Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin irritation/Corrosion:

Pigment red 202 (not specified form): not irritating (OECD 404)

Structure analogue: Pigment red 122 (nano form): not irritating (OECD 404)

Structure analogue: Pigment violet 19 (not specified form): not irritating

Structure analogue: Pigment red 209 (nano form): not irritating

Eye irritation:

Pigment red 202 (not specified form): not irritating (EPA-TSCA 40 CFR 798)

Structure analogue: Pigment red 122 (nano form): not irritating (OECD 405)

Structure analogue: Pigment violet 19 (nano form): not irritating (OECD 405)

Structure analogue: Pigment red 209 (nano form): not irritating

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:
key study
Study period:
From 28 JUL 1992 to 31 JUL 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: EPA-TSCA 40 CFR 798
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- 4 male /2 female animals tested
- Source: Ace animals
- Weight at study initiation: 2 to 2.6 kg
- Housing: 1/ cage in suspended
- Diet: Fresh purina rabbit chow (Diet #5321) was provided daily
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light):12 /12

4 male /2 female animals tested
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 g was pasted with distilled water
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
6 (4 male/ 2 female)
Details on study design:
TEST SITE
- Area of exposure: 6 cm² covered with gauze patch
- Type of wrap if used: semiocclusive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently washung with distilled water
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD TG 404
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
- there were no edema or erythema detectable (score 0) at any time point in any animal
Other effects:
During the whole testing period the skin at the dose site remained purple coloured. One animal showed systemic effects (diarrhea and soiled anogenital region) at the 24 and 48 hour reading which disapeared until the 72 hour reading.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material 2, 9-Dichloroquinacridone is not irritating to skin under these test conditions. The test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

Test material 2, 9-Dichloroquinacridone was subject to an acute dermal irritation/corrosion test in 6 New Zealand white rabbits similar to OECD TG 404. Beside the purple staining of the dose site, no relevant skin reactions occurred during the 4 h exposure to 500 mg of test item (pasted with distilled water) as well as during the following 72 h observation period. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 June 2005 to 10 August 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study meets or exceeds the requirements of OECD Guideline 404 and EU Method B.4
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
A gauze patch of approximately 4 cm x 4 cm (instead of 6 cm2) was used to guarantee good contact and uniform distribution of the test substance on the skin
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
as above
GLP compliance:
yes (incl. QA statement)
Remarks:
Study in compliance with Swiss Ordinance relating to GLP, which is based on OECD Principles of GLP
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Animal specifics: SPF
- Source: Charles River Laboratories, L'Arbresle, France
- Age at study initiation: 12 weeks (male), 12-13 weeks (females)
- Weight at study initiation: 2741 g for the male, 2873 g and 2674 g for the two females, all within the normal range of variability
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): standard laboratory diet ad libitum
- Water (e.g. ad libitum): community tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C (air-condition)
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml of purified water were used to moisten the test item
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approximately 4 cm x 4 cm
- Type of wrap if used: surgical gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with lukewarm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
as in EU Method B.4, assessed approximately 1, 24, 48, and 72 h after the romoval of the test item as well as after 7, 10 and 14 d
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h after treatment
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Apart from animal #2 at 24 h, all other scores (oedema or erythema) were 0 at all time points in all animals (see below for individual data).
Other effects:
No clinical signs or effects on body weight were observed. Erythema scores could not be assessed in all animals at 1 h due to marked staining produced by the test item

Animal number

Sex 

Evaluation interval (after removal of dressing )

Erythema score

Oedema score 

#1

1 hour 

not assessible due to staining

#2

F

0

#3

F

0

#1 

24 hours

0

#2

F

1

0

#3

F

0

0

#1

M

48 hours

0

0

#2

F

0

0

#3

F

0

0

#1

M

72 hours 

0

0

#2

F

0

0

#3

0

0

#1

M

7 days 

0

0

#2

F

0

0

#3

F

0

0

#1

M

10 days

0

0

#2

F

0

0

#3

F

0

0

#1

M

14 days

0

0

#2

F

0

0

#3

F

0

0

Interpretation of results:
not irritating
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test item is not irritating to skin under these test conditions.
Executive summary:

The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 0.00, 0.33 and 0.00, respectively and the mean oedema score was 0.00 for all three animals.

The application of the test item to the skin resulted in mild, early-onset and transient signs of irritation such as redness. These effects were reversible and were no longer evident 48 hours after treatment for all animals. However, staining by the red test item prevented the assessment of a possible erythema in all animals one hour after treatment. The slight to marked staining of the treated skin was noted in all animals throughout the whole study, effectively. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.

Thus, the test item did not induce significant or irreversible damage to the skin.

Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).

4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13).
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
- there were no edema or erythema detectable (score 0) at any time point in any animal
Other effects:
During the whole testing period the skin at the dose site remained purple coloured. One animal showed systemic effects (diarrhea and soiled anogenital region) at the 24 and 48 hour reading which disapeared until the 72 hour reading.
Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: CLP regulation
Conclusions:
The toxicity profile of Pigment Red 202 is assessed based on analogue approaches:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material 2, 9-Dichloroquinacridone is not irritating to skin under these test conditions. The test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

Test material 2, 9-Dichloroquinacridone was subject to an acute dermal irritation/corrosion test in 6 New Zealand white rabbits similar to OECD TG 404. Beside the purple staining of the dose site, no relevant skin reactions occurred during the 4 h exposure to 500 mg of test item (pasted with distilled water) as well as during the following 72 h observation period. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).

4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13).
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h after treatment
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Apart from animal #2 at 24 h, all other scores (oedema or erythema) were 0 at all time points in all animals (see below for individual data).
Other effects:
No clinical signs or effects on body weight were observed. Erythema scores could not be assessed in all animals at 1 h due to marked staining produced by the test item
Interpretation of results:
GHS criteria not met
Conclusions:
The toxicity profile of Pigment Red 202 is assessed based on analogue approaches:
According to the classification criteria of Regulation (EC) No 1272/2008 the test item is not irritating to skin under these test conditions.
Executive summary:

The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 0.00, 0.33 and 0.00, respectively and the mean oedema score was 0.00 for all three animals.

The application of the test item to the skin resulted in mild, early-onset and transient signs of irritation such as redness. These effects were reversible and were no longer evident 48 hours after treatment for all animals. However, staining by the red test item prevented the assessment of a possible erythema in all animals one hour after treatment. The slight to marked staining of the treated skin was noted in all animals throughout the whole study, effectively. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.

Thus, the test item did not induce significant or irreversible damage to the skin.

Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.

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:
key study
Study period:
6 October 1998 to 13 November 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with OECD Guideline 405 and EU Method B.5
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kißlegg, Germany
- Weight at study initiation: 3.51-3.91 kg
- Housing: separate cages arranged in a battery in fully air-conditioned rooms
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
One administration (for times of removal of the test substance see below)
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
- Application of the substance to the conjunctival sac of the left eye of each animal

REMOVAL OF TEST SUBSTANCE
- Washing: Washing with isotonic saline at approx. 37 °C 24 h after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution (24 and 72 h after administration) took place
- Time after start of exposure: see above

TOOL USED TO ASSESS SCORE: fluorescein-sodium, under UV light
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: effects observed at 1 hour, but reversible by 24 hour observation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation

Animal no. -- observation time -- cornea opacity -- cornea area -- iris -- conjunctiva redness -- conjunctiva chemosis -- conjunctiva discharge

311 -- 1 hour ---- 0 -- 0 -- 0 -- 2 -- 1 -- 1

311 -- 24 hours -- 0 -- 0 -- 0 -- 1 -- 0 -- 0

311 -- 48 hours -- 0 -- 0 -- 0 -- 0 -- 0 -- 0

311 -- 72 hours -- 0 -- 0 -- 0 -- 0 -- 0 -- 0

314 -- 1 hour -- --0 -- 0 -- 0 -- 1 -- 0 -- 0

314 -- 24 hours -- 0 -- 0 -- 0 -- 1 -- 0 -- 0

314 -- 48 hours -- 0 -- 0 -- 0 -- 0 -- 0 -- 0

314 -- 72 hours -- 0 -- 0 -- 0 -- 0 -- 0 -- 0

315 -- 1 hour ---- 0 -- 0 -- 0 -- 1 -- 0 -- 0

315 -- 24 hours -- 0 -- 0 -- 0 -- 1 -- 0 -- 0

315 -- 48 hours -- 0 -- 0 -- 0 -- 0 -- 0 -- 0

315 -- 72 hours -- 0 -- 0 -- 0 -- 0 -- 0 -- 0

Mean individual scores after 24, 48 and 72 hours for animal no. -- corneal opacity -- iris -- conjunctivae redness -- conjunctivae chemosis

311 -- 0.0 -- 0.0 -- 0.3 -- 0.0

314 -- 0.0 -- 0.0 -- 0.3 -- 0.0

315 -- 0.0 -- 0.0 -- 0.3 -- 0.0

Interpretation of results:
not irritating
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to eyes under these test conditions.
Executive summary:

A study according to OECD Guideline 405 and EU Method B.5 was performed to investigate the irritation potential to the rabbit eye.

One and 24 hours after treatment the conjunctivae of the animals showed definitely injected blood vessels up to a diffuse crimson red colour. Additionally, a very slight swelling and slight from substance coloured eye discharge were observed in one animal one hour after treatment. Fourty-eight hours after treatment all signs of irritation were reversible.

As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is not irritating to eyes and has not to be classified for eye irritation.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2 AUG 1988 to 5 AUG 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD TG 405)
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst Ag, Kastengrund, conventional breeding
- Age at study initiation: approx. 3 to 5 months
- Weight at study initiation: 3.2 to 3.7 kg
- Housing: single caged in fully conditioned rooms
- Diet: Altromin 2123 rabbit diet (Altromin GmbH, Lage/Lippe, Germany), ad libitum; hay, approx. 15 g/d
- Water: deionised, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 50 +/-20
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with physiological solution of sodium chloride (37 °C)
- Time after start of exposure: 24 h (and at every reading when discharge of the eyes occurred or sodium-fluorescein was used for scoring)

SCORING SYSTEM: according to OECD TG 405

TOOL USED TO ASSESS SCORE: at 48 and 72 h reading 1 drop of sodium-fluorescein (0.1%) added for scoring
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
- Conjunctival redness was observed in 3/3 animals at one hour after instillation of the test item (score (redness): 1) as well as in 2/3 animals at the 24 h reading. This effect was fully reversible by 48 hours after application.
- No effects on cornea, iris, or chemosis occurred (score 0 at every time point)
Other effects:
There was discharge observed in all animals one hour after instillation of the test material.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to eyes under these test conditions. Test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

Test material was subject to an acute eye irritation/corrosion test in 3 rabbits according to OECD TG 405. No corneal or iridial effects were observed. Chemosis was not found likewise. Conjunctival redness was observed in 3/3 animals at one hour after instillation of the test item (score (redness): 1) as well as in 2/3 animals at the 24 h reading. This effect was fully reversible by 48 hours after application. As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is not irritating to eyes and has not to be classified for eye irritation.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 28 JUL 1992 to 31 JUL 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: EPA-TSCA 40 CFR 798
Deviations:
no
Principles of method if other than guideline:
- test for acute irritation of the eye in rabbits (0.1 mL of the test item was instilled into the conjunctival sac of one eye of each rabbit (6 animals in total). The eyes remained unwashed. Ocular responses were assessed at 1 hour post dose and on days 1, 2 and 3.)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- 3 male /3 female animals tested
- Source: Ace animals
- Weight at study initiation: 2.4 to 2.9 kg
- Housing: 1/ cage in suspended
- Diet: Fresh purina rabbit chow (Diet #5321) was provided daily
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light):12 /12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
72 h (eyes remained unwashed)
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6 (3 males/3 females)
Details on study design:
SCORING SYSTEM: basically in accordance to OECD TG 405
- evaluation was performed 1, 24, 48, and 72 hours after application of the test item
TOOL USED TO ASSESS SCORE: The eyes of all rabbits were examined with sodium fluorescein after the 24 hour reading.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal: #1/#2/#3/#4/#6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 24-48-72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: redness
Irritant / corrosive response data:
- there were no corneal or iridial effects, as well as no chemosis visible at any time
- in 1/6 animals there was a conjunctival effect visible (score (redness):1) at the 24 hour reading. At any other time as well as in the remaining animals no conjunctival effects were observed.
Other effects:
For up to one hour after the instillation of the test item into one eye it remained in the conjunctiva in all animals as well as the area around the eyes were stained magenta for the whole duration of the test.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material 2, 9-Dichloroquinacridone is not irritating to eyes under these test conditions. Test material 2, 9-Dichloroquinacridone contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

Test material 2, 9-Dichloroquinacridone was subject to an acute eye irritation/corrosion test in 6 New Zealand white rabbits according to FDA guideline. The test item (0.1 mL) was instilled into the conjunctival sac of one eye of each rabbit and the eyes remained unwashed. Ocular responses were assessed at 1 hour post dose and on days 1, 2 and 3. Under these conditions no corneal or iridial effects were observed. Chemosis was not found likewise. Conjunctival redness was observed in 1/6 animals at 24 hours after instillation of the test item (score (redness): 1). This effect was fully reversible by 48 hours after application. As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material 2, 9 -Dichloroquinacridone is not irritating to eyes and has not to be classified for eye irritation.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).

4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13).
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal: #1/#2/#3/#4/#6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: redness
Irritant / corrosive response data:
- there were no corneal or iridial effects, as well as no chemosis visible at any time
- in 1/6 animals there was a conjunctival effect visible (score (redness):1) at the 24 hour reading. At any other time as well as in the remaining animals no conjunctival effects were observed.
Other effects:
For up to one hour after the instillation of the test item into one eye it remained in the conjunctiva in all animals as well as the area around the eyes were stained magenta for the whole duration of the test.
Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: other: CLP regulation
Conclusions:
The toxicity profile of Pigment Red 202 is assessed based on analogue approaches:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material 2, 9-Dichloroquinacridone is not irritating to eyes under these test conditions. Test material 2, 9-Dichloroquinacridone contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

Test material 2, 9-Dichloroquinacridone was subject to an acute eye irritation/corrosion test in 6 New Zealand white rabbits according to FDA guideline. The test item (0.1 mL) was instilled into the conjunctival sac of one eye of each rabbit and the eyes remained unwashed. Ocular responses were assessed at 1 hour post dose and on days 1, 2 and 3. Under these conditions no corneal or iridial effects were observed. Chemosis was not found likewise. Conjunctival redness was observed in 1/6 animals at 24 hours after instillation of the test item (score (redness): 1). This effect was fully reversible by 48 hours after application. As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material 2, 9 -Dichloroquinacridone is not irritating to eyes and has not to be classified for eye irritation.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).

4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13).
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
- Conjunctival redness was observed in 3/3 animals at one hour after instillation of the test item (score (redness): 1) as well as in 2/3 animals at the 24 h reading. This effect was fully reversible by 48 hours after application.
- No effects on cornea, iris, or chemosis occurred (score 0 at every time point)
Other effects:
There was discharge observed in all animals one hour after instillation of the test material.
Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: CLP regulation
Conclusions:
The toxicity profile of Pigment Red 202 is assessed based on analogue approaches:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to eyes under these test conditions. Test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

Test material was subject to an acute eye irritation/corrosion test in 3 rabbits according to OECD TG 405. No corneal or iridial effects were observed. Chemosis was not found likewise. Conjunctival redness was observed in 3/3 animals at one hour after instillation of the test item (score (redness): 1) as well as in 2/3 animals at the 24 h reading. This effect was fully reversible by 48 hours after application. As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is not irritating to eyes and has not to be classified for eye irritation.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).

4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13).
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: effects observed at 1 hour, but reversible by 24 hour observation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
The toxicity profile of Pigment Red 202 is assessed based on analogue approaches:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to eyes under these test conditions.
Executive summary:

A study according to OECD Guideline 405 and EU Method B.5 was performed to investigate the irritation potential to the rabbit eye.

One and 24 hours after treatment the conjunctivae of the animals showed definitely injected blood vessels up to a diffuse crimson red colour. Additionally, a very slight swelling and slight from substance coloured eye discharge were observed in one animal one hour after treatment. Fourty-eight hours after treatment all signs of irritation were reversible.

As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is not irritating to eyes and has not to be classified for eye irritation.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 22 OCT 1979 to 25 OCT 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guideline
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: FDA guideline (Federal Register 38, No. 187, 27.9.1973)
Deviations:
no
GLP compliance:
not specified
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: in house breeding (Hoe:HIMK(SPFWiga))
- Weight at study initiation: 1.5 to 2 kg
- Housing: single caged
- Diet: standard diet ERKA 8300 (Futtermittelwerk Robert Koch oHG, Hamm/Westf., Germany), ad libitum
- Water: ad libitum
Vehicle:
other: polyethylene glycol 400
Controls:
not required
Amount / concentration applied:
100 mg
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg test substance pasted with 3 drops of PEG 400
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological solution of sodium chloride
- Time after start of exposure: 24 h


SCORING SYSTEM: according to OECD TG 405


TOOL USED TO ASSESS SCORE: magnifier (at 48 and 72 h reading 1 drop of sodium-fluorescein (0.1%) added for scoring)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
, #2, #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
, #2, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Neither corneal nor iridial effects were observed at any time point during the test.
Conjunctival redness was observed in 6/6 animals at one and seven hours after instillation of the test item (score (redness): 1 or 2). This effect was fully reversible in 5/6 animals by 72 hours after application. In one animal this score ameliorated from 1 to 0 at the 48 hour reading, but then increased again to 1 at the 72 hour reading. Thus it cannot be stated as fully reversible in all animals.
Chemosis was visible in 2/6 animals at the one hour reading and in 1/6 animals at the 7 and 24 hour reading. This effect was fully reversible by 48 hours after application.
Other effects:
There was discharge observed in 5/6 animals one hour after instillation of the test material as well as in 2/6 animals at the seven hour reading.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
It is concluded that the test is not irritating to eyes under these test conditions and has not to be classified according to the classification criteria of Regulation (EC) No 1272/2008. No corneal or iridial effects were observed. Conjunctival redness was observed in 6/6 animals at one and seven hours after instillation of the test item (score (redness): 1 or 2) as well as in 5/6 animals at the 24 h reading. These effects were fully reversible by 72 hours after application in 5/6 animals. In one animal this score ameliorated from 1 to 0 at the 48 hour reading, but then increased again to 1 at the 72 hour reading. Thus it cannot be stated as fully reversible in this animal. Nevertheless we assume this observation as not relevant due to the fact that the score has been already diminished to 0. Additionally in all other treated animals the observed positive conjunctival reactions vanished until the 72 hour reading. Chemosis was visible in 2/6 animals at the one hour reading and still in 1/6 animals at the 7 hour and 24 hour reading. This effect was fully reversible by 48 hours after application. Test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

Test material was subject to an acute eye irritation/corrosion test in 6 rabbits according to FDA guidelines (similar to OECD TG 405). No corneal or iridial effects were observed until the end of the observation period (72 h). Conjunctival redness was observed in 6/6 animals at one and seven hours after instillation of the test item (score (redness): 1 or 2) as well as in 5/6 animals at the 24 h reading. These effects were fully reversible by 72 hours after application in 5/6 animals. In one animal this score ameliorated from 1 to 0 at the 48 hour reading, but then increased again to 1 at the 72 hour reading. Chemosis was visible in 2/6 animals at the one hour reading and still in 1/6 animals at the 7 hour and 24 hour reading. This effect was fully reversible by 48 hours after application.

As it can be plausibly assumed that the minimal redness observed in 1/6 animals after 72 hours would have been reversible, if the observation time would have been longer and because the mean values of the observed eye responses were below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is judged not to be irritating to eyes and has not to be classified for eye irritation.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).

4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13).
Reason / purpose for cross-reference:
read-across source
Number of animals or in vitro replicates:
6
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
, #2, #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
, #2, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Neither corneal nor iridial effects were observed at any time point during the test.
Conjunctival redness was observed in 6/6 animals at one and seven hours after instillation of the test item (score (redness): 1 or 2). This effect was fully reversible in 5/6 animals by 72 hours after application. In one animal this score ameliorated from 1 to 0 at the 48 hour reading, but then increased again to 1 at the 72 hour reading. Thus it cannot be stated as fully reversible in all animals.
Chemosis was visible in 2/6 animals at the one hour reading and in 1/6 animals at the 7 and 24 hour reading. This effect was fully reversible by 48 hours after application.
Other effects:
There was discharge observed in 5/6 animals one hour after instillation of the test material as well as in 2/6 animals at the seven hour reading.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
The toxicity potential was assessed based on analogue approach.
It is concluded that the test is not irritating to eyes under these test conditions and has not to be classified according to the classification criteria of Regulation (EC) No 1272/2008. No corneal or iridial effects were observed. Conjunctival redness was observed in 6/6 animals at one and seven hours after instillation of the test item (score (redness): 1 or 2) as well as in 5/6 animals at the 24 h reading. These effects were fully reversible by 72 hours after application in 5/6 animals. In one animal this score ameliorated from 1 to 0 at the 48 hour reading, but then increased again to 1 at the 72 hour reading. Thus it cannot be stated as fully reversible in this animal. Nevertheless we assume this observation as not relevant due to the fact that the score has been already diminished to 0. Additionally in all other treated animals the observed positive conjunctival reactions vanished until the 72 hour reading. Chemosis was visible in 2/6 animals at the one hour reading and still in 1/6 animals at the 7 hour and 24 hour reading. This effect was fully reversible by 48 hours after application. Test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

Test material was subject to an acute eye irritation/corrosion test in 6 rabbits according to FDA guidelines (similar to OECD TG 405). No corneal or iridial effects were observed until the end of the observation period (72 h). Conjunctival redness was observed in 6/6 animals at one and seven hours after instillation of the test item (score (redness): 1 or 2) as well as in 5/6 animals at the 24 h reading. These effects were fully reversible by 72 hours after application in 5/6 animals. In one animal this score ameliorated from 1 to 0 at the 48 hour reading, but then increased again to 1 at the 72 hour reading. Chemosis was visible in 2/6 animals at the one hour reading and still in 1/6 animals at the 7 hour and 24 hour reading. This effect was fully reversible by 48 hours after application.

As it can be plausibly assumed that the minimal redness observed in 1/6 animals after 72 hours would have been reversible, if the observation time would have been longer and because the mean values of the observed eye responses were below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is judged not to be irritating to eyes and has not to be classified for eye irritation.

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

No classification

The test material was not irritant to skin and eyes in in vivo assays in rabbits.