Registration Dossier
Registration Dossier
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EC number: 205-760-9 | CAS number: 150-46-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was not conducted according to guideline/s and GLP but the report contains sufficient data to permit a meaningful evaluation of study results. Though the study was not conducted in accordance to GLP, the report carries a Quality assurance inspection note
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Primary skin irritation study conducted using three male and three female rabbits. From this group of randomly selected animals, three rabbits were assigned to an intact group and three rabbits were assigned to an abraded group
- GLP compliance:
- no
Test material
- Reference substance name:
- Trimethyl borate
- EC Number:
- 204-468-9
- EC Name:
- Trimethyl borate
- Cas Number:
- 121-43-7
- Molecular formula:
- C3H9BO3
- IUPAC Name:
- trimethyl borate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Name of test material (as cited in study report): Trimethyl borate- Physical state: liquid
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Langshaw farms, Augusta, Michigan- Housing: Individually housed in hanging wire-mesh cage - Diet (e.g. ad libitum): Purina Certified Rabbit Chow- Water (e.g. ad libitum): ad libitum- Acclimation period: 7 daysENVIRONMENTAL CONDITIONS- Temperature (°F): 67-82- Humidity (%): 37- Photoperiod (hrs dark / hrs light):12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Intact skin and Abraded skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.5ml/test site
- Duration of treatment / exposure:
- 24 h
- Observation period:
72 h- Number of animals:
- 6 rabbits (3 male and 3 female)
- Details on study design:
- TEST SITE- Area of exposure: Back of each rabbit- Coverage: 20-30 % of the body surface- Type of wrap if used: Guaze bandaging and Saran Wrap and over wrapped with several layers of 75 millimeter Elastoplast Tape. A collar was also applied to each animal.REMOVAL OF TEST SUBSTANCE- Washing (if done): 24 hours following test application, the bandages and collars were removed and the test sites were wiped clean with dry, disposable paper towels.- Time after start of exposure: Each test site was observed for skin irritation at 24 and 72 hours after test article application.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Animal No. 5059, Male
- Time point:
- 24 h
- Score:
- 1
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Animal No. 5059, Male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Animal No. 5059, Male
- Time point:
- 24 h
- Score:
- 1
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Animal No. 5059, Male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Animal No. 5065, Male
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Animal No. 5065, Male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- Animal No. 5065, Male
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- Animal No. 5065, Male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Animal No. 5062, Female
- Time point:
- 24 h
- Score:
- 0.5
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Animal No. 5062, Female
- Time point:
- 72 h
- Score:
- 0.5
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- Animal No. 5062, Female
- Time point:
- 24 h
- Score:
- 0.5
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- Animal No. 5062, Female
- Time point:
- 72 h
- Score:
- 0.5
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- Animal No. 5063, Male
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- Animal No. 5063, Male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- Animal No. 5063, Male
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- Animal No. 5063, Male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- Animal No. 5058, Female
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- Animal No. 5058, Female
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- Animal No. 5058, Female
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- Animal No. 5058, Female
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- Animal No. 5064, Female
- Time point:
- 24 h
- Score:
- 1
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- Animal No. 5064, Female
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- Animal No. 5064, Female
- Time point:
- 24 h
- Score:
- 0.5
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- Animal No. 5064, Female
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- No 48h data
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- No 48h data
- Irritant / corrosive response data:
- Calculations for Primary Skin Irritation Score: 3.0/12 + 2.5/12=0.5 (Score: The average of all the erythema scores plus the average of all the edema scores)
- Other effects:
- Mortality:None of the rabbits died during the 3-day study period.Pharmacotoxic signs:All of the animals appeared normal the 3-day study period, except for one male animal of the Intact group, which had diarrhea at 24 and 48 hours.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Based upon the data obtained, the article TS2-16B Trimethyl borate, would not be considered a primary skin irritant.
- Executive summary:
3 male and 3 female young adult New Zealand white rabbits were subjected to skin irritation test to evaluate the test substance, Trimethyl borate. From this group of randomly selected animals, three rabbits were assigned to an intact group and three rabbits were assigned to an abraded group.
24 hours following test application, the bandages and collars were removed and the test sites were wiped clean with dry, disposable paper towels and observed for the next 72 hours for the following:
Primary Skin Irritation:
Each test site was observed for skin irritation at 24 and 72 hours after test article application.
Mortality:
The rabbits were observed twice daily (AM & PM) for mortality for a total of 3 days.
Pharmacotoxic signs:
The rabbits were observed for pharmacotoxic signs at 24 hours and once daily thereafter for a total of 3 days.
Body weights:
Body weights were obtained at study initiation (control) and study termination.
Based upon the data obtained (Primary Irritation Score = 0.5), the article TS2-16B Trimethyl borate, would not be considered a primary skin irritant.
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