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Description of key information

Not irritating to skin or eyes

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
other: “Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)
Version / remarks:
1965
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
Healthy New Zealand White rabbits (Porton- strain) aged 11-12 weeks with average body weights of 2.57 kg (males) and 2.19 Kgs. (femals), bred on the premises and maintained under a semi-barrier system. Six rabbits (3 males and 3 females) were acclimatized in the test area for one week prior to the start of the study.

ENVIRONMENTAL CONDITIONS
The rabbits were caged singly in. an experimental room maintained at a temperature of 20°C (± 1) and a relative humidity of 50-70%. Animals were exposed to artificial light for 10 hours daily from 08.00 18.00 hours. A commercial irradiated diet (Styles-Oxoid) was fed ad libitum. Sterile filtered water was available at all times.
Type of coverage:
occlusive
Preparation of test site:
other: shaved and slightly scarified
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
3 males and 3 females
Details on study design:
The test was carried out according to the method given in the “Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).
Twenty-tour hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10% of the total body surface. Two test sites lateral to the mid line of the back were used an each rabbit. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact.
10 g of the test compound was mixed with 10 ml of water to make a suspension of 20 ml, 1.0 ml of which was applied each test site on a 2.5 cm square gauze pad. These were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then covered by a 6" wide "Coban” self adhesive bandage in order to retain the test substance in dose contact with the skin.
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 and for any further period considered necessary up to 14 days.
The assessment of the macroscopic skin reaction was made according to the following grading system:

Score for skin irritation in rabbits (evaluation scheme)
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

Primary Irritation Score
0 Non irritating
0.1 - 0.5 Minimally irritating
0.6 - 1.5 Slightly irritating
1.6 - 3.0 Mildly irritating
3.1 - 5.0 Moderately irritating
5.1 - 6.5 Severely irritating
6.6 - 8.0 Extremely irritating






Irritation parameter:
primary dermal irritation index (PDII)
Basis:
other: The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4. (FHSLA § 191.11)
Time point:
other: 24/72 hours
Score:
1.5
Max. score:
8
Reversibility:
fully reversible
Remarks on result:
other: slightly irritating
Irritation parameter:
edema score
Remarks:
shaved
Basis:
mean
Time point:
24 h
Score:
0.83
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
shaved
Basis:
mean
Time point:
24 h
Score:
1.17
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
A slight to well-defined erythema and a very slight to slight oedema were seen an all rabbits 24 hours after application of the compound. By 72 hours all intact sites were normal but 4/6 abraded sites were still showing a slight reaction. These were normal by day 10. The primary Irritation score was 1.5.
Interpretation of results:
GHS criteria not met
Conclusions:
A slight to well-defined erythema and a very slight to slight oedema were seen an all rabbits 24 hours after application of the compound. By 72 hours all intact sites were normal but 4/6 abraded sites were still showing a slight reaction. These were normal by day 10. The primary Irritation score was 1.5.

According to GHS, the test substance is not irritating to skin.
Executive summary:

The skin irritation in albino rabbits after single application was performed to determine the irritant potency of the test item on the albino rabbit skin.The test was carried out according to the method given in the “Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).

The test was performed on 3 male rabbits and 3 female rabbits (New Zealand White rabbits), checked for normal skin conditions. Before treatment, the flanks of the rabbits were shaved and immediately before treatment, the shaven skin on one side was slightly scarified. A gauze patch bearing 1 g of the test substance was applied to the prepared abraded and intact skin. The patches were covered by an impermeable material. Patches were held in place for 24 hours.

A slight to well-defined erythema and a very slight to slight oedema were seen an all rabbits 24 hours after application of the compound. By 72 hours all intact sites were normal but 4/6 abraded sites were still showing a slight reaction. These were normal by day 10. The primary Irritation score was 1.5.

According to the GHS evaluation system, the test substance is not irritating to skin.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
BASF method
GLP compliance:
no
Species:
rabbit
Strain:
Himalayan
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Remarks:
pasted
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
20 hours
Observation period:
8 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: back

REMOVAL OF TEST SUBSTANCE
- Washing (if done): -
- Time after start of exposure: 20 h

OBSERVATION TIME POINTS
24 hours, 8 days

SCORING SYSTEM:
- Parameters evaluated: reddening, edema, scabbing, necrosis, scarification
- Descriptors: questionable, minimal, moderate, marked, without effect
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 8 days
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Interpretation of results:
other:
Remarks:
not irritating
Conclusions:
not irritating
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
other: "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animals
Healthy New Zealand White rabbits (Porton- strain) aged 11-12 weeks with average body weights of 2.57 kg (males) and 2.19 Kgs. (femals), bred on the premises and maintained under a semi-barrier system. Six rabbits (3 males and 3 females) were acclimatized in the test area for one week prior to the start of the study.

Husbandry•
The rabbits were caged singly in. an experimental room maintained at a temperature of 20°C (± 1) and a relative humidity of 50-70%. Animals were exposed to artificial light for 10 hours daily from 08.00 18.00 hours. A commercial irradiated diet (Styles-Oxoid) was fed ad libitum. Sterile filtered water was available at all times.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
30 second in 3 animals, 24 hours in 3 animals
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 male and 3 female rabbit
Details on study design:
The test was carried out in accordance with the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification.
The eyes of the experimental animals were examined, and found normal prior to the test. 100 mg. of the test compound were instilled into the conjunctival sec 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 approximately 200 mL of warm water 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 ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.. Corneal damage was assessed after staining with fluorescein.
Other effects / acceptance of results:
3 rinsed animals
3 non-rinsed animals
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 rinsed animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 non-rinsed animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 rinsed animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 non-rinsed animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 rinsed animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 non-rinsed animals
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 rinsed animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 non-rinsed animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
A very slight to slight conjunctival reaction was seen in all treated eyes one hour after application of the compound. Redness was still present in 4/6 eyes at 24 hours. These had returned to normal by 48 hours (2 eyes) and 72 hours (2 eyes).
Interpretation of results:
GHS criteria not met
Conclusions:
The test item is not irritating to eyes.
Slight conjunctival effects were seen 1 hour after test item instillation. This effect was avoided by rinsing of the eyes.
Executive summary:

An eye irritation study after single application was performed to determine the irritant potency of the test item on the rabbit eyes in New Zealand White rabbits. The test was carried out in accordance with the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification.

The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the 6 rabbits and the lids were held open for a few seconds. The right eye was not treated and served as a control. In three of the six rabbits approximately 30 seconds after treatment both eyes were rinsed with physiologic saline. The reactions were appraised with a slit lamp after 1 and 6 hours; 1; 2; and 3 days.

A very slight to slight conjunctival reaction was seen in all treated eyes one hour after application of the compound. Redness was still present in 4/6 eyes at 24 hours. These had returned to normal by 48 hours (2 eyes) and 72 hours (2 eyes).

In conclusion, the test item is not irritating to eyes.

Slight conjunctival effects were seen 1 hour after test item instillation. This effect was avoided by rinsing of the eyes.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
Himalayan
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg
- Concentration (if solution): NA
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
8 days
Details on study design:
OBSERVATION TIME POINTS
1 hour, 24 hours, 8 days

SCORING SYSTEM:
- Parameters evaluated: reddening, edema, scabbing, necrosis, turbidity, scarification
- Descriptors: questionable, minimal, moderate, marked, without effect
Irritation parameter:
cornea opacity score
Remarks:
test and control item
Basis:
mean
Time point:
other: 1 h/24 h/ 8 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
test and control item
Basis:
mean
Time point:
other: 1/24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
test and control item
Basis:
mean
Time point:
other: 8 d
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Remarks:
test and control item
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Remarks:
test and control item
Basis:
mean
Time point:
other: 14 h/8 d
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Interpretation of results:
other:
Remarks:
not irritating
Conclusions:
Vat Blue 20 is 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

Various studies for skin or eye irritating properties were conducted wit Vat Blue 20. In these studies, Vat Blue 20 was not irritating to skin and eyes.

Justification for classification or non-classification