Registration Dossier
Registration Dossier
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EC number: 203-691-9 | CAS number: 109-65-9
Endpoint summary
Administrative data
Description of key information
Skin irritation/corrosion
Butyl bromide is considered as a moderate-irritant. H315: Causes skin irritation.
Eye Irritation
MINIMAL IRRITANT to the rabbit eye. Does not meet classification criteria.
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:
- 28 June 2002- 30 July 2002
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Commision Directive 92/69/EEC
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: A supplier local to the testing laboratory
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2 - 3.5 kg
- Housing: the animals were individually housed in suspended metal cages
- Diet : certified rabbit diet (code 5322), free access
- Water :certified rabbit diet (code 5322), free access
- Acclimation period: At least 5 days in laboratory conditions.
ENVIRONMENTAL CONDITIONS
-Temperature: (°C) 17-23 ºC
- Humidity (%): 30-70 %
- Air changes (per hr): at least 15 changes per hr.
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: NDA - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): N/A
VEHICLE
No vehicle used - Duration of treatment / exposure:
- One patch was removed at 3 time points: 3 minutes, 1 hour and 4 hours.
Two additional patches were removed after 4 hours. - Observation period:
- 1 hr, 24, 48 and 72 hrs following removal.
- Number of animals:
- 3 animals.
- Details on study design:
- TEST SITE
- Area of exposure: NDA
- % coverage: NDA
- Type of wrap if used: sugical adhesive tape. The trunk of the animal was wrapped in an elasticated corset.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): removal by gentle swabbing with cotton wool soaked in 74% Industrial Methylated Spirits.
- Time after start of exposure: N/A
SCORING SYSTEM: Erythema/eschar and oedema. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a primary index of 4.2 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme.
- Executive summary:
The test material met the criteria for classification as irritant according to EU labelling Regulation (EC) No 1272/2008. H315: Causes skin irritation is applicable.
Reference
Primary Irritation Index (S/6)= 25/6= 4.2
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:
- 2002
- Reliability:
- 1 (reliable without restriction)
- 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 (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: A local supplier to the testing laboratory
- Age at study initiation: 20-20 weeks old
- Weight at study initiation: 2- 3.5 kg
- Housing: in suspended metal cages
- Diet :Certified rabbit diet code 5322
- Water: Free access to mains drinking water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
Room temperature: 17-23oc
Relative humidity: 30-70%
air exchange rate: 15 changes per hour, 12 hr light and 12 hr darkness
IN-LIFE DATES: NDA - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Left eye served as negative control
- Amount / concentration applied:
- 0.1 ml of test material
- Duration of treatment / exposure:
- The lids were gently held together for 1 second before releasing the rabbit. The eyes were not washed following treatment.
- Observation period (in vivo):
- The eyes were examined and grade of ocular reaction recorded at 1, 24, 48, 72 hrs with the aid of a standard ophthalmoscope to observe any corneal lesions and the degree of irritation recorded.
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not performed.
- Time after start of exposure: N/A
SCORING SYSTEM:
Grading of eye irritation was done using the numerical data obtained a system described by Kay J H and Calandra J C, J. Soc. Cosmet. Chem., 1962 13 281-289
TOOL USED TO ASSESS SCORE: standard ophthalmoscope - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 10
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 48 and 72 hrs
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 6
- Max. score:
- 10
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 48 and 72 hrs
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 10
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 48 and 72 hrs
- Score:
- 0
- Max. score:
- 10
- Irritant / corrosive response data:
- The test material produced a maximum group mean score of 9.3 and was classified as a MINIMAL IRRITANT to the rabbit eye according to a modified
Kay and Calandra classification system. - Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material did not meet the criteria for classification as irritant according to EU labelling Regulation (EC) No 1272/2008.
- Executive summary:
The test material produced a maximum group mean score of 9.3 and was classified as a MINIMAL IRRITANT to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not meet the criteria for classification as irritant according to EU labelling Regulation (EC) No 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion
An acute dermal irritation study was performed on Butyl bromide using 3 albino rabbits. Edema was observed in all animals tested. Eschar formation was observed in all 3 animals. Butyl bromide is considered as a moderate-irritant.
Eye Irritation
An acute eye irritation study was performed on 3 rabbits. The test material produced a maximum group mean score of 9.3 and was classified as a
MINIMAL IRRITANT to the rabbit eye according to a modified Kay and Calandra classification system.
Justification for selection of skin irritation / corrosion endpoint:
Available study reliability 1.
Justification for selection of eye irritation endpoint:
Available study reliability 1.
Effects on skin irritation/corrosion: moderately irritating
Justification for classification or non-classification
Skin irritation/corrosion
Butyl bromide is considered as a moderate-irritant.H315: Causes skin irritation.
Eye Irritation
The test material did not meet the criteria for classification as irritant according to EU labelling Regulation (EC) No 1272/2008.
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