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Diss Factsheets

Administrative data

Description of key information

Skin irritation: Not irritant
Eye Irritation: Not irritant

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:
July 14, 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: "Apparisal of Safety of chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO)
Deviations:
no
GLP compliance:
no
Remarks:
pre GLP
Species:
rabbit
Strain:
other: Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.0 - 2.3 kg
- Housing: individually
- Diet: ad libitum standard rabbit food ( NAFAG Gossau SG)
- Water: ad libitum
- Acclimation period: minimum 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1°C
- Humidity (%): 55 ± 5%
- Photoperiod (hrs dark / hrs light): Cycle light/dark 14 hs
Type of coverage:
occlusive
Preparation of test site:
other: shaved and scarified
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
24 hours exposure
Observation period:
7 days
Number of animals:
3 male and 3 female
Details on study design:
TEST SITE
Gauze patches of 2.5 x 2.5 cm covered with an impermeable material and fastened to the body of the rabbit with adhesive tape
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no erythema
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no erythema
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no erythema
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no erythema
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no erythema
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no erythema
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no edema
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no edema
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no edema
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no edema
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no edema
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no edema
Remarks on result:
no indication of irritation

time 24 h 48 h 72 h 4 d 7 d
sex male female male female male female male female male female
Animal n. 88 90 92 69 71 73 88 90 92 69 71 73 88 90 92 69 71 73 88 90 92 69 71 73 88 90 92 69 71 73
erythema a 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
b 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
oedema a 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
b 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
total a 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
b 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
mean a 0 0 0 0 0 0 0 0 0 0
b 0 0 0 0 0 0 0 0 0 0
group mean a 0 0 0 0 0
b 0 0 0 0 0

a = intact skin

b = abraded skin

Interpretation of results:
other: CLP criteria not met
Conclusions:
Not irritant
Executive summary:

The substance to be registered has been tested on rabbits according to the patch-test technique described in the AFDO Guideline "Apparisal of Safety of chemicals in Foods, Drugs and Cosmetics" (1959). The test substance was applied on intact and abraded skin. No erythema and no oedema were observed during the test.

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:
June 24, 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
Deviations:
no
GLP compliance:
no
Remarks:
pre GLP
Species:
rabbit
Strain:
other: Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.6 - 1.8 kg
- Housing: individually in metal cages (47x32x34 cm)
- Diet: ad libitum standard rabbit food - NAFAG Gossau SG
- Water : ad libitum
- Acclimation period: minimum 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1°C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): Cycle light/dark 14 hs

HEALTH CHECK
- only rabbits with normal ophthalmic finding were used
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
1 minute exposure for 3 rabbits, 8 days exposure for 3 rabbits
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6 rabbits (3 male and 3 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3 rabbits 1 minute after treatment both eyes were rinsed with physiologic saline
- Time after start of exposure: The lids were held open for a few second

SCORING SYSTEM: according to AFDO guideline
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Not irritant

time 1 h 6 h 1 d 2 d 3 d 6 d 8 d
sex m f f m m f m f f m m f m f f m m f m f f m m f m f f m m f m f f m m f m f f m m f
Animal n. 58 63 67 60 62 61 58 63 67 60 62 61 58 63 67 60 62 61 58 63 67 60 62 61 58 63 67 60 62 61 58 63 67 60 62 61 58 63 67 60 62 61
eye, left/right n n n r r r n n n r r r n n n r r r n n n r r r n n n r r r n n n r r r n n n r r r
1. CORNEA                                          
A Opacity 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
B Area involved 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
a = AxBx5 (max 80) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
2. IRIS 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
b = Score x 5 (max 10) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
3. CONJUNCTIVAE                                          
A Redness 1 1 1 1 1 1 1 1 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
B Chemosis 1 1 2 0 1 1 1 1 1 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
C Discharge 1 1 1 0 1 0 1 1 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
    c = (A+B+C)x2 (max 20) 6 6 8 2 6 4 6 6 4 2 6 6 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Total = a+b+c (max 110) 6 6 8 2 6 4 6 6 4 2 6 6 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Group Mean 6.7 4 5.3 4.7 0 0 0 0 0 0 0 0 0 0

According to the CLP Regulation, the mean scores for the substance to be registered, when applied to the eye of the animals, calculated following grading at 24, 48 and 72 hours after instillation of the test material, were 0 for corneal opacity, iritis, conjunctival redness and corneal opacity for all tested animals. 

Interpretation of results:
other: CLP criteria not met
Conclusions:
Not irritant
Executive summary:

The substance to be registered has been tested on rabbits according to the AFDO Guideline "Apparisal of Safety of chemicals in Foods, Drugs and Cosmetics" (1959). The test item has been inserted into the conjunctival sac of the left eye, the right one has been used as a control. In 3 rabbits both eyes were rinsed. A minimal transient conjunctival reaction was observed one hour after the application to the rabbit eye mucosa, this reaction was fully reversible within 24 hours. Rinsing the eyes following instillation was of practically no effect.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The substance was tested during 1977 for skin and eye irritation according to AFDO Guidelines. No irreversible effect was observed during the tests. No erythema or oedema reaction have been observed after skin application; a minimal transient conjunctival reaction observed during eyes test within the 6 hours exposure period, all evaluation parameters were fully reversible during the 24 hours period.

Justification for classification or non-classification

Skin Irritation

According to the CLP Regulation (EC n. 1272/2008), skin corrosion means the production of irreversible damage to the skin, and skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.

A substance has to be classified as Category 1 (Corrosive) if there is the production of irreversible damage to the skin in more than 1 of three animals.

A substance has to be classified as Category 2 (Irritant) if shows:

(1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

(2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or

(3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

 

No Oedema and no Erythema reaction have been observed during the test. The mean values for erythema and for oedema were 0 in all the tested animals therefore the test substance does not need to be classified according to the CLP Regulation.

 

Eye Irritation

According to the CLP Regulation (EC n. 1272/2008), Serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application

Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.

A substance has to be classified as Category 1 (Irreversible effects on the eye), If, when applied to the eye of an animal, a substance produces:

— at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/ or

— at least in 2 of 3 tested animals, a positive response of:

— corneal opacity ≥ 3 and/or

— iritis > 1,5 calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.

A substance has to be classified as Category 2 (irritating to eye) if, when applied to the eye of an animal, a substance produces:

at least in 2 of 3 tested animals, a positive response of:

-         corneal opacity ≥ 1 and/or

-         iritis ≥ 1, and/or

-         conjunctival redness ≥ 2 and/or

-         conjunctival oedema (chemosis) ≥ 2

calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.

 

The mean scores for the test substance calculated following grading at 24, 48 and 72 hours after instillation of the test material to the eye, were 0 for corneal opacity, iritis, conjunctival redness and corneal opacity for all tested animals. 

 

Based on the provided data no classification for eye irritation is warranted under the CLP Regulation.