Registration Dossier
Registration Dossier
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EC number: 203-445-0 | CAS number: 106-94-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- The information was generated in 1978. Invitro/ ex-vivo tests were not available.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Hazardous Substances Act Regulations, Federal Register vol. 33, section 1500.41
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 1-bromopropane
- EC Number:
- 203-445-0
- EC Name:
- 1-bromopropane
- Cas Number:
- 106-94-5
- Molecular formula:
- CH3CH2CH2Br
- IUPAC Name:
- 1-bromopropane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: A supplier local to the testing laboratory
- Age at study initiation: NDA
- Weight at study initiation: 2 - 3 kg
- Housing: NDA
- Diet (e.g. ad libitum): NDA
- Water (e.g. ad libitum): NDA
- Acclimation period: At least 3 weeks in laboratory conditions.
ENVIRONMENTAL CONDITIONS
NDA
IN-LIFE DATES: NDA
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: 3 animals with a clipped patch, 3 with an abraded patch
- 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:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 rabbits of unspecified sex.
- Details on study design:
- TEST SITE
- Area of exposure: less than one square inch.
- % coverage: NDA
- Type of wrap if used: one square inch sugical gauze. The trunk of the animal was wrapped in an impervious material in place for 24 hours.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing stated.
- Time after start of exposure: N/A
SCORING SYSTEM: Erythema, edema and primary irritation score.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.17
- Max. score:
- 1
- Reversibility:
- no data
- Remarks on result:
- other: Edema only observed for one animal with abraded skin. No effects seen on animals with clipped skin.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- no data
- Remarks on result:
- other: Edema only observed for one animal with abraded skin. No effects seen on animals with clipped skin.
Any other information on results incl. tables
Primary irritation score = 0.25
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Edema was observed in one out of the six animals tested. No eschar formation was observed. Propylbromide is considered to be a nonirritant.
- Executive summary:
An acute dermal irritation study was performed on 1-bromopropane using 6 albino rabbits with weights from 2 - 3 kg (24 hour exposure, tests sites both intact and abraded) representing a worst case scenario for assessing irritation.
Edema was observed in one out of the six animals tested. No eschar formation was observed. Propylbromide is considered as a nonirritant.
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