Registration Dossier
Registration Dossier
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EC number: 240-032-4 | CAS number: 15894-70-9
Endpoint summary
Administrative data
Description of key information
HMBDA is of low acute toxicity in mammals by both the oral and dermal routes.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Zeneca
- Age at study initiation: young adults
- Weight at study initiation: male=303-329g female=208-236g
- Fasting period before study: No
- Housing: Suspended cages (32.5cm x 37.5cm x 23cm) stainless steel
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 °C
- Humidity (%): 40-70%
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- other: hydroxypropylmethylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200mg/ml
- Amount of vehicle (if gavage): 10ml/kg - Doses:
- 2000mg/kg
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days post dose
- Frequency of observations and weighing: daily observations, weighing days -1, 1, 2, 3, 4, 8, 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, post mortem examination - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- None of the animals died
- Clinical signs:
- other: There were no signs of toxicity in any animal at any time during the study
- Gross pathology:
- No treatment related macroscopic findings
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 was >2000 mg/kg to rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Sufficient to meet data requirements. The study is Klimisch 1.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- An acute inhalation toxicity study is scientifically unjustified and is not in the interests of animal welfare. Acute studies are available by the oral and dermal routes.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Zeneca
- Age at study initiation: Young adults
- Weight at study initiation: male=234-254g female=188-200g
- Housing: suspended cages (32.5cm x 37.5cm x 23cm) stainless steel
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 40-70%
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Approximately 4cm x 6cm
- Type of wrap if used: gauze patch covered by plastic film and held in position using adhesive bandage and PVC tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton wool soaked in clean warm water
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): amount calculated according to weight and adjusted for water content to give dose of 2000mg/kg
- For solids, paste formed: yes, by addition of 0.3-0.4ml water - Duration of exposure:
- 24h
- Doses:
- 2000mg/kg
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: daily observations, weighing days 1, 3, 5, 8, 15
- Other examinations performed: clinical signs, body weight,post mortem examination - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- None of the animals died
- Clinical signs:
- other: There were no signs of toxicity in any animal at any time during the study. Signs of slight skin irritation (e.g. erythema, odema, scabbing) were seen in four males and two females, but had completely regressed by day 8.
- Gross pathology:
- No treatment related macroscopic findings
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 was >2000 mg/kg to rats
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Sufficient to meet data requirements. The study is Klimisch 1.
Additional information
HMBDA is of low acute toxicity in mammals by both the oral and dermal routes.The acute oral LD50 is > 2000 mg/kg while the acute dermal LD50 is > 2000 mg/kg. A low acute oral toxicity result (LD50 > 5000 mg/kg) was also reported in an additional, unreliable acute oral study. Testing by the inhalation route is not scientifically justified.
Justification for selection of acute toxicity – oral endpoint
Two acute oral studies are available. The selected study has the higher Klimisch score.
Justification for selection of acute toxicity – dermal endpoint
Only one study available.
Justification for classification or non-classification
Given the available LD50 values, HMBDA does not meet the criteria for classification for acute toxicity by either the oral or dermal routes.
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