Registration Dossier

Administrative data

Description of key information

Eye irritation: 
1) In a primary eye irritation study performed according to OECD Guideline 405, performed under GLP conditions in 1996. Based on the score of 1 in the Cornea opacity and the reversibility of all the effects the test substance would be classified as H319 Causes serious eye irritation (eye irritant category 2) following CLP regulation (Regulation (EC) No 1907/2006).
2) In vivo study performed following the guideline described by the US Pharmaceutical Manufacturers Association 1977, under GLP conditions in 1986. From the results of this study, according to the Kay and Calandra scheme the test substance can be classified as moderately irritant for the unwashed eyes and mildly irritating for remedially irrigated eyes. According to the GHS system and the CLP regulation scheme, based on the grading of ocular lesions as described in OECD 405 guideline, the tested substance should not be classified for eye irritancy.
3) In-vitro-study using the guideline HET-CAM, performed under GLP conditions in 1996. In this reliable and conclusive study, the test substance is considered as slightly irritant.
Skin irritation:
In a primary skin irritation test performed in 1996, following OECD guideline 404 and under GLP conditions, the test item showed irritant potential to the skin. Based on results obtained and specifically on the scores in erythrema, the substance is classified as skin irritant category 2 (H315) following the criteria set out in CLP regulation and GHS system. According to the Dangerous Substances Directive (67/548/EEC): the substance is classified as irritating to skin (R38)

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:
from 20th of May to 12th of June, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: SPF Albino Rabbits
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
after 4 h of exposure, the tape and patches were removed and the treated skin was cleaned with lukewarm water.
Observation period:
The skin reactions were read 1 h after the patches removal. reading was also made 24, 48 and 72 h after termination of exposure. Also 7, 14 and 21 days after
Number of animals:
3
Irritation parameter:
erythema score
Remarks:
Erythema-Eschar
Basis:
animal #1
Time point:
other: 1h after patch removal
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Remarks:
Erythema-Eschar
Basis:
animal #2
Time point:
other: 1h after patch removal
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Remarks:
Erythema-Eschar
Basis:
animal #3
Time point:
other: 1h after patch removal
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Remarks:
Erythema-Eschar
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Remarks:
Erythema-Eschar
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Remarks:
Erythema-Eschar
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1h after patch removal
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1h after patch removal
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1h after patch removal
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 21 days
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
In view of the results obtained, the test item is considered to be irritant , based on the criteria set out in directive 2001/59/EC, Annex VI, and it is therefore assigned the risk phrase R38. According to CLP Regulation (EC No 1272/2008) and the Globally Harmonized System of Classification and Labeling of Chemicals /GHS) the test item has to be classified as Category 2 (irritant) and assigned the risk phrase H315 .
Executive summary:

The test substance SAT 960 266 (CAS number 28219 -60 -5) was assessed on its skin irritation potential according to test method described in the OECD Guidelines nº 404 (1992) and EEC Guideline B.4 (1992).

As a results, after 24 hours in all rabbits a moderate erythema and a slight oedema was seen, and after 48 and 72 h, a moderate to severe erythema and a moderate oedema was observed in all the rabbits.

On day 7 all test areas of all animaks were covered with scales. Animal No 824 showed a slight swelling of test areas. 

On day 14 test areas of animal No. 824 were completely covered with scales, those of animal No. 822 were covered at 80%. Left test area of animal No. 803 was covered at 75%, right test area was covered at 30%.

On day 21, none of the animals showed skin reactions

The mean individual erythema scores were 2,67 for all three animals

The mean individual oedema scores were 1,67 for all three animals

The conclusion is that the test item is considered to be irritant based on the criteria set out in DSD/DPD regulation and it is therefore assigned the risk phrase R38. According to CLP regulation and the GHS criteria the test item has to be classified as Category 2 (irritant) and assigned the risk phrase H315.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
from 30/4/1996 to 15/7/1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
february 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
29th December, 1992
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: SPF Albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Russian from Mollegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved
- Age at study initiation: no data
- Weight at study initiation: 2.0-2.1 Kg
- Housing: caged individually in PPO cages (3224 cm2) with perforated floor
- Diet (e.g. ad libitum): pelleted complete rabbit diet available ad libitum
- Water (e.g. ad libitum): free access to domestic drinking water acidified with hydrochloric acid to pH 2.5
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20ºC±3
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10times/hour
- Photoperiod (hrs dark / hrs light): 12h light/12 h dark
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Observation period (in vivo):
1h, 24h, 48, 72h, 7 days and 14 days
Number of animals or in vitro replicates:
3 females SPF Albino Rabbits
Details on study design:
Testing Procedure:
the test article was placed in the eye of the rabbits by gently pulling the lower lid away from the eyeball to form a cup into which the article was dropped. The lids were then gently held together for 1 second
After the 24h reading, Fluorescein was instilled. After, rinsing with 20mL 0.9% NaCl was applied

SCORING SYSTEM: see attachment

TOOL USED TO ASSESS SCORE: Fluorescein
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 days
Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The test item should be classified as eye irritating category 2 based on the criteria of CLP Regulation (EC) No. 1272/2008
Executive summary:

The eye irritant effect of the test item was investigated according to the method OECD guideline Nº 405, version Feb 1987.

Three female albino rabbits were exposed to 0.1 mL of the test substance in the left eye. The eyes were examinated and the schanges graded according to a numerical scale 1, 24, 48 and 72h as well as 7 days and in 1 animal 14 days after dosing.

Moderate signs of irritation were observed among the rabbits. All effects were reversible after 7 days except in one animal for which a slight redness of conjunctivae only was observed. This effect dissappeared at the 14 day observation.

According to the criteria as set in directive of the EEC commission 93/21/EEC of April 21 (1993) the test item shall not be classified as eye irritating. Based on the criteria of CLP Regulation (EC) No. 1272/2008 it should be classified as eye irritant category 2.

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1996-04-10 to 1996-04-22
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
this study was conducted under GLP. According to ECHA Endpoint Specific Guidance Chapter R.7a (2012, page 183), " Positive outcome from four in vitro assays, the BCOP, ICE, IRE and HET-CAM are accepted by the EU to classify severe eye irritants under Annex VII and Annex VIII using the adaptations of the standard testing regime specified in Annex XI. They have undergone a formal retrospective evaluation, and their scientific validity has been the subject of a statement by ESAC (2007). For the lower ranges of irritancy no assay is currently accepted by regulators."
Qualifier:
no guideline available
Principles of method if other than guideline:
According to ECVAM Test Method Submissions 2008-2014, the Eye irritation Chorioallantoic membrane vascular assay (TM2008-06) is under external validation (status: February 2014). The study follows HET-CAM Test INVITTOX n° 47 (ECVAM DB-ALM., 1992, p. 1-8).
GLP compliance:
yes
Species:
other: hen eggs
Strain:
other: White Leghorn (Shaver-Starcross 288)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: eggs from Horst poultry breeding, Leverkusen, Germany
- Age at study initiation: not applicable, since eggs were used
- Weight at study initiation: not applicable, since eggs were used
- Housing: not applicable, since eggs were used
- Diet (e.g. ad libitum): not applicable, since eggs were used
- Water (e.g. ad libitum): not applicable, since eggs were used
- Acclimation period: not applicable, since eggs were used

ENVIRONMENTAL CONDITIONS
- Temperature: 37.6 °C (± 1.0 °C) in climate cabinet (Ehret, type KMB 4)
- Humidity: 40-60 % in climate cabinet (Ehret, type KMB 4)
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

IN-LIFE DATES: 1996-04-10
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
exposure up to 87 seconds
Observation period (in vivo):
after exposure of up to 87 seconds determination of hemorrhagy, coagulation and lysis on the corion allantoic membrane (CAM)
Number of animals or in vitro replicates:
two eggs in the pretest
six eggs in the main test
Details on study design:
REMOVAL OF TEST SUBSTANCE: not applicable

SCORING SYSTEM:
Calculation of the stimulus potential Q:

1) Yki = (301 - Xki) / Xki
Y: time duration
k: type of reaction (hemorrhagy, coaggulation, lysis)
i: number of egg
X: time at which the type of reaction was observed at the first time

2) weighing factor g1k
g1k = ( 301 - 1/M * Sum(Xki) ) / 10

3) dki = 1 if Xki is unequal to 301
dki = 0, if Xki = 301

4) weighing factor g2k
g2k = 301 - 1/M * Sum(dki)

5) for one reaction type: Rki = g1k * Yki g2k

6) for three reaction types: Si = Sum(Rkj)

7) relative stimulus reaction Q = stimulus reaction of test substance / stimulus reaction of reference substance

TOOL USED TO ASSESS SCORE: illumination ba a lamp
Irritation parameter:
in vitro irritation score
Remarks:
Stimulation index
Run / experiment:
stimulation index of test item
Value:
171.2
Irritation parameter:
in vitro irritation score
Run / experiment:
stimulation index of reference substance
Value:
600.4
Irritation parameter:
in vitro irritation score
Remarks:
Q = stimulation index of test substance / stimulation inedx of reference substance
Run / experiment:
Q = stimulation index of test substance / stimulation inedx of reference substance
Value:
0.29

Table 1 Results of the reaction time method

 Substance  type of reaction  start (sec) = X  Stimulation index     Q
 hemorrhagy  22      
reference substance Texapon ASV (5 %)  lysis  30  mean  600.4  1.00
   coagulation  -  s.d.  67.5  
   hemorrhagy  53      
test substance Sandelice (> 85 %)  lysis  87  mean  171.2  0.29
   coagulation  -  s.d.  28.5  

s.d.: standard deviation

Q = stimulation index of test substance / stimulation inedx of reference substance

Interpretation of results:
GHS criteria not met
Conclusions:
In a reliable and conclusive study, the test substance is considered as slightly irritant only due to the results of the HET-CAM study and the comparison with the stimulation potential of the reference substance. Based on the long-term experiences on the comparibility of these in vitro results with in vivo results, the test substance is considered to be not irritating to mucosa membranes or eyes in a Draize test.
Executive summary:

The potential of the test substance for irritating the chorion allantois membrane (CAM) of fertilized and incubated hen eggs was determined in the in vitro HET-CAM test.

The relative stimulation potential of the test substance (> 85 %, undissolved) and the reference substance Texapon ASV (5%) was determined by using the reaction time method. The reference substance in the selected test concentration is assessed as moderately irritating in the Draize test on the rabbit eye.

The stimulation potental Q of the undissolved test substance Sandalice - S 544 (> 85 %) is smaller (Q=0.29) than the reference substance Texapon ASV (Q=1.00).

For the assessment of in vitro results the following values of the relative stimulation potential are defined:

Q </= 0.8 (slightly irritating)

0.8 < Q < 1.2 (moderatly irritating)

1.0 </= Q < 2.0 (irritating)

Q >/= 2.0 (strongly irritating)

Regarding the results, the test substance (> 85 %) is assessed as less irritating than Texapon ASV (5 %). Based on the long-term experiences on the comparibility of these in vitro results with in vivo results, the test substance is considered to be not irritating to mucosa membranes or eyes (Draize test).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 25/6/1986 to 4/8/1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
other: US Pharmaceutical Manufacturers Association 1977
Deviations:
yes
Remarks:
1) The observation on day 0 of the study was not performed 60 min after installation of the test substance as protocoled, but after approximately 80 min. 2) In the night of study day 13 and 14 the temperature in the animal room raised up to 28°C.
Qualifier:
according to
Guideline:
other: US EPA Pesticide Assessment Guidelines, Subdivision F $81-4 “Primary Eye Irritation”
Version / remarks:
version: Nov. 1984. EPA protocol in accordance with the FDA requirements.
Deviations:
yes
Remarks:
with the following exception: Three additional animals have been used to investigate the effect of remedial irrigation
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands
- Age at study initiation: 2 to 3 months old
- Weight at study initiation: 1.9 to 2.4 grams
- Housing: individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): standard laboratory animal diet. 100g/day
- Water (e.g. ad libitum): tap water free access
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-21 ºC
- Humidity (%): 60-85%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h light/12h dark
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
24 hours for animals #1 to #6 (marked as no remedial irrigation applied) and 30 seconds for animals #7 to #9 (marked as remedial irrigation applied)
Observation period (in vivo):
Immediately after instillation of the test substance
70-90min after instillation
24,48 and 72h after instillation
7 and 14 days after instillation
Number of animals or in vitro replicates:
9 young adult female animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after application, the lids were held gently together for 2 seconds and released. The treated eye was washed with 125-150 mL tepid tap-water for aprox 1 minute
- Time after start of exposure: 30 seconds

SCORING SYSTEM: The Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

FLUORESCEIN TREATMENT: Fluorescein was used to determine the area of corneal epitheliak damage, For that purpose, a solution of 2% sodium fluorecein in water (pH adjusted to 7) was applied to both eyes.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
mean individual scores of the unwashed eyes after application (animals #1 to #6)
Time point:
24/48/72 h
Score:
0.44
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
mean individual scores of the washed eyes after application (animals #7 to #9)
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 0 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
mean individual scores of the unwashed eyes after application (animals #1 to #6)
Time point:
24/48/72 h
Score:
0.18
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
mean individual scores of the washed eyes after application (animals #7 to #9)
Time point:
24/48/72 h
Score:
0.22
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
mean individual scores of the unwashed eyes after application (animals #1 to #6)
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
mean individual scores of the washed eyes after application (animals #7 to #9)
Time point:
24/48/72 h
Score:
1.11
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
mean individual scores of the unwashed eyes after application (animals #1 to #6)
Time point:
24/48/72 h
Score:
0.44
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
mean individual scores of the washed eyes after application (animals #7 to #9)
Time point:
24/48/72 h
Score:
0.44
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Remarks:
mean individual scores of the unwashed eyes after application (animals #1 to #6)
Time point:
24/48/72 h
Score:
0.5
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Remarks:
mean individual scores of the washed eyes after application (animals #7 to #9)
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 7 days
Interpretation of results:
GHS criteria not met
Conclusions:
According to the GHS and CLP criteria for classification of the eye irritancy potential, based on the grading of ocular lesions as described in OECD 405 guideline, the tested substance should not be classified for eye irritancy under the test conditions
Executive summary:

A sample of the test item was tested in the rabbit acute eye irritation/corrosion test to determine its possible irritating or corrosive effects. Approximately 0.1 mL of the test substance was instilled into one of the eyes of nine female albino rabbits, three of which subsequently received remedial irrigation. The unwashed eyes reacted to contact with the test substance by corneal damage, involving the epithelium and in some cases also the stroma, slight iridial irritation and moderate conjunctival reddening and swelling. Remedial irrigation appeared to have a positive effect on the degree of corneal injury but it hardly reduced the irritation of conjunctivae and iris. From these results a Draize score of 19.8 was obtained for unwashed eyes and 10 for remedially irrigated eyes (both at 24 hours). According to the Kay and Calandra scheme the test substance can be classified as moderately and mildly irritating, respectively. However according to the GHS (Globally Harmonized System of Classification and Labeling of Chemicals) and CLP regulation (Regulation (EC) No 1907/2006) scheme for classification of the eye irritancy potential, based on the grading of ocular lesions as described in OECD 405 guideline, the tested substance should not be classified for eye irritancy under the test conditions.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

On eye irritation endpoint, three studies are available and considered together in a weight of evidence approach:

 

1)     In a primary eye irritation study according to OECD Guideline 405 (Acute Eye Irritation / Corrosion) under GLP conditions in 1996, the test substance shows a slight eye irritancy potential for cornea opacity. This result is just on the threshold which triggers the eye irritation classification of H319 Eye Irritant category 2 and therefore the substance is classified accordingly. All effects were reversible after 7 days except in one animal for which a slight redness of conjunctivae only was observed. This effect disappeared at the 14 day observation and was considered not relevant for classification in view of the other results of the other two available tests.

 

2)     In another test performed in 1986 according to the guideline as stated in the US Pharmaceutical Manufacturers Association 1977 under GLP conditions, the test substance showed a slight irritancy potential, but below the threshold of classification.

 

3)     Finally, in an In-vitro HET-CAM test performed in 1996, under GLP conditions, and conducted with the same batch as in the OECD 405 test, the substance showed a slightly irritant potential based on the comparison with a reference substance. According to the study director judgement, based on the long-term experiences on the comparibility of these in vitro results with in vivo results, the test substance is considered to be not irritating to mucosa membranes or eyes (Draize test).

 

Considering the results in a weight of evidence approach of the three reliable and conclusive tests, it was considered that the worst case scenario should be used for classification, based on the OECD 405 study. The substance is therefore classified as eye irritation classification of H319 Eye Irritant category 2.

 

On skin irritation one study is available:

In a primary skin irritation test performed in 1996 following OECD guideline 404 and under GLP conditions, the test item showed irritancy potential. Based on the results obtained and specifically on the scores obtained in erythrema the substance is classified as skin irritant category 2 (H315) based on the criteria set out in CLP regulation. According to the Dangerous Substances Directive (67/548/EEC): the substance is classified as irritating to skin (R38).


Justification for classification or non-classification

Eye Irritation:

Considering the results in a weight of evidence approach of the three reliable and conclusive tests, it was considered that the worst case scenario should be used for classification, based on the OECD 405 study. The substance is therefore classified as eye irritation classification of H319 Eye Irritant category 2.

Skin Irritation:

Based on the results obtained and specifically on the scores obtained in erythrema the substance is classified as skin irritant category 2 (H315) based on the criteria set out in CLP regulation.