Sodium sulphanilate

Endpoint summary

Description of key information

Key study: Skin irritation. OECD guideline and EU method. GLP study.
Based on the available results, the test substance is not classified as skin irritating.
Key study: Eye irritation OECD guideline and EU method. GLP study.
Based on the available results, the test substance is not classified as eye 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:

From 09 May 1995 to 16 May 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline and EU method. GLP study.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd., Wyton, Huntingdon, England
- Weight at study initiation: 3.9-4.3 kg
- Housing: The rabbits were individually housed in stainless steel cages with flat rod bases or plastic cages with perforated bases, under standardized conventional conditions.
- Diet (e.g. ad libitum): Standard diet "Ssniff K4", approx. 100-120 g per animal/day; once per day in the morning.
- Water (e.g. ad libitum): Tap water; ad libitum.
- Acclimation period: Approximately one week.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 ºC (higher when ambient temperature over 24 ºC)
- Humidity (%): 50-70%
- Air changes (per hr): 12-15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours, artificial illumination from 6 a.m. to 6 p.m.

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: the test substance was moistened with deionized water

Controls:

other: no control animals (the contralateral skin area not treated with test substance served as control)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of the pulverized test substance.

Duration of treatment / exposure:

Four hours

Observation period:

1, 24, 48 and 72 hours and 7 days

Number of animals:

Three animals

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: A patch was placed on the exposed area and held in place with a semiocclusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposed skin areas were carefully washed with water without altering the existing response or the integrity of the epidermis.
- Time after start of exposure: Four hours.

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 (R) to slight eschar formation (S) 4R or 4S

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

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

0

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

0

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

0

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

0

Table 1: Dermal irritation scores

 

	Erythema			Oedema
Animal No	1	2	3	1	2	3
after 24 h	0	0	0	0	0	0
after 48 h	0	0	0	0	0	0
after 72 h	0	0	0	0	0	0
Mean score 24 – 72 h	0			0

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The results of the exposure of the test substance to the skin indicate that the test substance may be regarded as not irritating to the skin.

Executive summary:

The acute skin irritation/corrosion study was performed according to the OECD Guideline No. 404 and EU Method B.4. The test item in the amount of 0.5 g was applied only once to the shaved skin of three animals. The exposure lasted four hours. Detailed clinical observations of the treated skin were performed 1, 24, 48 and 72 hours and 7 days after the end of the exposure. The results of the exposure of the test substance to the skin indicate that the test substance may be regarded 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:

From 09 May 1995 to 16 May 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline and EU method. GLP study.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: 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: Interfauna UK Ltd., Wyton, Huntingdon, England
- Weight at study initiation: 4.3-4.6 kg
- Housing: The rabbits were individually housed in stainless steel cages with flat rod bases or plastic cages with perforated bases, under standardized conventional conditions.
- Diet (e.g. ad libitum): Standard diet "Ssniff K4", approx. 100-120 g per animal/day; once per day in the morning.
- Water (e.g. ad libitum): Tap water; ad libitum.
- Acclimation period: About two weeks.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 ºC (higher when ambient temperature over 24 ºC)
- Humidity (%): 50-70%
- Air changes (per hr): 12-15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours, artificial illumination from 6 a.m. to 6 p.m.

Vehicle:

unchanged (no vehicle)

Controls:

other: no (the other eye remained untreated and served as control).

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µl of the pulverize test substance (equivalent to approximately 41 mg)

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48 and 72 hours and 7 days

Number of animals or in vitro replicates:

Three animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was rinsed with normal saline.
- Time after start of exposure: 24 hours

SCORING SYSTEM:
Cornea
Opacity: degree of density
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Nacreous area, no details of iris visible, size of pupil barely discernible 3
Completely opaque cornea, iris not discernible through the opacity 4

Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction 2

Conjunctivae
Erythema (redness)
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse, beefy redness 3

Chemosis
No swelling 0
Any swelling above normal (includes nictitating membranes) 1
Obvious swelling, with partial eversion of lids (ectropium) 2
Swelling, with lids about half closed 3
Swelling, with lids more than half closed 4

TOOL USED TO ASSESS SCORE: hand-slit lamp. To define epithelial damage, one drop of a 1% fluorescein solution was applied to the corneal surface 24 hours after administration of the test substance. Evaluation was performed by means of ultraviolet illumination in a darkened room and diffuse white illumination.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

0

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

0

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

0

Irritation parameter:

other: conjunctivae score: redness

Basis:

animal #1

Time point:

other: 24-72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

other: conjunctivae score: redness

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

other: conjunctivae score: redness

Basis:

animal #3

Time point:

other: 24-72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Table 1: Eye irritation scores

 

Animal	Region of eye	24 h	48 h	72 h	7 d
1	Cornea	0	0	0	0
	Iris	0	0	0	0
	Conjunctivae erythema	1	1	1	0
	Conjunctivae swelling	1	0	0	0
2	Cornea	0	0	0	0
	Iris	0	0	0	0
	Conjunctivae erythema	1	1	0	0
	Conjunctivae swelling	1	1	0	0
3	Cornea	0	0	0	0
	Iris	0	0	0	0
	Conjunctivae erythema	1	1	1	0
	Conjunctivae swelling	1	0	0	0

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The results of the exposure of the test substance to the eye indicate that the test substance may be regarded as not irritating to the eye.

Executive summary:

The acute ocular irritation/corrosion study was performed according to the OECD Guideline No. 405 and EU Method B.5. The test item in the amount of 0.1 mL was placed into the conjunctival sac of one eye of each of three rabbits. 24 hours after instillation of the test substance the treated eye was rinsed with normal saline. Eye irritation was scored and recorded at 1, 24, 48 and 72 hours and 7 days after the end of the exposure. The results of the exposure of the test substance to the eye indicate that the test substance may be regarded as not irritating to the eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Key study: Skin irritation. OECD guideline and EU method. GLP study.

Based on the available results, the test substance is not classified as skin irritating.

Key study: Eye irritation OECD guideline and EU method. GLP study.

Based on the available results, the test substance is not classified as eye irritating.

Justification for selection of skin irritation / corrosion endpoint:
Only one study available. Klimisch 1 and the study was carried out in accordance with internationally valid GLP principles.

Justification for selection of eye irritation endpoint:
Only one study available. Klimisch 1 and the study was carried out in accordance with internationally valid GLP principles.

Justification for classification or non-classification

Based on the available data, the substance is not classified as skin or eye irritating.

- skin irritation: 24-72 h scores:

erythema: 0

oedema: 0

- eye irritation: 24-72 h scores:

cornea: 0

iris: 0

conjunctivae redness < 2 and fully reversible

conjunctivae chemosis < 2 and fully reversible