Registration Dossier
Registration Dossier
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EC number: 240-032-4 | CAS number: 15894-70-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Conventional Animal Breeding Unit
- Age at study initiation: Young adult
- Weight at study initiation: 3285-3684g
- Housing: Individual aluminium sheet cages (65.2 x 68.9 x 45.7 cm)
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-19°C
- Humidity (%): 30-70
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500mg in approximately 0.5ml water
-Application site size: 2.5 x 2.5 cm - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5cm
- Type of wrap if used: surgical gauze secured by 2 crossed strips of surgical tape, covered with impermeable rubber sheeting secured with adhesive impermeable polyethylene tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cleansed using cleam swabs of absorbent cotton wool soaked in clean warm water and gently dried with clean tissue paper
- Time after start of exposure: 4h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritant / corrosive response data:
- Very slight erythema (grade 1) was observed in 2 animals, shortly after decontamination which had completely recovered after 24 hours. There were no other signs of irritation during the study.
- Other effects:
- None observed
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- HMBDA was not irritating to rabbit skin
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