REAKTIVE GELB F 97494

Endpoint summary

Description of key information

The substance did not cause irritation to skin or 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:

From October 16, 2001 to October 19, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline 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

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Remarks:

Crl:KBL(NZW)BR (N.Zeal.White)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH 88353 Kißlegg
- Body weight at start of study: 3.25–3.91 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery (room number 051).
- Diet: ssniff K-H (V2333), ad libitum and hay (approximately 15 g daily)
- Water: from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions
- Animal identification: Ear tags and cage numbering

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C (except short lasting deviations due to disturbances of air condition)
- Humidity: 50±20 % (except short lasting deviations due to disturbances of air condition)
- Photoperiod: 12 h light/dark cycle

IN-LIFE DATES: From: To: October 16, 2001 to October 19, 2001

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

deionized

Controls:

yes, concurrent no treatment

Amount / concentration applied:

500 mg per patch

Duration of treatment / exposure:

4 h

Observation period:

30-60 minutes as well as 24, 48 and 72 h after removal of the patches

Number of animals:

3 females

Details on study design:

ROUTE OF ADMINISTRATION: Dermal

FREQUENCY OF ADMINISTRATIONS: single dose

PREPARATION OF THE TEST SUBSTANCE:
Each animal was treated with 500 mg of test substance pasted with 0.4 mL deionized water.

TEST PROCEDURE:
About 24 h before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm². Only animals with intact skin were used. Each animal was treated with 500 mg of test substance pasted with 0.4 mL deionized water. The test substance was evenly distributed over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage. The exposure period was 4 h.

After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water. Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 h after removal of the patches.

Erythema, eschar formation and edema were evaluated numerically according to the score of DRAIZE. All other changes of the skin were recorded.

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 eschar formation (injuries in depth) preventing
grading of erythema...........................................................................................................4
Not assessable.....................................................................................................................*
Edema
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
Not assessable......................................................................................................................*

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of irritations were observed during the study.

Other effects:

No abnormalities detected during clinical observations.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the test substance was considered to be non-irritant to skin.

Executive summary:

A study was performed to assess the skin irritation potential of the test substance in Crl:KBL(NZW)BR female rabbits according to OECD Guideline 404, EPA OPPTS 870.2500 and EU Method B.4, in compliance with GLP.

 

500 mg of test substance pasted with 0.4 mL deionized water was evenly distributed over the whole surface of a cellulose patch on a piece of surgical plaster of 2.5 x 2.5 cm. The plaster was fixed to the prepared skin area of about 25 cm² and then covered with a semi-occlusive bandage. The patch was allowed to remain in contact with the skin for 4 h. After the exposure period, all remnants of test substance were carefully removed from the skin with warm tap water. Animals were scored for irritation reactions after 30 - 60 minutes, and at 24, 48 and 72 h.

No skin irritation was observed in treated animals.

 

Under the test conditions, the test substance was considered to be non-irritating to 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 October 23, 2001 to November 06, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Remarks:

Crl:KBL(NZW)BR (N.Zeal.White)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH 88353 Kißlegg
- Body weight at start of study: 2.4–3.1 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery (room number 051).
- Diet: ssniff K-H (V2333), ad libitum and hay (approximately 15 g daily)
- Water: from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions
- Animal identification: Ear tags and cage numbering

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C (except short lasting deviations due to disturbances of air condition)
- Humidity: 50±20 % (except short lasting deviations due to disturbances of air condition)
- Photoperiod: 12 h light/dark cycle

IN-LIFE DATES: From: To: October 23, 2001 to November 06, 2001

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

24 h

Observation period (in vivo):

1, 24, 48 , 72 h and and after 7 d following administration of the test substance.

Number of animals or in vitro replicates:

3 females

Details on study design:

ROUTE OF ADMINISTRATION: conjunctival

FREQUENCY OF ADMINISTRATIONS: single dose

PREPARATION OF THE TEST SUBSTANCE:
Each animal was treated with 100 mg of test substance


TEST PROCEDURE

About 24 h before the start of the study both eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01% fluorescein-sodium solution. Only animals without ocular abnormalities were used for the study.

0.1 mg of test substance was administered once to the conjunctival sac of the left eye of three rabbits. In each case the untreated eye served as a control. 24 h after administration the treated eyes were washed out thoroughly with isotonic saline at approximately 37°C. The eyes were also washed out at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed.

The eyes were examined 1, 24, 48 and 72 h after administration of the test substance. At 24 and 72 h and after 7 d, the eyes were further examined for corneal lesions under UV light after instillation of one drop of a 0.01% fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded when apparent. Since effects were still present in the eyes after 72 h, further examinations were carried out after 7 d.

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 d

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 d

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

1 h up to 72 h after administration the conjunctivae of the animals showed definitely injected blood vessels up to crimson colour. 1 h up to 24 h after administration the conjunctivae of the animals showed slight up to obvious swelling. Furthermore, two animals showed bleedings of the nictitating membrane from 24 h up to 72 h after administration. In addition to these observations, serous eye discharge discolored by the substance was noted. 7 d after administration all signs of irritation had disappeared.

Other effects:

No clinical signs of systemic toxicity were observed.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the test substance was considered to be not irritating to eyes.

Executive summary:

A study was conducted to assess the eye irritancy potential of the test substance in Crl:KBL(NZW)BR female rabbits according to OECD Guideline 405, EPA OPPTS 870.2400 and EU Method B.5, in compliance with GLP.

 

A single dose of 100 mg test substance was applied to the conjunctival sac of the left eye of each animal. The treated eyes were washed out 24 h after the administration of the test substance. The untreated eyes served in each case as a control.

 

Except for conjunctivae redness and chemosis which were fully reversible within 7 d, no severe irritating effects were observed. Further, no clinical signs of systemic toxicity were seen.

 

Under the test conditions, the test substance was considered to be not irritating to eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

A study was performed to assess the skin irritation potential of the test substance in Crl:KBL(NZW)BR female rabbits according to OECD Guideline 404, EPA OPPTS 870.2500 and EU Method B.4, in compliance with GLP. 500 mg of test substance pasted with 0.4 mL deionized water was evenly distributed over the whole surface of a cellulose patch on a piece of surgical plaster of 2.5 x 2.5 cm. The plaster was fixed to the prepared skin area of about 25 cm² and then covered with a semi-occlusive bandage. The patch was allowed to remain in contact with the skin for 4 h. After the exposure period, all remnants of test substance were carefully removed from the skin with warm tap water. Animals were scored for irritation reactions after 30 - 60 minutes, and at 24, 48 and 72 h. No skin irritation was observed in treated animals. Under the test conditions, the test substance was considered to be non-irritating to skin.

 

A study was conducted to assess the eye irritancy potential of the test substance in Crl:KBL(NZW)BR female rabbits according to OECD Guideline 405, EPA OPPTS 870.2400 and EU Method B.5, in compliance with GLP. A single dose of 100 mg test substance was applied to the conjunctival sac of the left eye of each animal. The treated eyes were washed out 24 h after the administration of the test substance. The untreated eyes served in each case as a control. Except for conjunctivae redness and chemosis which were fully reversible within 7 d, no severe irritating effects were observed. Further, no clinical signs of systemic toxicity were seen. Under the test conditions, the test substance was considered to be not irritating to eyes.