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Diss Factsheets

Administrative data

Description of key information

Skin irritation - patch test according to AFDO (pre-GLP), rabbit: not irritating;

Eye irritation - study according to AFDO (pre-GLP), rabbit: 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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP non-guideline study, available as unpublished report, predates implementation of GLP and/or development of study guidelines, minor restrictions in design and/or reporting but otherwise adequate for assessment.
Qualifier:
according to guideline
Guideline:
other: patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)
GLP compliance:
no
Remarks:
prior to GLP implementation
Species:
rabbit
Strain:
other: Russian breed
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight: 1.5 - 2 kg
- Housing: single housing in V2A wire cages
- Diet: NAFAG, Gossau SO, rabbit food ad libitum
- Water: water ad libitum
Type of coverage:
occlusive
Preparation of test site:
other: clipped and scarified
Vehicle:
other: PEG 400
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- The substance was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made.
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 animals: 3 males, 3 females
Details on study design:
TEST SITE
A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. The test substance was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made.

REMOVAL OF TEST SUBSTANCE
The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it, on the basis of the following evaluation scheme.

SCORING SYSTEM:
Erythema and Eschar Formation:
No erythema; 0
Very slight erythema (barely perceptible); 1
Well defined erythema; 2
Moderate to severe erythema; 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth); 4
Total possible erythema score; 4

Edema Formation
No edema; 0
Very slight edema (barely perceptible); 1
Slight edema (edges of area well defined by definite raising; 2
Moderate edema (raised approximately 1 mm); 3
Severe edema (raised more than 1 mm and extending beyond area of exposure); 4
Total possible edema score; 4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Scarified skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Scarified skin
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Interpretation of results:
GHS criteria not met
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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Non-GLP non-guideline study, available as unpublished report, predates implementation of GLP and/or development of study guidelines, notable limitations in design and/or reporting. After application eye lids were held open for a few seconds instead of closed.
Qualifier:
according to guideline
Guideline:
other: The procedure adopted was the technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
GLP compliance:
no
Remarks:
prior to GLP implementation
Species:
rabbit
Strain:
other: Russion breed
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: single housing in V2A wire cages
- Diet: NAFAG, Gossau SG, rabbit food ad libitum
- Water: water ad libitum
- Only rabbits showing normal ophthalmic findings were included in the test.
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
Eyes of 3 female animals were rinsed 30 seconds after treatment. Eyes of 3 male animals were not rinsed.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 animals: 3 males, 3 females
Details on study design:
Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three female rabbits were each rinsed with 10 mL lukewarm water about 30 seconds after treatment.

SCORING SYSTEM: The reactions were appraised after 24 hours and after 2, 3, 4 and 7 days on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.

Evaluation of the Eye Reactions:
Cornea:
A. Opacity-degree of density (area most dense taken for reading):
No opacity; 0
Scattered or diffuse area, details of iris clearly visible; 1
Easily discernible translucent areas, details of iris slightly obscured; 2
Opalescent areas, no details of iris visible, size of pupil barely discernible; 3
Opaque, iris invisible; 4

B. Area of cornea involved:
One quarter (or less) but not zero; 1
Greater than one quarter, but less than half; 2
Greater than half, but less than three quarters; 3
Greater than three quarters, up to whole area; 4
A X B X 5
Total maximum = 80

Iris
A. Values
Normal; 0
Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive); 1
No reaction to light, hemorrhage, gross destruction (any or all of these); 2
A x 5

Conjunctivae:
A. Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris):
Vessels normal; 0
Vessels definitely injected above normal; 1
More diffuse/ deeper crimson red, individual vessels not easily discernible; 2
Diffuse beefy red; 3

B. Chemosis:
No swelling; 0
Any swelling above normal (includes nictitating membrane); 1
Obvious swelling with partial eversion of lids; 2
Swelling with lids about half closed; 3
Swelling with lids about half closed to completely closed; 4

C. Discharge:
No discharge; 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals); 1
Discharge with moistening of the lids and hairs just adjacent to lids; 2
Discharge with moistening of the lids and hairs, and considerable area around the eye; 3
(A + B + C) X 2
Total maximum = 20

TOOL USED TO ASSESS SCORE: slit-lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hour - 7 days
Score:
0
Max. score:
80
Remarks on result:
other: Rinsed eye
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hour - 7 days
Score:
0
Max. score:
10
Remarks on result:
other: Rinsed eye
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hour - 7 days
Score:
0
Max. score:
20
Remarks on result:
other: Rinsed eye
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hour - 7 days
Score:
0
Max. score:
80
Remarks on result:
other: Eyes not rinsed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hour - 7 days
Score:
0
Max. score:
10
Remarks on result:
other: Eyes not rinsed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hour - 7 days
Score:
0
Max. score:
20
Remarks on result:
other: Eyes not rinsed
Irritant / corrosive response data:
The irritation index was found to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion:

In a skin irritation patch test (pre-GLP) according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO), the skin irritating properties of the test substance was assessed. Therefor 6 Russian breed rabbits (3 male, 3 female) were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. The test substance was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it. The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0. Therefore, the test substance is considered as non-irritant to the skin of rabbits.

Eye irritation:

In an eye irritation test (pre-GLP; according AFDO guideline) 6 Russian breed rabbits (3 male, 3 female) amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days. The irritation index was found to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae. Therefore, the test substance is considered as non-irritant to the eye of rabbits.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for irritation under Regulation (EC) No. 1272/2008, as amended for the 13th time in Regulation (EU) 2018/1480.