Registration Dossier

Administrative data

Description of key information

Valid in-vivo studies for skin irritation/corrosion and eye irritation are available. No adverse effects are observed for skin- and eye irritation.

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:
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:
To one male and two female rabbits about 0.5 ml of undiluted Luprintan TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) was applied for 4 hours to the upper third of the back or flanks. At the end of the exposure period the test substance was removed with lutrol and lutrol/water 1:1. Readings according to Draize were done 30-60 min after removal of the test patches and 24, 48 and 72 hours after the beginning of the application.
GLP compliance:
not specified
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
Animals species: Rabbit / White Vienna
Animal breeder: Gaukler, D-6050 Offenbach, FRG
Acclimatisation: At least 8 days before the beginning of the study
Type of cage: Stainless steel wire mesh walk floors (40 cm x 51 cm)
No. animals per cage: 1
Room temperature/ The animals were housed in fully air-conditioned rooms (20 - 24°C; relative humidity 30 - 70°C).
relative humidity
Day/night rhythm: 12 hours / 12 hours
Drinking water: About 250 ml tap water per animal per day
Diet: Kliba 341
Clipping of the fur: At least 15 hours before the beginning of the study
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml on a test patch (2.5 cm x 2.5 cm)
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
1 male and 2 females
Details on study design:
Exposure period: 4 hours
Number of animals: 1 male and 2 female rabbits
Mean weight: male: 3.00 kg; female: 3.05 kg
Application area: 2.5 cm x 2.5 cm
Form of application: unchanged
Application volume: wetting of the test patch (2.5 cm x 2.5 cm) with the undiluted substance, and thus about 0.5 ml of the test liquid was absorbed
Application site: upper third of the back or flanks
Removal of test substance: at the end of the exposure period with lutrol and lutrol/water (1:1)
Observation period: 72 hours
Readings: 30 - 60 minutes after removal of the test patches and 24, 48 and 72 hours after the beginning of the application
Negative control: untreated skin sites of the same animal
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritant / corrosive response data:
Erythema and edema score = 0 at any time point (24, 48 and 72 hours).
Interpretation of results:
GHS criteria not met
Conclusions:
No erythema and no edema was found at any time point (24, 48 and 72 hours).
Executive summary:

To one male and two female rabbits about 0.5 ml of undiluted Luprintan TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) was applied  for 4 hours to the upper third of the back or flanks. At the end of the exposure period the test substance was removed with lutrol and lutrol/water 1:1. Readings according to Draize were done 30-60 min after removal of the test patches and 24, 48 and 72 hours after the beginning of the application. No erythema and no edema was found at 24, 48 and 72 hours. Therefore Luprintan TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) is not skin irritating.

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
To one male and two female rabbits about 0.1 ml of undiluted Luprintan TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) was applied to the conjunctival sac of the right eyelid. The substance was not washed out. Readings according to Draize were done after 1, 24, 48 and 72 hours after the application.
GLP compliance:
not specified
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
Animals species: Rabbit / White Vienna
Animal breeder: Gaukler, D-6050 Offenbach, FRG
Acclimatisation: At least 8 days before the beginning of the study
Type of cage: Stainless steel wire mesh walk floors (40 cm x 51 cm)
No. animals per cage: 1
Room temperature/ The animals were housed in fully air-conditioned rooms (20 - 24°C; relative humidity 30 - 70°C).
relative humidity
Day/night rhythm: 12 hours / 12 hours
Drinking water: About 250 ml tap water per animal per day
Diet: Kliba 341
Clipping of the fur: At least 15 hours before the beginning of the study
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml (unchanged)
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Duration of post- treatment incubation (in vitro):
None
Number of animals or in vitro replicates:
1 male and 2 female rabbits
Details on study design:
Number of animals: 1 male and 2 female rabbits
Mean weight: male: 2.79 kg; female: 3.12 kg
Application volume: 0.1 ml (unchanged)
Application site: single application to the conjunctival sac of the right eyelid; the substance was not washed out
Observation period: 72 hours
Readings: 1, 24, 48 and 72 hours after the application
Negative control: untreated eye
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: score = 0 at any time point
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritant / corrosive response data:
The cornea, iris, conjunctivae and chemosis score was 0 at 24, 48 and 72 hours.
Interpretation of results:
GHS criteria not met
Conclusions:
The cornea, iris, conjunctivae and chemosis score was 0 at 24, 48 and 72 hours.
Executive summary:

To one male and two female rabbits about 0.1 ml of undiluted Luprintan TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) was applied to the conjunctival sac of the right eyelid. the substance was not washed out. Readings according to Draize were done after 1, 24, 48 and 72 hours after the application. The cornea, iris, conjunctivae and chemosis score was 0 at 24, 48 and 72 hours. Therefore Luprintan TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) is not irritating to the eyes.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

In valid studies equivalent or similar to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and OECD Guideline 405 (Acute Eye Irritation / Corrosion) TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) was not irritating.

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is therefore not justified.