Registration Dossier

Administrative data

Description of key information

Skin Irritation:

The dye was tolerated without irritation by all rabbits (index = 0). Under the test conditions described under FDA guidelines in the patch test, The test chemical can be assessed as not irritating to skin.

Eye Irritation:

After application of Solvent Blue 122, the highest irritation index of 16 was determined after 7 hours. According to the classification, the test chemical was therefore assessed to be slightly irritating to the 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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
data is from experimental reports
Qualifier:
according to
Guideline:
other: "1500.41 in Federal Register 38, No. 917, 27, 9, 173, P 27019" Guidelines
Qualifier:
according to
Guideline:
other: FDA Guidelines
Principles of method if other than guideline:
A test for skin compatibility was performed to assess the dermal irritation potential of the test chemical
GLP compliance:
not specified
Species:
rabbit
Strain:
other: SPF-albino-Himalayan rabbit strain Hoe: HIMK (SPFWiga)
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5-2.0 kg
- Housing:The animals were kept in individual cages
- Diet (e.g. ad libitum): compound feed ERKA 8300 of feed plants Robert Koch oHG / Hamm, ad libitum
- Water (e.g. ad libitum): water, ad libitum


IN-LIFE DATES: From: 5.9.1977 To: 8.9. 1977
Type of coverage:
occlusive
Preparation of test site:
shaved
Remarks:
intact and scarified skin
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
500 mg of the powdered dye
Duration of treatment / exposure:
24 hours
Observation period:
after removal of patch 24-hour value) and 48 and 72 hours after the start of the test.
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: flank skin
- % coverage: 3 × 3 cm square area
- Type of wrap if used: adhesive strip

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data available
- Time after start of exposure: no data available

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : after removal of patch 24-hour value) and 48 and 72 hours after the start of the test.

SCORING SYSTEM:
- Method of calculation: Based on the findings, the irritation index was determined according to the method described under "1500.41 in Federal Register 38, No. 917, 27, 9, 173, PG 27019"
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
8
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The dye was tolerated without irritation by all rabbits (index = 0)
Interpretation of results:
other: not irritating
Conclusions:
The dye was tolerated without irritation by all rabbits (index = 0). Under the test conditions described under FDA guidelines in the patch test, The test chemical can be assessed as not irritating to skin.
Executive summary:

A test for skin compatibility was performed to assess the dermal irritation potential of the test chemical. The test was performed according to the "1500.41 in Federal Register 38, No. 917, 27, 9, 173, P 27019" and FDA Guidelines.

6 SPF-albino-Himalayan rabbit strain Hoe: HIMK (SPFWiga) were used for the study. The flank skin of 6 rabbits was depilated with an electric hair trimmer on two adjacent spots on a 3 × 3 cm area respectively. Either one of the clipped skin spots was additionally scarified using a scrape cutter. On 2.5 * 2.5 cm coarse lids of surgical gauze, 500 mg of the powdered dye was applied and glued to the prepared skin areas by means of an adhesive strip. The patches were covered by an infectious, impermeable, 6-8 cm wide PVC foil and then wrapped in an elastic permanent bandage. The exposure time was 24 hours.The dermal reactions were observed and scored after removal of the patches (24 hours) and 48 and 72 hours after the start of the test.

The dye was tolerated without irritation by all rabbits (index = 0). Under the test conditions described under FDA guidelines in the patch test, the test chemical can be assessed as not 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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
data is from experimental reports
Qualifier:
according to
Guideline:
other: FDA Guidelines(Federal Register Vol. 38, No. 187, S 27019, 1973)
Principles of method if other than guideline:
The mucous membrane compatibility of the test chemical was assessed in rabbits
GLP compliance:
not specified
Species:
rabbit
Strain:
other: SPF-albino-Himalayan rabbit strain Hoe: HIMK (SPFWiga)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5-2.0 kg
- Housing:The animals were kept in individual cages
- Diet (e.g. ad libitum): compound feed ERKA 8300 of feed plants Robert Koch oHG / Hamm, ad libitum
- Water (e.g. ad libitum): water, ad libitum


IN-LIFE DATES: From: 5.9.1977 To: 8.9. 1977
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg of the powdered dye
Duration of treatment / exposure:
single application
Observation period (in vivo):
The assessment was performed 1,7,24,48 and 72 hours after the treatment with the help of a magnifying glass.
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data available
- Time after start of exposure: no data available

SCORING SYSTEM:The ocular lesions were observed and scored according to the classification given in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin, Texas, p. 51, 1975".

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: The assessment was performed 1,7,24,48 and 72 hours after the treatment with the help of a magnifying glass. After collecting the 24-hour report, all eyes were spooled with physiological saline solution. After 48 hours and 72 hours, after instillation of a drop of fluorescein sodium in the dilution 1: 10000 = 0.001%.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 hours
Score:
16
Max. score:
110
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
After application of the powdered dye, the highest irritation index of 16 was determined after 7 hours. According to the classification listed in the annex, the dye is therefore slightly irritating to the mucosa.
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
After application of the test chemical, the highest irritation index of 16 was determined after 7 hours. According to the classification, the test chemicalwas therefore assessed to be slightly irritating to the eyes.
Executive summary:

A test for mucous membrane compatibility of the test chemical was performed in rabbits. The test was performed according to the "1500.41 in Federal Register 38, No. 917, 27, 9, 173, P 27019" and FDA Guidelines.

6 SPF-albino-Himalayan rabbit strain Hoe: HIMK (SPFWiga) were used for the study. Single application of 100 mg of the powdered dye was instilled into the left conjunctival sac of 6 rabbits and the right eye remained untreated and served as control. The assessment for ocular lesions was performed 1, 7, 24, 48 and 72 hours after the treatment with the help of a magnifying glass. After collecting the 24-hour report, all eyes were spooled with physiological saline solution. After 48 hours and 72 hours, after instillation of a drop of fluorescein sodium in the dilution 1: 10000 = 0.001%. The ocular lesions were observed and scored according to the classification given in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin, Texas, p. 51, 1975".

For the determination of the irritation index, the evaluations of the cornea (a), the iris (b) and the conjunctiva (c) are added for each rabbit at the respective reading time. The average value of the values ​​of all rabbits is calculated at the corresponding reading time. The highest index determined at one of the reading times is used for grading.

After application of the test chemical, the highest irritation index of 16 was determined after 7 hours. According to the classification, the test chemicalwas therefore assessed to be slightly irritating to the eyes.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

A test for skin compatibility was performed to assess the dermal irritation potential of the test chemical. The test was performed according to the "1500.41 in Federal Register 38, No. 917, 27, 9, 173, P 27019" and FDA Guidelines.

6 SPF-albino-Himalayan rabbit strain Hoe: HIMK (SPFWiga) were used for the study. The flank skin of 6 rabbits was depilated with an electric hair trimmer on two adjacent spots on a 3 × 3 cm area respectively. Either one of the clipped skin spots was additionally scarified using a scrape cutter. On 2.5 * 2.5 cm coarse lids of surgical gauze, 500 mg of the powdered dye was applied and glued to the prepared skin areas by means of an adhesive strip. The patches were covered by an infectious, impermeable, 6-8 cm wide PVC foil and then wrapped in an elastic permanent bandage. The exposure time was 24 hours. The dermal reactions were observed and scored after removal of the patches (24 hours) and 48 and 72 hours after the start of the test.

The dye was tolerated without irritation by all rabbits (index = 0). Under the test conditions described under FDA guidelines in the patch test, the test chemical can be assessed as not irritating to skin.

Eye Irritation:

A test for mucous membrane compatibility of the test chemical was performed (Sustainability Support Services (Europe) AB has letter of access, 1977) in rabbits. The test was performed according to the "1500.41 in Federal Register 38, No. 917, 27, 9, 173, P 27019" and FDA Guidelines.

6 SPF-albino-Himalayan rabbit strain Hoe: HIMK (SPFWiga) were used for the study. Single application of 100 mg of the powdered dye was instilled into the left conjunctival sac of 6 rabbits and the right eye remained untreated and served as control. The assessment for ocular lesions was performed 1, 7, 24, 48 and 72 hours after the treatment with the help of a magnifying glass. After collecting the 24-hour report, all eyes were spooled with physiological saline solution. After 48 hours and 72 hours, after instillation of a drop of fluorescein sodium in the dilution 1: 10000 = 0.001%. The ocular lesions were observed and scored according to the classification given in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin, Texas, p. 51, 1975".

For the determination of the irritation index, the evaluations of the cornea (a), the iris (b) and the conjunctiva (c) are added for each rabbit at the respective reading time. The average value of the values ​​of all rabbits is calculated at the corresponding reading time. The highest index determined at one of the reading times is used for grading.

After application of the test chemical, the highest irritation index of 16 was determined after 7 hours. According to the classification, the test chemical was therefore assessed to be slightly irritating to the eyes.

Justification for classification or non-classification

Available studies indicate a possibility of the test chemical to cause eye irritation but no dermal irritation. Hence, comparing the annotations with the CLP regulation, the test chemical can be classified under the category “Not Classified” for skin irritation and “Category 2” for eye irritation.