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EC number: 260-135-8 | CAS number: 56375-79-2
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Tributylmethylammonium chloride
- EC Number:
- 260-135-8
- EC Name:
- Tributylmethylammonium chloride
- Cas Number:
- 56375-79-2
- Molecular formula:
- C13H30N.Cl
- IUPAC Name:
- tributyl(methyl)azanium chloride
- Details on test material:
- - Name of test material (as cited in study report): Aliquat 175
- Physical state: clear liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: MJV59-115-1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kuiper Rabbitry, Gary, Indiana
- Age at study initiation: at least 12 weeks
- Weight at study initiation: between 2.01 - 2.55 kg
- Housing: individually in stainless steel cages
- Diet: Purina Rabbit Chow, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22
- Humidity (%): 30-70
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: the dorsal and ventral areas of the trunks of the rabbits were shaved (electric clippers), the areas shaved were approximately 30% of the total body surface area
- % coverage: approx. 10
- Type of wrap if used: Two layers of porous gauze dressing and a sleeve of plastic sheeting was fitted over the shaven trunk of the animal and secured in place with non-irritating surgical tape.
REMOVAL OF TEST SUBSTANCE
- Washing: remaining test article wiped off
- Time after start of exposure: 24 hours - Duration of exposure:
- 24 hours
- Doses:
- 2000 and 200 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed frequently during the day of dosing and once daily for 14 days following dosing. The weight of each animal was determined prior to dosing, and for survivors at 7 days and at the end of the 14 days.
- Necropsy of survivors performed: yes - Statistics:
- At the end of the observation period, calculations of the LD50 and 95% confidence limits are performed, if necessary, by the method of moving averages, using the tables constructed by Weil, (Weil C.C.: Table for Convenient Calculations of Median Effective Dose (LD50 and ED50) and lnstruction in Their use). Biometrics, 8, 249 (1952).
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 000 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 851.928 - <= 2 159.911
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 500 mg/kg bw
- Based on:
- act. ingr.
- 95% CL:
- >= 1 388.925 - <= 1 619.933
- Remarks on result:
- other: Aliquat 175 consists of ca. 75 % tributylmethylammonium chloride (56375-79-2) and ca. 25 % water
- Mortality:
- At the 2000 mg/kg body weight level, 50% mortality occurred during the 14 day observation period. At the 200 mg/kg body weight level, no mortality occurred during the 14 day observation period.
- Clinical signs:
- other: At the 2000 mg/kg bw dose level, all animals were extremely hyperactive (excessive jumping and thrashing about in the cage) immediately following dosing. Most likely indicative of discomfort from application of the test material. Additionally, edema at th
- Gross pathology:
- There were no internal or external changes found in the 200 mg/kg dose group. In the 2000 mg/kg dose group no gross changes were found however, some minor effects were observed. For details see the table in: " Any other information on results incl. tables"
Any other information on results incl. tables
Table 1: Body weight and clinical signs
| DOSE group 2000 mg/kg | |||||||
RABBIT |
SEX | Initial BWT | Dose | 7 DAY BWT | 14 DAY BWT | FATE | FINDINGS |
| (kg) | (grams) | (kg) | (kg) | ||||
| 546 | M | 2.25 | 4.50 | --- | --- | Day of dosing | External: No gross changes observed. InternaL: Stomach slightly distended with gas, no other gross changes observed. |
| 547 | M | 2.30 | 4.60 | 2.34 | 2.52 | Survived | External: Eschar at the application site, no other gross changes observed.Internal: No gross changes observed. |
| 548 | M | 2.36 | 4.72 | --- | --- | Day of dosing | External: No gross changes observed.Internal: No gross changes observed. |
| 549 | M | 2.32 | 4.64 | 2.39 | 2.65 | Survived | External: Eschar at the application site, no other gross changes observed.Internal: No gross changes observed. |
| 550 | M | 2.51 | 5.02 | --- | --- | Day of dosing | External: No gross changes observed.Internal: No gross changes observed. |
| 551 | F | 2.42 | 4.84 | --- | --- | day 1 | External: Erythema and edema present at theapplication site, no other gross changes observed.Internal: Stomach slightly distended with gas, no other gross changes observed. |
| 552 | F | 2.55 | 5.10 | --- | --- | Day of dosing | External: No gross changes observed.Internal: Liver appeared mottled, no gross changes observed. |
| 553 | F | 2.32 | 4.64 | 2.20 | 2.33 | Survived | External: Eschar at the application site, no other gross changes observed.Internal: No gross changes observed. |
| 554 | F | 2.10 | 4.20 | 1.96 | 2.16 | Survived | External: Eschar at the application site, no other gross changes observed.Internal: No gross changes observed. |
| 555 | F | 2.01 | 4.02 | 1.82 | 1.97 | Survived | External: Eschar at the application site, no other gross changes observed.Internal: No gross changes observed. |
Table 2: Body weight and clinical signs
| DOSE group 200 mg/kg | |||||||
| RABBIT | SEX | Initial BWT | Dose | 7 DAY BWT | 14 DAY BWT | FATE | FINDINGS |
| (kg) | (grams) | (kg) | (kg) | ||||
| 594 | F | 2.10 | 0.42 | 2.29 | 2.53 | Survived | External: No gross changes observed.Internal: No gross changes observed. |
| 595 | F | 2.21 | 0.44 | 2.43 | 2.60 | Survived | " " |
| 596 | F | 2.24 | 0.45 | 2.42 | 2.58 | Survived | " " |
| 597 | F | 2.11 | 0.42 | 2.34 | 2.36 | Survived | " " |
| 598 | F | 2.29 | 0.46 | 2.41 | 2.47 | Survived | " " |
| 601 | M | 2.23 | 0.45 | 2.41 | 2.49 | Survived | " " |
| 602 | M | 2.22 | 0.44 | 2.38 | 2.43 | Survived | " " |
| 603 | M | 2.10 | 0.42 | 2.26 | 2.43 | Survived | " " |
| 604 | M | 2.25 | 0.45 | 2.39 | 2.52 | Survived | " " |
| 605 | M | 2.47 | 0.49 | 2.63 | 2.75 | Survived | " " |
Probitanalysis according to Finney including the 1000 mg/kg dose level of the second study:
Males
Dose: Number: Number survivors:
200 5 5
1000 5 5
2000 5 2
LD50 95% KI (lower) 95% KI (upper)
--------- -------------- --------------
1952.133 1755.310 2171.025
Intercept Slope
--------- ---------
-79.24 10.458
Goodness-of-Fit - Test (Pearson Chi-Square)
p-value
---------
1.0000
Females
Dose: Number: Number survivors:
200 5 5
1000 5 5
2000 5 3
LD50 95% KI (lower) 95% KI (upper)
--------- -------------- --------------
2052.734 1831.243 2301.015
Intercept Slope
--------- ---------
-74.24 9.735
Goodness-of-Fit - Test (Pearson Chi-Square)
p-value
---------
1.0000
Males and Females
Dose: Number: Number survivors:
200 10 10
1000 10 10
2000 10 5
LD50 95% KI (lower) 95% KI (upper)
--------- -------------- --------------
2000.000 1851.928 2159.911
Intercept Slope
--------- ---------
-76.76 10.099
Goodness-of-Fit - Test (Pearson Chi-Square)
p-value
---------
1.0000
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on an acute dermal toxicity study performed with MTBAC according to OPPTS 870.1200 guideline and GLP principles, it is concluded that the LD50 of MTBAC exceeds 2000 mg/kg bw/day. Corrected for the purity the LD50 for acute dermal exposure is ca. 1500 mg/kg bw.
- Executive summary:
In an OPPTS 870.1200 guideline study, rabbits were treated with 200 and 2000 mg/kg bw. The test substance was applied dermally under occlusive conditions for 24 hours. No mortality occurred in the 200 mg/kg bw dose group however, 5 out of 10 animals died in the 2000 mg/kg bw dose group. Erythema, edema and eschar formation were observed during the observation period in the 2000 mg/kg bw dose group. In animals of the 200 mg/kg bw dose group edema and erythema were observed during day 1 to 3. No effects were observed after necropsy. The LD50 for acute dermal exposure is ca. 2000 mg/kg bw in the rabbit. The test item consists of ca. 75 % tributylmethylammonium chloride and ca. 25 % water. Corrected for the purity the LD50 for acute dermal exposure is ca. 1500 mg/kg bw.
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