Reaction mass of (disodium 4-[[4-(acetylmethylamino)-2-sulphonatophenyl]amino]1-amino-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate and sodium sulphate and sodium chloride)

Endpoint summary

Description of key information

Skin: None of the animals showed any observable response to treatment throughout the 72 hours observation period
Eyes: Only mild conjunctival reactions were observed in three of six animals. No effects on corneae or irises.

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:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: early study pre-dating GLP-regulations but giving the relevant details of the study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

abraded and intact skin

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

other: Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.41

GLP compliance:

no

Remarks:

pre-dates GLP-regulation

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

no data

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: all

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

None of the animals showed any observable response to treatment throughout the 72 hours observation period

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item is considered to be non-irritant to rabbit skin.

Executive summary:

Primary irritation to the skin was measured by a patch test technique on the abraded and intact skin of the albino rabbit, clipped free of hair. A minimum of six subjects were used per skin tests.

Under a square patch such as surgical gauze measuring 1 inch x 1 inch, two single layers thick, 0.5 gram of the test substance were introduced. The test item was moistened with water.

The animals were immobilized with patches secured in place by adhesive tape. The entire trunk of the animals was then wrapped with an impervious material such as rubberized.cloth for the 24 -hour period of exposure.

After 24 hours exposure, the patches were removed and the resulting reactions were evaluated

None of the animals showed any observable response to treatment throughout the 72 hours observation period

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:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: early study before GLP, but reporting the relevant details

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

6 animals employed

Qualifier:

according to guideline

Guideline:

other: Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.42

GLP compliance:

no

Remarks:

pre-dates GLP-regulation

Species:

rabbit

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

100 mg / eye

Duration of treatment / exposure:

no washing

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

6

Details on study design:

Six albino rabbits are used for each test substance. Animal facilities for such procedures shall be so designed and maintained so to exclude sawdust, wood chips, or other extraneous materials that might produce eye irritation. Both eyes of each animal in the test group shall be examined before testing, and only those animals without eye defects or irritation shall be used. The animal is held firmly but gently until quiet. The test material is placed in one eye of each animal by gently pulling the lower Iid away from the eyeball to form a cup into which the test substance is dropped. The Iids are then gently held together for one second and the animal is released.
The other eye, remaining untreated, serves as a control.
For solids or pastes, 100 milligram of the test substance is used.
The eyes are not washed following instillation of test material.
The eyes are examined and the grade of ocular reaction is recorded at 24, 48 and 72 hours. Reading of reaction is facilitated by use of o binocular Ioupe, hand slit-lamp, or other expert means.
After the recording of observations at 24 hours, any or all eyes may be further examined after applying fluorescein. For this optional test, one drop of fluorescein sodium ophthalmic solution U.S.P. or equivalent is dropped directly on the cornea. After flushing out the excess fluorescein with sodium chloride solution U.S.P. or equivalent, injured areas of the cornea appear yellow; this is best visualized in a darkened room under ultra-violet illumination.

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 24 h

Score:

ca. 1

Max. score:

1

Reversibility:

not fully reversible within: 7 days

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1 to 7 days

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1 to 7 days

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 1 day

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 1 day

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

7 d

Score:

1

Reversibility:

not fully reversible within: 7 days

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item is considered to be "non-irritant" to the rabbit eye

Executive summary:

The procedure employed was tl:at prescribed by The Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.42.

On this occasion 100 mg of the test item was instilled into one eye of each animal, the other eye remaining untreated, served as a control.

The ocular reactions were scored by the method described by J. H . Draize in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" p51, 1959 and categorized from the mean values as recommended by the ETAD Sub-committee for Toxicology.

Mild conjunctival reactions only were observed in three animals. Three animals did not show any observable response to treatment throughout the 7 days observation period.

Maximum mean Draize score = 0.5

CONCLUSION The test item is considered to be "non-irritant" to the rabbit eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin: None of the animals showed any observable response to treatment throughout the 72 hours observation period Eyes: Only mild conjunctival reactions only were observed in three of six animals. No effects on corneae or irises.

Justification for selection of skin irritation / corrosion endpoint:
only available study

Justification for selection of eye irritation endpoint:
only available study

Justification for classification or non-classification

no classification

No relevant irritation effects were recorded.