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Diss Factsheets

Administrative data

Description of key information

The substance is not irritating to skin and eyes.

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:
Aug 10 - 17, 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: about 38 to 41 weeks
- Weight at study initiation: 4,05 (3,30 - 4,56) kg
- Housing: separately in cages type KK 017 (floor area: 75 x 54.5 = 4087 cm^2 , height: 38 cm; manufacturer: Hulskamp) on metal grids
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 20 °C
- Humidity (%): 53 to 89 %

IN-LIFE DATES: From: day 1 To: day 8
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5 mL of undiluted or diluted (16 % aqueous solution) test item was applied
Duration of treatment / exposure:
4 h
Observation period:
8 days
Number of animals:
6 (3m, 3f)
Details on study design:
TEST SITE
- Area of exposure: 4 cm2
- % coverage: 100 %
- Type of wrap if used: polyethylene foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible
Remarks:
after 5 days
Remarks on result:
other: with undiluted test item
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: with undiluted test item
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: with diluted test item
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: with diluted test item
Other effects:
No signs of systemic toxicity were detected. The body weight development was not different from that of untreated rabbits of the same age. All animals survived the 8-day observation period.
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study, the test material is evaluated as not irritating to the skin.
Executive summary:

The test material was tested for primary skin irritation in New Zealand White rabbits (Iva: NZW) in a GLP Study according to test guideline OECD 404. The test item was tested undiluted and as a 16 % aqueous solution. Six animals (3 males and 3 females) were used for this study. Aliquots of 0.5 mL of either the undiluted or diluted test item were given onto 4 cm2 patches and applied onto the left side of the shaved backs of each animal. The diluted test item was applied to the right side of each animal. The patches were wrapped by polyethylene foil under occlusive conditions. After 4 hours of occlusive exposure the patches were removed and any test item left was wiped off. The animals were investigated for skin alterations, clinivcal symptoms and body weight for a period of 8 days. Skin changes at the application sites were evaluated according to Draize (1959). The application of the undiluted test item to the intact dorsal skin of rabbits for 4 hours under occlusive conditions resulted in very slight skin irritation: The 24/48/72 hours values for erythema in the 6 animals were 0.0 in 5 animals and 1.0 in one animal (mean 0.17). The effects observed in the one animal were reversible and vanished on day 5. The 24/48/72 hours mean value for edema were 0.0 in all animals. Treatment with the 16 % aqueous solution of the test item did not result in any effect, i.e. the 24/48/72 mean values for erythema and edema in all 6 animals were 0.0. Based on the results of this study, the test material is evaluated as not irritating to the skin.

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:
May 18 to May 25, 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: 17 weeks
- Weight at study initiation: 2.69 (:,43 - 2.91) kg
- Housing: separately in cages type KK 017 (floor area: 75 x 54.5 = 4087 cm^2 , height: 38 cm; manufacturer: Hulskamp) on metal grids
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 24 °C
- Humidity (%): 44 to 67 %
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.1 ml Test item liquid (containing 40 % Eusolex 232 in water)
Duration of treatment / exposure:
1 h
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3 (2m, 1f)
Details on study design:
To ensure that only rabbits without ocular abnormalities were included in the study, 24 hours before treatment ophthalmological examinations were performed after instillation of 0.15 % fluorescein solution (Dr. Thilo & Co.) using an ophthalmoscope after Eisenhut (Basel).

SCORING SYSTEM: DRAIZE, J.H.: "Dermal toxicity", In.: Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics. Association of Food and Drug Officials of the USA (eds.), Baltimore (1959)

TOOL USED TO ASSESS SCORE: ophthalmoscope
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
No eye irritating potential could be detected, thus the test material should not be classified as eye irritant according to EU Regulation No. 1272/2008 and CLP.
Executive summary:

The primary eye irritation potential of Phenylbenzimidazole sulfonic acid was tested in 3 New Zealand White rabbits according to test guideline OECD 405. Aliquots of 0.1 mL of a liquid formulation consisting of 40 % active substance was instilled into the conjunctival sac of the left eye of each of 3 rabbits. The right eyes remained untreated and served as controls. The rabbits were investigated for eye irritation 1 hour after treatment and then daily for a period of 8 days. Effects on the cornea, iris and conjunctivae were evaluated according to the Draize scale (1959). After single instillation of 0.1 mL of a formulation consisting of 40 % Phenylbenzimidazole sulfonic acid into the conjunctival sac of the left eye, without rinsing, a very slight irritation (slight reddening) of the conjunctivae was observed in one rabbit only on day 1 of the study. Afterwards no irritation could be detected. No eye irritating potential could be detected, thus the test material should not be classified as eye irritant according to EU Regulation No. 1272/2008 and CLP.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The test substance was tested for skin and eye irritation/corrosion by applying the neutralized form (with triethanolamine or sodium hydroxide) to skin respectively eyes of rabbits in concentrations of 72 % and 10 % respectively. In none of the studies eye or skin irritation was observed.

Justification for classification or non-classification

In both in vivo tests on skin irritation and in an in vivo test on eye irritation no effects were observed on skin and eyes and thus the substance is not considered for skin or eye irritation/corrosion classification according to CLP (Regulation EC No 1272/2008).