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Diss Factsheets

Administrative data

Description of key information

Skin irritation: not irritating
Eye irritation: not irritating

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:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
They study was performed in accordance with generally accepted scientific principles and presented as a short abstract. There was adequate reporting of the methodology and results. Based on the available information the study can be considered reliable, but with restrictions.
Qualifier:
no guideline followed
Principles of method if other than guideline:
The irritation potential of the undiluted test material was determined using 3 rabbits (2 male and 1 female). The clipped intact skin of each rabbit was exposed to the test material under an occlusive dressing for 24 hours. Animals were observed for signs of irritation for 7 days and scored in accordance with the Draize scale (1944).
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
-Sex: Male and female
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- The test material was applied undiluted.
Duration of treatment / exposure:
24 hours.
Observation period:
7 days
Number of animals:
2 males and 1 female
Details on study design:
TEST SITE
- Preparation of exposure area: The skin of each animal was clipped and left intact.
- Type of wrap if used: The treated area was covered with plastic strips.

REMOVAL OF TEST SUBSTANCE
- The patch ws removed after 24 hours.

SCORING SYSTEM: Draize scale (1944).
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 3 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 5 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No skin changes were noted after the first hour. Erythema ranging from barely perceptible to well-defined where one instance of slight edema developed in 24 hours, giving an average score of 2.0.
Following removal of the application, effects were reversible within 3 days in one animal and by day 5 in all others.

Table 1: Results

Animal No. and Sex

Irritation Score for Erythema and Edema, Hours After Removal

1 Hour

24 Hours

48 Hours

72 Hours

120 Hours

168 Hours

1- Male

0

2

2

1

0

0

2- Female

0

1

1

0

0

0

3- Male

0

3

2

1

0

0

Average

0.0

2.0

1.6

0.6

0.0

0.0

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, slight to mild irritation was observed 24 hours after removal of the undiluted test material. This reaction was reversible in one animal after 3 days and after 5 days in the remaining two animals. The author of the report concludes that the test material is a slight to mild irritant, however the recorded irritation was not sufficient for classification in accordance with CLP; the test material is therefore determined to be not irritating.
Executive summary:

The irritation potential of the undiluted test material was determined using 3 rabbits (2 male and 1 female). No guideline was followed. The clipped intact skin of each rabbit was exposed to the test material under an occlusive dressing for 24 hours. Animals were observed for signs of irritation for 7 days and scored in accordance with the Draize scale (1944).

Under the conditions of the test, slight to mild irritation was observed 24 hours after removal of the undiluted test material. This reaction was reversible in one animal after 3 days and after 5 days in the remaining two animals. The author of the report concludes that the test material is a slight to mild irritant, however, the recorded irritation was not sufficient for classification in accordance with CLP; the test material is therefore determined 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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This GLP Study was conducted equivalent or similar to OECD 405 protocol.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harvey's Lake, PA, US
- Weight at study initiation: 1955 - 2198 g
- Housing: Single caged
- Diet: ad libitum)
- Water: ad libitum
- Acclimation period: five (5) days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): within OECD guidelines
- Humidity (%): within OECD guidelines
- Photoperiod (hrs dark / hrs light): within OECD guidelines

IN-LIFE DATES: From: 10 March 1986 To: 13 March 1986
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL/eye 100%
Duration of treatment / exposure:
72 hrs
Observation period (in vivo):
72 hrs
Number of animals or in vitro replicates:
6 (3 males, 3 females)
Details on study design:
SCORING SYSTEM:
An animal exhibited a positive reaction when the test substance produced one of more of the following signs: ulceration of the cornea (other than a fine stippling), opacity of the cornea (other than a slight dulling of the normal luster), inflammation of the iris (other than a slight deepening of the rugae or a light hyperemia of the circumcorneal blood vessels), or an obvious swelling in the conjunctivae (excluding the cornea and iris) with partial eversion of the eyelids and a diffuse crimson color with individual vessels not easily discernible. Grading of irritation was according to the method of Draize, 1965. The test was considered positive if four or more of the animals in the test group exhibited a positive reaction. If only one animal exhibited a positive reaction, the test would have been regarded as negative. If two or three animals exhibited a positive reaction, the study director in charge of the test may have designated the substance to be an irritant unless the sponsor, at additional cost, suggested repeating the test using a different group of animals.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.66
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
All animals exhibited conjunctival redness that was fully reversible within 72 hr. 4 of 6 animals exhibited chemosis that was fully reversible within 24 hours.
Other effects:
No other effects were observed.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the conditions of this study, the test material is not classified as an eye irritant.
Executive summary:

In an eye irritation study, New Zealand white rabbits were treated with 0.1 ml of test substance into their right eyes. Observations were recorded at 1, 24, 48, and 72 h. Positive ocular scores were recorded at the 1 and 24 hour observation periods. No other positive scores were recorded. Based on the results of this study, the test substance is not classified in accordance with the classification system of GHS. This study is classified as acceptable and satisfies the guideline requirement for eye irritation study in rabbits.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation:

The skin irritation dataset contains two studies performed using the substance to be registered and a further seven studies performed on read across substances.

In the key study, Younger (1966), the irritation potential of the undiluted test material was determined using 3 rabbits (2 male and 1 female). No guideline was followed. The clipped intact skin of each rabbit was exposed to the test material under an occlusive dressing for 24 hours. Animals were observed for signs of irritation for 7 days and scored in accordance with the Draize scale (1944). Under the conditions of the test, slight to mild irritation was observed 24 hours after removal of the undiluted test material. This reaction was reversible in one animal after 3 days and after 5 days in the remaining two animals. The author of the report concludes that the test material is a slight to mild irritant, however, the recorded irritation was not sufficient for classification in accordance with CLP; the test material is therefore determined to be not irritating.

A further supporting study was performed on the substance to be registered (at a purity of 80 %), Rush (1991). In the primary dermal irritation study, 6 young adult New Zealand white rabbits were dermally exposed to 0.5 mL of the test material for 24 hours.  Animals then were observed for 72 hours and the study was terminated before full reversibility could be determined. Irritation was scored by the method of Draize. Under the conditions of the test, the test substance was not a dermal irritant.

The remaining seven supporting studies were performed using two read across substances. All read-across studies demonstrate that these categories of substances are not dermal irritants.

Eye Irritation:

The eye irritation dataset contains three studies performed using the substance to be registered and seven performed on read across substances.

In the key study, Mallory (1986), the irritation potential of the substance to be registered was determined in an acute eye irritation study performed under GLP conditions and followed a protocol similar to that of OECD 405. The test material was instilled into the right eye of 6 New Zealand white rabbits (3 male and 3 female). The eye was examined at 1, 24, 48, 72 hours after administration and scored for ocular irritation in accordance with the Draize scale (1965). Due to the absence of irritation at 72 hours the study was terminated. Under the conditions of the test, animals displayed mild discomfort immediately following application of the test material. One hour after application there was moderate discharge, mild swelling and redness, and slight iris congestion. Edema and corneal dullness increased by 24 hours. Following irrigation 24 hours post application, congestion reduced so that iris clarity was practically normal by day 5. Based on these results the author of the report concludes that the test material is an eye irritant. However, the observed reactions were mild and not sufficient for classification as an irritant under Regulation (EC) No. 1272/2008.

Two further studies on the material to be registered have been provided as supporting data. The first study, Mallory (1999), was conducted using a 60 % solution in an acute eye irritation study performed under GLP conditions and followed a protocol similar to of OECD 405. Under the conditions of the test, three of the six animals displayed reactions at the 24, 48 and 72 hour time points. The mean scores for corneal opacity, iris, conjunctivae redness and chemosis at these time points was mild. Since the substance was tested in a 60 % solution the results are unreliable and not sufficient for classification in accordance with Regulation (EC) No. 1272/2008. The second study, Younger (1996), was performed in accordance with generally accepted scientific principles, but was presented as an abstract and thus the reliability of the data could not be assessed. Under the conditions of the test, animals displayed mild discomfort immediately following application of the test material. One hour after application there was moderate discharge, mild swelling and redness, and slight iris congestion. Edema and corneal dullness increased by 24 hours. Following irrigation 24 hours post application, congestion reduced so that iris clarity was practically normal by day 5. Based on these results the author of the report concludes that the test material is a mild eye irritant. The results are insufficient to determine a classification in accordance with Regulation (EC) No. 1272/2008.

Data from the studies conducted using the substance to be registered have demonstrated that the test material does not elicit eye irritation at a level that requires classification.

 

Five further supporting studies have been provided on read-across substances.

The results from the three studies conducted using the substance to be registered clearly demonstrated that the test material is not an eye irritant sufficient for classification in accordance with Regulation (EC) No. 1272/2008.


Justification for selection of skin irritation / corrosion endpoint:
The skin irritation dataset contains two studies performed using the substance to be registered and a further seven studies performed on read across substances.
Younger (1966) has been selected as the key study in addressing this endpoint, since the study was performed using the substance to be registered in an undiluted form. The study was performed in accordance with generally accepted scientific principles and presented as a short abstract, with adequate reporting of the methodology and results to allow the reliability of the results to be assessed. Based on the available information, the study can be considered reliable, but with restrictions (Klimisch 2) in accordance with Klimisch et al. (1997).
A further supporting study was performed on the substance to be registered, Rush (1991). This study was conducted to guidelines and GLP; however, the test material was only 80 % pure with the remaining 20 % comprised of a similar calcium sulphonate that is a known skin irritant. The test period was 24 hours instead of 4 hours, representing a worst case scenario. The test ended at 72 hours before full reversibility could be determined.
The remaining seven studies were performed using two read across substances and have been provided as supporting data.

Justification for selection of eye irritation endpoint:
The eye irritation dataset contains three studies performed using the substance to be registered and seven performed on read across substances.
Mallory (1986) has been selected as the key study in addressing this endpoint, since the study was performed using the substance to be registered in an undiluted form. The study was performed in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results. The study was assigned a reliability score of 2 (reliable with restrictions) in accordance with Klimisch et al. (1997).
Two further supporting studies were performed on the substance to be registered. The first study, Mallory (1999), was conducted using a 60 % solution and is thus not suitable for classification. The study was assigned a reliability score of 3 (not reliable) in accordance with Klimisch et al. (1997). The second supporting study by Younger (1996), was performed in accordance with generally accepted scientific principles, but was presented as an abstract and thus the reliability of the data could not be assessed. The study was therefore assigned a reliability score of 4 (not assignable) in accordance with Klimisch et al. (1997).
The remaining five studies were performed using two read across substances and have been provided as supporting data.

Justification for classification or non-classification

Skin Irritation:

According to the criteria outlined in Regulation (EC) No. 1272/2008, the test material does not meet the criteria for classification as a skin irritant.

Eye Irritation:

According to the criteria outlined in Regulation (EC) No. 1272/2008, the test material does not meet the criteria for classification as an eye irritant.