Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-623-8 | CAS number: 108-86-1
- 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
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- 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): 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:
- key study
- Study period:
- Oct - Nov 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Please refer to analogue justification provided in IUCLID section 13
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 28 Jul 2015
- Deviations:
- yes
- Remarks:
- no initial test was performed
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: HC:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Weight at study initiation: about 3000 g
- Housing: individual housing under standardized coditions
- Diet: Ssniff K (Versuchstierdiäten GmbH, Soest, Germany), ad libitum
- Water: Tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: 100% - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
Reading time points: 1, 24, 48 and 72 h and 6 days - Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 x 6 cm on the dorsal area of the trunk
- Type of wrap if used: The treated skin was covered with an elastic and air permeable bandage
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed with water
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48 and 72 h and 6 days
SCORING SYSTEM:
- Method of calculation: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- All animals showed moderate erythema and slight edema on the application sites that were fully reversible within 6 days.
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- CLP: Skin Irrit 2, H315
Reference
Table 1: Results of skin irritation
Observation time | Rabbit no. | |||||
1 | 2 | 3 | ||||
Erythema | Edema | Erythema | Edema | Erythema | Edema | |
1 h | 3 | 0 | 3 | 0 | 2 | 0 |
24 h | 3 | 1 | 3 | 1 | 2 | 1 |
48 h | 3 | 1 | 3 | 1 | 2 | 1 |
72 h | 3 | 1 | 3 | 1 | 2 | 1 |
Mean value 24 + 48 + 72 h | 3,00 | 1,00 | 3,00 | 1,00 | 2,00 | 1,00 |
6 d | 0 | 0 | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Please refer to the analogue approach justification document provided in section 13
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 02 Oct 2012
- Deviations:
- yes
- Remarks:
- no topical anesthetics and systemic analgesics were used; no initial test was performed
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: HC:NZW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Weight at study initiation: about 3000 g
- Housing: individual housing under standardized coditions
- Diet: Ssniff K (Versuchstierdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 100%
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 21 days
Reading time points: 1, 24, 48 and 72 h and 7 days - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the treated eye was rinsed with NaCl solution
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- 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:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- All animals showed mild to moderate (graded with scores of 1 - 2) conjunctival redness and swelling after test substance instillation. In one animal slight opacity of the cornea was observed at the 1 and 24 h reading time points. All effects were fully reversible latest within 7 days. No further substance-related 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
Reference
Table 1: Individual scores
Rabbit # | Time [h] | conjunctivae | iris | cornea | |
redness | swelling | ||||
1 | 1 | 1 | 1 | 0 | 0 |
24 | 1 | 1 | 0 | 0 | |
48 | 1 | 0 | 0 | 0 | |
72 | 1 | 0 | 0 | 0 | |
average | 1.0 | 0.3 | 0.0 | 0.0 | |
2 | 1 | 2 | 1 | 0 | 1 |
24 | 2 | 1 | 0 | 1 | |
48 | 1 | 1 | 0 | 0 | |
72 | 0 | 0 | 0 | 0 | |
average | 1.0 | 0.7 | 0.0 | 0.3 | |
3 | 1 | 1 | 1 | 0 | 0 |
24 | 1 | 1 | 0 | 0 | |
48 | 1 | 0 | 0 | 0 | |
72 | 0 | 0 | 0 | 0 | |
average | 0.7 | 0.3 | 0.0 | 0.0 | |
Time [h] | conjunctivae | iris | cornea | ||
redness | swelling | ||||
average score |
1 | 1.33 | 1.00 | 0.00 | 0.33 |
24 | 1.33 | 1.00 | 0.00 | 0.33 | |
48 | 1.00 | 0.33 | 0.00 | 0.00 | |
72 | 0.33 | 0.00 | 0.00 | 0.00 | |
24+48+72 | 0.89 | 0.44 | 0.00 | 0.11 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Irritation
There are no data available on skin and eye irritating properties of bromobenzene (CAS 108-86-1). Thus, read-across from an appropriate substance is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. in order to fulfil the standard information requirements defined in Regulation (EC) No 1907/2006, Annex VII, 8.1 and 8.2. Structural similarities and comparable toxicokinetic properties of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).
Skin irritation
CAS 108 -90 -7
The skin irritancy potential of chlorobenzene was determined in a skin irritation study performed similar to OECD 404 (reference 7.3.1-1). The test substance was topically applied to the shaved skin of three rabbits (NZW) for 4 h. Local reactions were scored at 1, 24, 48 and 72 h and 6 days after substance application. All animals showed moderate erythema and slight edema on the application sites (mean erythema scores of 3, 3 and 2 for the 3 animals over 24, 48 and 72 h; mean edema scores of 1 for all 3 animals over 24, 48 and 72 h) that were fully reversible within 6 days. Based on the results of the conducted study, chlorobenzene exhibits irritating properties towards the skin.
In conclusion, based on the analogue approach, bromobenzene is considered as skin irritant and meets the classification criteria for skin irritation, category 2 according to Regulation (EC) 1272/2008.
Eye irritation
CAS 108 -90 -7
To evaluate the irritation potential towards the eyes, 0.1 mL chlorobenzene (undiluted) was instilled into the eyes of 3 white rabbits (NZW) (reference 7.3.2-1). 24 hrs after test substance instillation, the eyes were rinsed with physiological saline solution. The eyes were observed 1, 24, 48, 72 and 168 h after treatment. All animals showed mild to moderate conjunctival redness (graded with scores of 1 - 2) and swelling (graded with score 0 - 1) resulting in mean scores of 1, 1, and 0.7 for conjunctivae and 0.3, 0.7 and 0.3 for chemosisfor all 3 animals over 24, 48 and 72 h, respectively. In one animal slight opacity of the cornea was observed after 1 and 24 h, resulting in a mean score of 0.3 over 24, 48 and 72 h. All effects were fully reversible latest within 7 days. Based on the results of the conducted study, chlorobenzene is considered as not irritating to the eyes.
In conclusion, based on the analogue approach, bromobenzene is not considered to exhibit eye irritating properties.
Justification for classification or non-classification
Based on the analogue approach, the available data on skin irritation meets the criteria for classification as Skin Irrit. Cat. 2 (H315) according to Regulation (EC) 1272/2008.
Based on the analogue approach, the data on eye irritation does not meet the classification criteria for eye irritation according to Regulation (EC) 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.