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EC number: 232-122-7 | CAS number: 7787-59-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
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- Endpoint summary
- Stability
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- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
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
- 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
- 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)
- Interpretation of results:
- other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
Referenceopen allclose all
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.
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- 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. - 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
Referenceopen allclose all
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.
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.
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.
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