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Diss Factsheets

Administrative data

Description of key information

Skin irritation: 
1.) in vitro: Under the conditions of the test, the results indicate that the test article, both at 100% and at 10%, has expected in vivo dermal irritancy potentials in the non-irritating range. 2.) In vivo: Primary Irritation Index: 0.08. The test material is not a primary dermal irritant to rabbits under the conditions of this test. 3.) The test item is considered to be slightly irritating after repeated dermal exposure.
Eye irritation:
1.) In vitro: Under the conditions of the test, the results indicate that the test article at both percentages tested (20% and 2%), has a non-irritating classification. 2.) In vivo: The test material is not an ocular irritant to rabbits under the conditions of the test.

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:
13 Oct. 1978 - 31 Okt. 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
: 24 hours exposure period
Principles of method if other than guideline:
The test method was essentially that of Draize et al:
Draize, John H., Woodward, Geoffrey, and Calvery, Herbert O., "Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes", J. Pharm. & Ex. Ther. 82, 377, (1944).
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Summit View Farm, Belvidere, New Jersey, USA
- Diet: Wayne animal feed, ad libitum
- Water: ad libitum
- Acclimation period: conditioned prior to use
Type of coverage:
occlusive
Preparation of test site:
other: clipped areas of intact and abraded skin
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
24 hours (The wrapping and test material were removed 24 hours following application)
Observation period:
24 and 72 hours following application
Number of animals:
6 (mixed sex)
Details on study design:
TEST SITE
- Area of exposure: trunk, test material application under 2" x " gauze
- Type of wrap if used: (2" x " gauze, covered by adhesive tape) and the entire trunk of each animal was covered with an impermeable occlusive wrapping

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours following application

SCORING SYSTEM: according to Draize scale (erythema formation 0-4, edema formation 0-4, total possible primary irritation score = 8)
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal: 1 to 6
Time point:
other: 24 h and 72 h
Score:
0.08
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal: 1 to 6
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: 1 to 6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Primary Irritation Index: 0.08
The test material is not a primary dermal irritant to rabbits under the conditions of this test.

Summary of Scores for Skin Irritation: 

Rabbit

Hours:

24

72

Number

Skin

E1

Ed

E

Ed

1

NA2

A3

0

0

0

0

0

0

0

0

2

NA

A

0

1

0

0

0

0

0

0

3

NA

A

0

0

0

0

0

0

0

0

4

NA

A

0

1

0

0

0

0

0

0

5

NA

A

0

0

0

0

0

0

0

0

6

NA

A

0

0

0

0

0

0

0

0

Average

NA

A

0.0

0.3

0.0

0.0

0.0

0.0

0.0

0.0

Combined Averages:     0.3

Primary Irritation Index:   0.08  

1E/Ed = Erythema and Edema

2NA   = Non-abraded skin

3A     = Abraded skin

Interpretation of results:
GHS criteria not met
Conclusions:
Primary Irritation Index: 0.08
The test material is not a primary dermal irritant to rabbits under the conditions of this test.
Executive summary:

Six albino New Zealand rabbits, mixed sex, were used in a Primary Dermal Irritation study according to the method of Draize et al.

0.5 ml of the test material, as received, was applied to clipped areas of intact and abraded skin. Applications were made under occlusive patches. The wrapping and test material were removed 24 hours following application. The sites were individually examined and scored separately for erythema and edema at 24 and 72 hours. The mean scores for 24 and 72 hour gradings were averaged to determine final irritation indices.

As the result the Primary Irritation Index was 0.08. Under the conditions of the test the test material is not a primary dermal irritant.

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 February 1998 - 26 February 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes
Amount / concentration applied:
100 µl of test article 100% and 10% were applied to the Millicells containing the EpiDerm samples.
Irritation / corrosion parameter:
other: other: ET50
Value:
> 24
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other:
Remarks:
Basis: other: average % viability. (migrated information)
Other effects / acceptance of results:
The test article , at both 100% and at 10%, elicted ET-50's greater than 24 hours

 

Article

Conc.

(%)

Replicate Testing

n=

Exposure (hours)

Average

Viability

(%)

ET50

Classification

Finsolv TN

100

3

18

97

 

 

Finsolv TN

100

3

4

110

 

 

Finsolv TN

100

3

2

119

>24 hrs

Non-irritating

Finsolv TN

10

2

18

90

 

 

Finsolv TN

10

2

4

103

 

 

Finsolv TN

10

2

2

117

>24 hrs

Non-irritating

Corn oil

(neg. control)

100

6

4

100

N/A

N/A

Triton X-100

1

2

18

11

 

 

Triton X-100

1

2

4

76

 

 

Triton X-100

1

2

2

74

6 hrs

Moderate to mild

 

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test, the results indicate that the test article, both at 100% and at 10%, has expected in vivo dermal irritancy potentials in the non-irritating range.
Executive summary:

Substance was tested for irritancy potential utilising the MatTek Corporation EpiDerm in an In Vitro Skin Irritation study on Reconstructed Human Epidermis.

The test article tested at both 100% and at 10%, elicted ET-50's greater than 24 hours. Under the conditions of the study, the test article FINSOLV TN was non-irritating and has expected in vivo dermal irritancy potentials in the non-irritating range.

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
Study period:
13 October 1978 to 31 October 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Summit View Farm, Belvidere, New Jersey, USA
- Diet: Wayne animal feed, ad libitum
- Water: ad libitum
- Acclimation period: conditioned prior to use
Vehicle:
unchanged (no vehicle)
Controls:
other: left eye, remaining untreated, of each rabbit served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 ml, singe administration
- Concentration (if solution): undiluted, test material as received
Duration of treatment / exposure:
24 h ( no wash)
Observation period (in vivo):
1, 2, and 3 days after treatment, and up to 7 days when necessary
Number of animals or in vitro replicates:
6 (mixed sex), 1.8 - 2.4 kg
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The trated eyes remained unwashed for 24 hours


SCORING SYSTEM: Draize standard scoring system:
Cornea Opacity (A) Grading 0-4
Area of Cornea Involved (B) Grading 0-4
Score equals A x B x 5 Total maximum = 80

Iris Values (A) Grading 0-2
Score equals A x 5 Total maximum = 10

Conjunctivae Redness (A) Grading 0-3
Chemosis (B) Grading 0-4
Discharge (C) Grading 0-3
Score equals (A + B + C) x 2 Total maximum = 20

Note: The maximum total score is the sum of all scores obtained for the cornea, iris and conjunctivae.

TOOL USED TO ASSESS SCORE: hand-held lenses
Irritation parameter:
overall irritation score
Basis:
animal: 1 to 6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: 1 to 6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: 1 to 6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 1 to 6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: 1 to 6
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Result: Draize Score
______________Day_________________
Group 1 2 3 4---------7
_______________________________________________
No Wash 0.0 0.0 0.0 --- ---

The test substance is not an ocular irritant to rabbits under the conditions of the test.

   

Rabbit Number

Day

Cornea:

A x B x 5 +

Iris:

A x 5 +

Conjunctivae: (A+B+C) x 2=

Total Scores*

1, 2, 3, 4, 5, 6

1

0   0

0

 0  0  0

0

1, 2, 3, 4, 5, 6  

2

0   0

0

 0  0  0

0

1, 2, 3, 4, 5, 6

3

0   0

0

 0  0  0

0

1, 2, 3, 4, 5, 6

4

-   -

-

 -  -  -

-

1, 2, 3, 4, 5, 6

7

-   -

-

 -  -  -

-

Average

1

 

 

 

0.0

 

2

 

 

 

0.0

 

3

 

 

 

0.0

 

4

 

 

 

-

 

7

 

 

 

-

* Total score possible/animal/observation interval = 110

Interpretation of results:
GHS criteria not met
Conclusions:
The test material is not an ocular irritant to rabbits under the conditions of the test.
Executive summary:

The test substance was tested in an eye irritation study. Six New Zealand rabbits, mixed sex, 1.8 - 2.4 kg, received 0.1 ml test substance (material used as received) in a single administration instilled in the right eye; the left eye, remaining untreated, served as control. The treated eyes of all rabbits remained unwashed for 24 hours. Observations of injuries on the cornea, iris and the bulbar and palpebral conjunctivae were made 1, 2, and 3 days after treatment; further readings were not necessary. Numerical scores were assigned according to the Draize standard scoring system.

Result:                                           Draize Score

_________Day____________

Group 1 2 3 4-------7

No Wash 0.0 0.0 0.0 -- --

The test substance is not an ocular irritant to rabbits under the conditions of the performed test.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion: Benzoic acid, C12-15-alkyl esters was tested for its irritation potential in vitro and in vivo. According to the in vitro and appropriate in vivo study, the test item can be classified as non-irritating. In a repeated dose study for 14 days, no gross changes were observed.

In vitro: Substance was tested for irritancy potential utilising the MatTek Corporation EpiDerm in an In Vitro Skin Irritation study on Reconstructed Human Epidermis. The test article tested at both 100% and at 10%, elicted ET-50's greater than 24 hours. Under the conditions of the study, the test article was non-irritating and has expected in vivo dermal irritancy potentials in the non-irritating range.

In vivo: 1.) Six albino New Zealand rabbits, mixed sex, were used in a Primary Dermal Irritation study according to the method of Draize et al.. 0.5 ml of the test material, as received, was applied to clipped areas of intact and abraded skin. Applications were made under occlusive patches. The wrapping and test material were removed 24 hours following application. The sites were individually examined and scored separately for erythema and edema at 24 and 72 hours. The mean scores for 24 and 72 hour gradings were averaged to determine final irritation indices. As the result the Primary Irritation Index was 0.08. Under the conditions of the test the test material is not a primary dermal irritant.

2.) Repeated dose in vivo study: The study was performed to determine the cumulative dermal effects of the test article on rabbit skin.

Ten New Zealand white rabbits each received daily applications of 0.5 mL test article, at two concentrations and isopropyl myristate and mineral oil as controls, on four test sites, all intact. The applications were carried out for 14 consecutive days. The test sites were scored according to the Draize scale individually for erythema, edema and other effects prior to each application and approximately 24 hours after the last application. Mean combined erythema and edema scores were determined per test and control article, per animal, per day. The test article was used as received and as a 62% gravimetric corn oil suspension.

Result: Average Combined Erythema and Edema Score / Animal / Day:

Test article (neat): 4.64, Test article (62% w/c corn oil): 4.11

Mineral Oil: 2.68, Isopropyl Myristate: 5.40

At all animals no gross changes were observed. Thus, the test item is considered to be slightly irritating after repeated dermal exposure.

Eye irritation / corrosion:

1.) In vitro: Substance was tested for ocular irritancy utilising the MatTek's Corporation in vitro EpiOcular corneal Model. The test article tested at both 20% and at 2%, elicted in vitro results which indicate that its ET-50's are greater than 240 minutes. Therefore the tested article, corresponding at both 100% and 10%, has estimated Draize ocular irritation scores of approximately 0 with a "non-irritating" classification. 2.) In vivo: The test substance was tested in an eye irritation study. Six New Zealand rabbits, mixed sex, 1.8 - 2.4 kg, received 0.1 ml test substance (material used as received) in a single administration instilled in the right eye; the left eye, remaining untreated, served as control. The treated eyes of all rabbits remained unwashed for 24 hours. Observations of injuries on the cornea, iris and the bulbar and palpebral conjunctivae were made 1, 2, and 3 days after treatment; further readings were not necessary. Numerical scores were assigned according to the Draize standard scoring system.

Justification for classification or non-classification

Based on the available data, the substance does not require classification for skin and eye irritaion according to regulation (EC) 1272/2008.