Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin irritation (rabbit): not irritating

Eye irritation (rabbit): 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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substances Act
Principles of method if other than guideline:
- Principle of test: Draize Test
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratory Animals, Inc., Denver, Pennsylvania, USA
Type of coverage:
occlusive
Preparation of test site:
other: clipped intact or abraded
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: 50%

Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 (per intact and abraded skin)
Details on study design:
TEST SITE
- Area of exposure: On the back, (intact and abraded skin sites)
- Coverage square: One inch
- Type of wrap: Gauze patches

OBSERVATION TIME POINTS: 24 and 72 hours

SCORING SYSTEM:
- Method of calculation: J.H. Draize, Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics, Assoc. Food and Drug Officials of the U.S., Austin, Texas, 1959

Evaluation of Skin Reactions

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

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 1.0 mm.): 3
Severe edema (raised more than 1.0 mm. extending beyond the area of exposure): 4

The values-for erythema and eschar formation at 24 hours-and 72 hours for intact skin animals will be added to the values on abraded skin animals at 24 and 72 hours (four values). Similarly, the values for edema formation at 24 hours and at 72 hours for the intact and abraded skin animals will be added (four values). The primary irritant score is the total of the eight values divided by four. A primary irritant is one which results in a score of five or more as tested by this method.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
8

The skin irritation study was conducted according to the Federal Hazardous Substances Act.

0.5 mL of the test substance (formulation of 50% in water) was administered to six rabbits on the intact and abraded skin for 24 hours. At 24 and 72 hours observations were made, graded, and scored according to the system of J. H. Draize.

The primary irritation score for the test substancel was 0.0; therefore, the test substance is not a primary irritant under the conditions of this test.

Interpretation of results:
other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: US Federal Hazardous Substances Act
Version / remarks:
not further specified in the report, but equivalent to method published in US Federal Register 38, No 187 of September 27, 1979
Principles of method if other than guideline:
- Principle of test: Draize Test
GLP compliance:
no
Specific details on test material used for the study:
Two compounds of the test substance with a formulation of 70% in castor oil were tested
BCL 1579B (Biju BO)
BCL 1579D (Biju MO)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratory Animals, Inc., Denver, Pennsylvania, USA
Type of coverage:
occlusive
Preparation of test site:
other: clipped intact or abraded
Vehicle:
other: castor oil
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: 70%

Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 (per intact and abraded skin)
Details on study design:
TEST SITE
- Area of exposure: On the back, (intact and abraded skin sites)
- Coverage square: One inch
- Type of wrap: Gauze patches

OBSERVATION TIME POINTS: 24 and 72 hours

SCORING SYSTEM:
- Method of calculation: J.H. Draize, Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics, Assoc. Food and Drug Officials of the U.S., Austin, Texas, 1959

Evaluation of Skin Reactions

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

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 1.0 mm.): 3
Severe edema (raised more than 1.0 mm. extending beyond the area of exposure): 4

The values-for erythema and eschar formation at 24 hours-and 72 hours for intact skin animals will be added to the values on abraded skin animals at 24 and 72 hours (four values). Similarly, the values for edema formation at 24 hours and at 72 hours for the intact and abraded skin animals will be added (four values). The primary irritant score is the total of the eight values divided by four. A primary irritant is one which results in a score of five or more as tested by this method.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
1.1
Max. score:
4
Reversibility:
other: not fully reversible within 72 h in 4/6 animals, fully reversibel within: 2/6 animals
Remarks on result:
other: compound BCL 1579B
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 72 h in all animals
Remarks on result:
other: compound BCL 1579B
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
0.8
Max. score:
4
Reversibility:
fully reversible within: 72 h in all animals
Remarks on result:
other: compound BCL 1579D
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 72 h in all animals
Remarks on result:
other: compound BCL 1579D
Irritant / corrosive response data:
Dermal irritation consisted of slight to moderate erythema and slight edema at 24 and 72 hours for intact and abraded skin sites receiving either compounds. (For further details see tables below)

Table 1: Results of skin irritation study (BCL 1579B)

Observation time

Rabbit no.

1

2

3

4

5

6

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

24 h

2

1

2

1

2

1

0

0

0

0

2

1

48 h

No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)

72 h

1

0

1

0

1

0

0

0

0

0

1

0

Table 2:. Calculation of mean scores (BCL 1579B)

Rabbit no.

1

2

3

4

5

6

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Mean value

24 + 48 + 72 h*

1.7

0.7

1.7

0.7

1.7

0.7

0.0

0.0

0.0

0.0

1.7

0.7

*No 48 h data are available: for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h

Table 3: Results of skin irritation study (BCL 1579D)

Observation time

Rabbit no.

1

2

3

4

5

6

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

24 h

1

0

1

0

2

1

1

0

1

0

1

0

48 h

No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)

72 h

0

0

0

0

0

0

0

0

0

0

0

0

Table 4:. Calculation of mean scores (BCL 1579D)

Rabbit no.

1

2

3

4

5

6

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Mean value

24 + 48 + 72 h*

0.7

0.0

0.7

0.0

1.3

0.7

0.7

0.0

0.7

0.0

0.7

0.0

*No 48 h data are available: for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h

Table 5: Results of skin irritation study (BCL 1579B) (incl abraded skin data)

BCL 1579B

rabbit no skin Erythema 24h Erythema 72h Edema 24h Edema 72h
176 abraded 0 0 0 0
177 abraded 1 0 0 0
178 abraded 1 0 0 0
179 abraded 1 0 0 0
180 abraded 2 0 1 0
181 abraded 2 0 0 0
Mean 1.1 0 0.1 0
182 intact 2 1 1 0
183 intact 2 1 1 0
184 intact 2 1 1 0
185 intact 0 0 0 0
186 intact 0 0 0 0
187 intact 2 1 1 0
Mean 1.3 0.7 0.7 0

Primary Irritation Score (sum of means/4) = 0.97 (max score=8)

Table 6: Results of skin irritation study (BCL 1579D) (incl abraded skin data)

BCL 1579D
rabbit no skin Erythema 24h Erythema 72h Edema 24h Edema 72h
176 abraded 1 0 0 0
177 abraded 1 0 0 0
178 abraded 1 0 0 0
179 abraded 1 0 0 0
180 abraded 2 0 1 0
181 abraded 1 0 0 0
Mean 1.1 0 0.1 0
182 intact 1 0 0 0
183 intact 1 0 0 0
184 intact 2 0 1 0
185 intact 1 0 0 0
186 intact 1 0 0 0
187 intact 1 0 0 0
Mean 1.1 0 0.1 0

Primary Irritation score (sum of means/4) = 0.60 (max score = 8)

Summary

The skin irritation study was conducted according to the Federal Hazardous Substances Act. Two test compounds with a formulation of 70% in castor oil were tested.

The test substance was administered to six rabbits on the intact and abraded skin for 24 hours.

Scoring according to the Draize method was conducted after 24 and 72 hours.

The primary irritation score for compound 1 was determined to be 0.97 and for compound 2 it was determined to be 0.6, therefore, neither compound is a primary irritant under the conditions of this test.

Interpretation of results:
other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified
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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
- Principle of test: Draize method
- Parameters analysed: Irritation, corneal damage
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratory Animals, Inc., Denver, Pennsylvania
- Weight at study initiation: 2,8 - 3 kg

Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 50%

Duration of treatment / exposure:
2 seconds, 4 seconds and 7 days (not washed)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 per group
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Yes, for 2 groups with lukewarm tap water
- Time after start of exposure: Irrigated 2 seconds and 4 seconds postinstillation

SCORING SYSTEM: Draize method but not described in detail in the report

TOOL USED TO ASSESS SCORE: Fluorescein for evidence of corneal damage
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals; Nonirrigated
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 animals; Irrigated 2 seconds postinstillation
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Remarks:
3 animals: Irrigated 4 seconds postinstillation
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation

In the OECD guideline 405 similar eye irritation test, the test substance (formulation of 50% in water) was tested for eye irritation in rabbits.

0.1 mL of the test substance was administrated to the left eye of 9 rabbits. The right eye served as control.

There were three groups with each three rabbits. The treated eyes 1) were not washed, 2) washed two seconds postinstillation, or 3) washed four seconds postinstillation with approximately 25 mL of lukewarm tap water.

Observations for eye injury and irritation were made at 24, 48, and 72 hours and at four and seven days and graded and scored according to the system of J. H. Draize. There were no signs of eye irritation in any animal throughout the entire seven day test period. Terminal fluorescein examination confirmed the absence of corneal damages in all treated eyes.

Interpretation of results:
other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
- Principle of test: Draize method
GLP compliance:
no
Specific details on test material used for the study:
Two compounds containing the test substance in a formulation of 70% in castor oil were tested:
BCL 1579B
BCL 1579D
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratory Animals, Inc., Denver, Pennsylvania
- Weight at study initiation: 2,3 kg - 3,5 kg
Vehicle:
other: castor oil
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 70%

Duration of treatment / exposure:
2 seconds, 4 seconds, 7 days (not washed)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 animals for each group
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Yes
- Time after start of exposure: 2 and 4 seconds

SCORING SYSTEM: Draize method but not described in detail in the report

TOOL USED TO ASSESS SCORE: Fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals; Non-irrigated
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals; 2 sec. postinstillation
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals, 4 sec. postinstillation
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The results refer to both tested compounds.
There was no evidence of eye irritation in any of the test animals throughout the seven day test period.

In the OECD guideline 405 similar eye irritation test, two compounds containing the test substance (as formulation of 70% in castor oil) were tested for eye irritation in rabbits.

0.1 mL of the test substance was administrated to the left eye of 9 rabbits. The right eye served as control.

There were three groups with each three rabbits. The treated eyes 1) were not washed, 2) washed two seconds postinstillation, or 3) washed four seconds postinstillation with approximately 25 mL of lukewarm tap water.

Observations for eye injury and irritation were made at 24, 48, and 72 hours and at four and seven days and graded and scored according to the system of J. H. Draize. There were no signs of eye irritation or corneal damage in any animal throughout the entire seven day test period. Terminal fluorescein examination confirmed the absence of corneal damage in all treated eyes.

Furthermore, the weight of the animals was also observed at the start and end of the study. No significant effects were observed.

Interpretation of results:
other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
02 Oct 2012
Principles of method if other than guideline:
- Principle of test: the tes item was applied to the rabbit eye to analyse irritation potential of the test item by the Draize method.
- Short description of test conditions: Left eye of rabbits was instilled with test material. 3 eyes were washed 2 seconds, further 3 eyes 4 seconds after application of test item and the other 3 eyes were not washed at all. The right eye served as control. Examination of the eye was performed before instillation and at 24, 48 and 72 h and at day 4 and 7 after last treatment.
- Parameters analysed / observed: cornea opacity, iris, conjunctivae (redness, chemosis, discharge)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.9 - 3.1 kg
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:
2 and 4 seconds and 7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 per group
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with 20 mL of tap water, 3 animals without washing
- Time after start of exposure: 2 and 4 sec (3 animals each)

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals (without washing)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals (without washing)
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals (without washing)
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h in all animals
Remarks on result:
other: All 3 animals showed the same reaction: score 1 at 24 h, score 0 at 48 and 72 h.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals (without washing)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Slight redness was noted in 5/9 animals at 24 h (with and without washing), which was reversible.
Interpretation of results:
other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Irritation

There are in vivo data available regarding skin and eye irritation/ corrosion for Bismuth chloride oxide (CAS 7787-59-9) in order to fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VIII, 8.1 and 8.2.

 

Skin Irritation

CAS 7787-59-9

A skin irritation study was performed with the test material (50% formulation) according to Federal Hazardous Substances Act (reference 7.3.1-1). The clipped skin of the back of in 6 New Zealand White rabbits (per dose) was exposed to 0.5 mL test material for 24 h under occlusive conditions. The rabbits were observed for 3 days. Skin reactions were assessed using the Draize scoring system 24 and 72 h after patch removal. No skin evaluation was performed 48 h after patch removal. The mean scores for erythema and eschar formation at 24 and 72 h were calculated by adding the values on intact skin to the values on abraded skin animals (four values). The same was done for the values of edema formation. The primary irritation score is the total of the eight values divided by four. Therefore, the mean primary dermal irritation index (for 24 and 72 h) was calculated to be 0.0, indicating that the test material is not irritating to the skin.

 

Another skin irritation study was performed with two compounds (1: Biju BO and 2: Biju MO) of the test material (both 70% formulations) according to Federal Hazardous Substances Act (reference 7.3.1-2). The clipped skin of in 6 New Zealand White rabbits (per dose) was exposed to 0.5 mL test material for 24 hours under occlusive conditions. The rabbits were observed for 3 days. Skin reactions were assessed using the Draize scoring system 24 and 72 h after patch removal. No skin evaluation was performed 48 h after patch removal. As no experimental data was available for the 48 h time point, the 48 h values were assumed to be the same as those at 24 h (worst case assumption) for the calculation of the mean scores of erythema and edema. The exposure period of 24 h with compound 1 caused very slight to well defined erythema, which was reversible within 72 h in 2/6 animals and not fully reversible in die other 4 animals with intact skin. In addition very slight edema was observed which was reversible within 72 h in all animals. The exposure period of 24 h with compound 2 caused very slight to well defined erythema and very slight edema, which were fully reversible within 72 h in all animals with intact skin. The mean erythema and edema scores of both compounds are below the thresholds for irritation indicating that the test material is not irritating to the skin.

 

Further supporting information is available based on the results of a dermal study on repeated dose toxicity, performed with the test material (reference 7.5.3-3). The test material (25 % in distilled water) was applied daily for 90 days onto the abraded skin of 10 female albino rabbits at concentrations of 2 mL/kg bw or 0.2 mL/kg bw. After this period the animals were sacrificed and amongst others the skin was examined macroscopically and microscopically, showing no abnormalities. But it was observed that the skin of the animals became pliable and loose after 1 week, which was more pronounced in the group with the higher dose (2 mL/kg bw).

 

Eye irritation

CAS 7787-59-9

An acute eye irritation study was performed with the test substance (50% formulation) similar to OECD guideline 405 (reference 7.3.2-1). 1 group of 3 New Zealand White rabbits was treated with 0.1 mL of the test substance. The test substance was applied into the conjunctival sac of one eye per animal while the untreated eye served as control. The eyes of the animals were not washed out. Two other groups of rabbits were treated in the same way, except that the eyes were washed out after 2 and 4 seconds, respectively. The untreated eye served as a control. The animals were observed for 7 days and scoring was performed 24, 48 and 72 h after application. No effects on iris or cornea were observed, leading to a mean cornea opacity score of 0.0 in all 3 groups (animals without test substance removal, animals with removal of test substance after 2 and 4 sec after treatment). Based on these results the test material is not regarded as eye irritant.

 

Another acute eye irritation study with two compounds (1: Biju BO and 2: Biju MO) containing the test material (both 70% formulations) was performed similar to OECD guideline 405 (reference 7.3.2-2).1 group of 3 New Zealand White rabbits was treated with 0.1 mL of the test material. The test material was applied into the conjunctival sac of one eye per animal while the untreated eye served as control. The eyes of the animals were not washed out. Two other groups of rabbits were treated in the same way, except that the eyes were washed out after 2 and 4 seconds, respectively.. The untreated eye served as a control. The animals were observed for 7 days and scoring was performed 24, 48 and 72 h after application. No effects on iris or cornea were observed, leading to a mean cornea opacity score of 0.0 in all 3 groups (animals without test substance removal, animals with removal of test material after 2 and 4 sec after treatment). Based on these results the test material is not regarded as eye irritant.

 

Another eye irritation study, performed with the test material according to a protocol which is similar to OECD guideline 405 (reference 7.3.2.-3). 1 group of 3 New Zealand White rabbits was treated with 0.1 mL of the test material. The test material was applied into the conjunctival sac of one eye per animal while the untreated eye served as control. The eyes of the animals were not washed out. Two other groups of rabbits were treated in the same way, except that the eyes were washed out after 2 and 4 seconds, respectively. The animals were observed for 7 days and scoring was performed 24, 48 and 72 h after application. 24 h after test material application slight conjunctival redness was observed in 5/9 animals (score 1), which was reversible within 48 or latest 72 h. Based on these results the test material is not regarded as eye irritant.

 

Further information is available based on an acute eye irritation study performed with a 1% solution of the test substance only (reference 7.3.2.-4). One eye of the 5 rabbits was exposed to 0.1 mL of the diluted test substance and scored for eye reactions. The untreated eye served as control. The animals were observed for 7 days and scoring was performed every day. No effects on iris and cornea were observed leading to a mean cornea opacity/iris/conjunctivae and chemosis score of 0.0 in all animals.

Justification for classification or non-classification

The available data on skin and eye irritation/ corrosion with Bismuth chloride oxide (CAS 7787-59-9) do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and are therefore conclusive but not sufficient for classification.