULTS TO IN VIVO CLASSIFICATION.

 

Extrapolation from thein vitroirritancy results to the EC/GHS classification will be carried out using scientific judgement, re-dividing the original four irritancy classes to three. The combinations of the three categories that are allowed for each of the three classifications are mentioned in the scheme below.

 

Regulatory Classification Combinations of the three categories.

NC/NI = not classified/not irritating            3 x I

                                                                          2 x I, 1 x II

                                                                          2 x II, 1 x I3

 

EC/GHS Category 24:                                    3 x II

Irritating to eyes                                             2 x II, 1 x III

                                                                          1 x I, 1 x II, 1 x III¹

                                                                          3 x III

                                                                          2 x III, 1 x II

                                                                          2 x III, 1 x I

                                                                          2 x I, 1 x IV¹

                                                                          2 x II, 1 x IV¹

                                                                          2 x III, 1 x IV2

                                                                          1 x II, 1 x III, 1 x IV¹

 

EC/GHS Category 14:                                     3 x IV

Irreversible effects on the eye/                     2 x IV, 1 x III

serious damage to eyes                                 2 x IV, 1 x II¹

                                                                          2 x IV, 1 x I¹

                                                                          immediate corneal opacity score 3

                                                                          corneal opacity score 4

                                                                          severe loosening of epithelium

¹ Combinations of categories less likely to occur.

 2The combination of 2 x III, and 1 x IV can be considered as a borderline case between irritating and severely irritating.

 3The combination of 2 x II, and 1 x I can be considered as a borderline case between not irritating and Category 2.

 4Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.

 

Interpretation of results:
other: not classified according to EU criteria
Conclusions:
The negative control eye showed no corneal effects. The positive control caused moderate swelling, severe opacity and severe fluorescein retention. The calculated Irritation Index was 149. Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) caused very slight swelling, very slight opacity and very slight fluorescein retention. The calculated Irritation Index was 22.

On the basis of the results obtained in the ICE test and according to its classification schemes, Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) was considered not irritating to eyes.
Executive summary:

Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) was evaluated neat in the Isolated Chicken Eye (ICE) test, according to OECD guideline no. 438. Chicken eyes were obtained from slaughter animals used for human consumption. The isolated chicken eyes were exposed to a single application of the test sample for 10 seconds using an application volume of 30 µL. Benzalkonium chloride (BAC) 5% was used as the positive control and physiological saline as the negative control. Three main parameters were measured to disclose possible adverse eye effects: corneal thickness (expressed as corneal swelling), corneal opacity and fluorescein retention of damaged epithelial cells.

The negative control eye showed no corneal effects. The positive control caused moderate swelling, severe opacity and severe fluorescein retention. The calculated Irritation Index was 149. Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) caused very slight swelling, very slight opacity and very slight fluorescein retention. The calculated Irritation Index was 22.

On the basis of the results obtained in the ICE test and according to its classification schemes, Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) was considered not irritating to eyes.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26th January 2010 - 29th January 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River, France
- Age at study initiation: young
- Weight at study initiation: 2148, 1958 and 2179 g
- Housing: individually in cages, fitted with a perforated floor (Rack Multifloor pen system, 785x840x450 mm) with cage enrichment.
- Diet (e.g. ad libitum): Standard laboratory diet ad libitum.
- Water (e.g. ad libitum): Tap water (N.V. Vitens) ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 ºC
- Humidity (%): 45 - 70 %
- Air changes (per hr): 10 air changes/hour
- Photoperiod: 12 hrs dark / 12 hrs light


IN-LIFE DATES: From: 20th January 2010 To: 29th January 2010
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated left eye served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): N/A


VEHICLE
N/A
Duration of treatment / exposure:
Single dose. Eyes held shut for at least 1 second.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed
- Time after start of exposure: N/A


SCORING SYSTEM: See any other information section.


TOOL USED TO ASSESS SCORE: NDA
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
At 1, 24, 48 and 72 hr after treatment, no signs of irritation were observed in the rabbits.
Other effects:
None reported.

Table 1. Individual scores.

Time after exposure Animal number Corneal effects Iris Conjuctivae Discharge
Score Area Redness Swelling
1 2 0 4 0 0 0 0
4 0 4 0 0 0 0
6 0 4 0 0 0 0
24 2 0 4 0 0 0 0
4 0 4 0 0 0 0
6 0 4 0 0 0 0
48 2 0 4 0 0 0 0
4 0 4 0 0 0 0
6 0 4 0 0 0 0
72 2 0 4 0 0 0 0
4 0 4 0 0 0 0
6 0 4 0 0 0 0
Interpretation of results:
other: not classified according to EU criteria
Conclusions:
At 1, 24, 48 and 72 hr after treatment, no signs of irritation were observed in the rabbits.
Executive summary:

The eyes of 3 young New Zealand White rabbits were assessed for irritation by application of Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) according to OECD 405. The study was conducted to GLP standard.

At 1, 24, 48 and 72 hr after treatment, no signs of irritation were observed in the rabbits.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

SKIN

Hagermann (1992) (% composition of substance in test material: 70:30), K1

The Hagemann, in vivo skin irritation study was performed according to the OECD guideline for testing No. 404, and was conducted under conditions of Good laboratory practice. Under the conditions of the test 0.5 mL of the test material was applied unchanged to a gauze patch (12 x 16 cm2) and applied to the shaved, right flank of 3 female albino rabbits. The patches were removed after 4 hours and the animals were observed for skin reactions at 1, 24, 48 and 72 hours after removal of the gauze patches. The scoring system used was that shown in the OECD guideline. Erythema was noted in all animals and was scored at 2 for each animal (mean of 24 -48 -72 hours). Erythema persisted in all animals at the 2 level for 72 hours, and then at a level of 1 (with scaling also noted) for 7 days post removal of the patch, because of this the observation period was extended to 10 days at the end of which all irritation was reversed. Oedema was noted in all animals and was scored at 1 for each animal (mean of 24 -48 -72 hours), these effects were fully reversible in 72 hours.

EYES

- In vitro

Prinsen (2009) (% composition of substance in test material: 97.9%), K1

Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) was evaluated neat in the Isolated Chicken Eye (ICE) test, according to OECD guideline no. 438. Chicken eyes were obtained from slaughter animals used for human consumption. The isolated chicken eyes were exposed to a single application of the test sample for 10 seconds using an application volume of 30 µL. Benzalkonium chloride (BAC) 5% was used as the positive control and physiological saline as the negative control. Three main parameters were measured to disclose possible adverse eye effects: corneal thickness (expressed as corneal swelling), corneal opacity and fluorescein retention of damaged epithelial cells.

The negative control eye showed no corneal effects. The positive control caused moderate swelling, severe opacity and severe fluorescein retention. The calculated Irritation Index was 149. Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) caused very slight swelling, very slight opacity and very slight fluorescein retention. The calculated Irritation Index was 22.

On the basis of the results obtained in the ICE test and according to its classification schemes, Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) was considered not irritating to eyes.

- In vivo

Prinsen (2010) (% composition of substance in test material: 97.9%), K1

The Prinsen, 2010 in vivo eye irritation study was conducted according to OECD guideline 405 and under conditions of Good Laboratory Practice. 0.1ml of the unchanged registered substance was instilled in the conjunctival sac of the right eye of 3 SPF bred New Zealand White albino rabbits. Observations were made at 1, 24, 48 and 72 hours after treatment. No irritation was noted at any of the observation periods.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to skin or eye irritation.