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Diss Factsheets

Administrative data

Description of key information

not irritating for skin
not irritating for eyes

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment. not GLP compliant
Qualifier:
equivalent or similar to guideline
Guideline:
other: Guidelines of the United States Environmental Pr otection Agency (EPA), Paragraph 163.81-5 "Primary dermal irritaion study", Federal Register, Vol 43 No. 163, August 22, 1978.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Animals were housed individually in metal cages.The animal room was air conditionned: temperature 22±3° C, relative humidity 55+15%; 12 hours light/day, approximately15 air changes/h.Source: New Zealand White Rabbits, Kleintierfarm Madoerin AG, CH-4414 FuellinsdorfRabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland),and water were provided ad libitum.
Type of coverage:
occlusive
Preparation of test site:
shaved
Controls:
no
Amount / concentration applied:
0.5 ml of test material
Duration of treatment / exposure:
24 h treatment
Observation period:
24h, 48h, 72h, 4 and 7 days
Number of animals:
3 male / 3 female
Details on study design:
24 hours before treatement the flanks of the rabbits were shaved with an electric clipper (approximately 6 sq.cm each) and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "Schroepfschnaepper", Aesculap, Switzerland. Gauze patches soaked (or loaded) with 0.5 ml of the test material were applied to the prepared abraded and intact skin.The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressing s were removed after 24 hours.The skin reaction was assessed upon removal and during a subsequent observation period of 7 days on the basis of the following evaluation scheme.
Irritation parameter:
erythema score
Basis:
animal: 20,21, 22,23,24
Time point:
other: mean score of 24, 48, 72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no skin reaction observed
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal: 19
Time point:
other: mean score of 24, 48, 72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal: 20,22,23,24
Time point:
other: mean score of 24, 48, 72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no skin reaction observed
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal: 19
Time point:
other: mean score of 24, 28, 72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal: 21
Time point:
other: mean score of 24, 48, 72h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: intact skin
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
since no animals were observed an average of erythema and eschar or edema more than 2, the sample is classified as not irritant for skin.
Executive summary:

The substance has been tested for skin irritation with 6 New Zealand white rabbits with an occlusive method. After 7 days of observation no rabbit shows signs of erythema or edema. The substance is classified as non-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, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment. not GLP compliant
Qualifier:
equivalent or similar to guideline
Guideline:
other: Guidelines of the United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study", Federal Register, Vol. 43 No. 163 August 22, 1978.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Initial Body Weight Range: 2 - 3 kgsHusbandry: Animals were housed individually in metal cages. The animal room was air conditioned: temperature 22±3° C, relative humidity 55±15%; 12 hours light/day, approximately 15 air changes/h.Adaptation Period: 4 daysDiet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland),and water were provided ad libitum
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
0-1 ml
Duration of treatment / exposure:
30 s
Observation period (in vivo):
7 dyas
Number of animals or in vitro replicates:
3 male / 3 female
Details on study design:
The test material in an amount of 0.1 ml was inserted in the conjunctival sac of the left eye of the rabbits and the lids were gently closed for 15 seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was flushed with 10 ml of sterile physiological saline. The eye irritation was assessed with a slit-lamp at 24, 48, 72 hours and 4 and 7 days after treatment and was scored for each individual rabbit.
Irritation parameter:
cornea opacity score
Basis:
animal: 19
Time point:
other: mean score 24, 48, 72 h
Score:
ca. 0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: unrinsed eyes
Irritation parameter:
cornea opacity score
Basis:
animal: 20
Time point:
other: mean score 24, 48, 72h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: unrinsed eyes
Irritation parameter:
cornea opacity score
Basis:
animal: 21
Time point:
other: mean score 24, 48, 72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
other: unrinsed eye
Irritation parameter:
cornea opacity score
Basis:
animal: 22
Time point:
other: mean score 24, 48, 72 h
Score:
ca. 0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: rinsed eyes
Irritation parameter:
cornea opacity score
Basis:
animal: 23, 24
Time point:
other: mean score 24, 48, 72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
other: rinsed eyes
Irritation parameter:
iris score
Basis:
animal: 19,20,21
Time point:
other: mean score 24, 48, 72h
Score:
ca. 0
Max. score:
4
Remarks on result:
other: unrinsed eyes
Irritation parameter:
iris score
Basis:
animal: 22,23,24
Time point:
other: mean score 24, 48, 72h
Score:
ca. 0
Max. score:
4
Remarks on result:
other: rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
animal: 19,20
Time point:
other: mean score 24, 48, 72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: unrinsed eyes
Irritation parameter:
conjunctivae score
Basis:
animal: 21
Time point:
other: mean score 24, 48, 72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: unrinsed eyes
Irritation parameter:
conjunctivae score
Basis:
animal: 22
Time point:
other: mean score 24, 48, 72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
animal: 23
Time point:
other: mean score 24, 48, 72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
animal: 24
Time point:
other: mean score 24, 48, 72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
other: rinsed eyes
Irritation parameter:
chemosis score
Basis:
animal: 19,20,21
Time point:
other: mean score 24, 48, 72 h
Score:
ca. 0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: unrinsed eyes
Irritation parameter:
chemosis score
Basis:
animal: 22
Time point:
other: mean score 24, 48, 72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: rinsed eyes
Irritation parameter:
chemosis score
Basis:
animal: 23
Time point:
other: mean score 24, 48, 72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: rinsed eyes
Irritation parameter:
chemosis score
Basis:
animal: 24
Time point:
other: 24, 48, 72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: rinsed eyes
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
not irritant for eye
Executive summary:

Method

The study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit. The method followed is the Guidelines of the United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study", Federal Register, Vol. 43 No. 163 August 22, 1978.

The test material in an amount of 0.1 ml was inserted in the conjunctival sac of the left eye of the rabbits and the lids were gently closed for 15 seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was flushed with 10 ml of sterile physiological saline. The eye irritation was assessed with a slit-lamp at 24, 48, 72 hours and 4 and 7 days after treatment and was scored for each individual rabbit.

 

 

Results

The test material produced a minimal cornea irritation on 3/6 animals and minimal conjunctival irritation (redness) on 5/6 animals. . All treated eyes appeared normal at the 72-hour observation.

 

 

Conclusion

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all animals.

Therefore the substance does not meet the criteria to be classified as eye irritating.

 

In conclusion, the test item can be not classified as irritating, according to the CLP Regulation (EC 1272/2008).

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

One study (Huntsman, 1985) has been chosen as key study for the skin irritation endpoint.

The test follows the Guidelines of the United States Environmental Pr otection Agency (EPA), Paragraph 163.81-5 "Primary dermal irritaion study", Federal Register, Vol 43 No. 163, August 22, 1978. and it was performed on Acid Violet 054.

0.5 ml of test material were applied to intact and abraded skin of rabbits and removed after 24 hours. Observations were made for 7 days.

Since no animals were observed an average of erythema and eschar or edema more than 2, the tested substance is classified as not irritant for skin.

 

Another study (Huntsman, 1975) is available for Acid Violet 054 and was used as supporting. 

The test follows the guideline "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965) and it was performed on Acid Violet 054.

10g of the test compound was mixed with 10ml of water to make a solution of 15ml, 0.75ml of which was applied to each test site on a 2.5 cm square gauze pad.

After 24 hours the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 hours.

Since no animals were observed an average of erythema and eschar or edema more than 2, the sample is classified as not irritant for skin.

A summary (Dystar, 1977) is also available for Acid Violet 054, confirming that Acid Violet 054 is not irritant for skin.

 

 

 

Eye irritation:

One study (Huntsman, 1985) has been chosen as key study for the eye irritation endpoint.

The test follows the Guidelines of the United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study", Federal Register, Vol. 43 No. 163 August 22, 1978 and it was performed on Acid Violet 054.

The test material in an amount of 0.1 ml was inserted in the conjunctival sac of the left eye of the rabbits and the lids were gently closed for 15 seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was flushed with 10 ml of sterile physiological saline. The eye irritation was assessed with a slit-lamp at 24, 48, 72 hours and 4 and 7 days after treatment and was scored for each individual rabbit.

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all animals.

Therefore the substance does not meet the criteria to be classified as eye irritant.

Another study (Huntsman, 1975) is available for Acid Violet 054 and was used as supporting. 

The test follows the guideline U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965) and it was performed on Acid Violet 054.

100mg of the test compound were instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute.

The rabbits were examined 1, 24, 48 and 72 hours after application of the test compound and for any further period that was considered necessary.

The test material produced a cornea irritation on 3/6 animals, conjunctival irritation (redness) on all the animals and minimal chemosis irritation on all animals. Even if there is a minimal irritation for all the aspects investigated , all treated eyes appeared normal at the 72-hour observation.

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, equal to 2 for conjunctival redness and lower than 2 for oedema, in at least 2/3 animals.

Therefore the substance does not meet the criteria to be classified as eye irritant.

A summary (Dystar, 1977) is also available for Acid Violet 054, confirming that acid Violet 054 is not irritant for eyes.


Justification for selection of skin irritation / corrosion endpoint:
The study is well described and assesses the end point completely

Justification for selection of eye irritation endpoint:
The study is well described and assesses the end point completely

Justification for classification or non-classification

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

In the key study, the mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in at least 2 of 3 animals for both erythema/eschar and oedema reactions.

According to the CLP Regulation (EC 1272/2008) substances that have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes) 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 values from gradings at 24, 48 and 72 hours recorded in the key study were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all animals in the key study.

 

In conclusion, the substance is not classified for the eye/skin irritation, according to the CLP Regulation (EC 1272/2008).