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EC number: 268-938-5 | CAS number: 68155-09-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From October 20, 1999 to November 3, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- Feb 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Amides, coco, N-[3-(dimethylamino)propyl], N-oxides
- EC Number:
- 268-938-5
- EC Name:
- Amides, coco, N-[3-(dimethylamino)propyl], N-oxides
- Cas Number:
- 68155-09-9
- Molecular formula:
- Unspecified
- IUPAC Name:
- Amides, coco, N-[3-(dimethylamino)propyl], N-oxides
- Details on test material:
- - Purity: approximately 81%
- Physical state: off white paste
- Lot/batch No.: 876 Tk
- Storage condition of test material: room temperature, in the dark
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source:
- Batch No.of test material: 876 TK
- Date received: 10 May 1999
- Purity: 92%
- Physical appearance: white paste
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test material was used as supplied. It was weighed out according to the animals individual body weight.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Crl: CD (SD) IGS BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK)
- Age at study initiation: approximately eight to twelve weeks old
- Weight at study initiation: males 206 to 232 g, and the females 214 to 225 g.
- Housing: in suspended polypropylene cages furnished with wood flakes. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 ºC
- Humidity (%): 30-70 %
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light and twelve hours darkness
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with cotton wool moistened with distilled water to remove any residual test material.
- Time after start of exposure: After the 24-hour contact period
TEST SITE
- Area of exposure: Back and flank of animals
- % coverage: approximating to 10% of the total body surface area.
- Type of wrap if used: Surgical gauze and self-adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test substance was wiped off with cotton wool moistened with distilled water
- Time after start of exposure: After a 24-hour contact period
TEST MATERIAL
- Amount applied: not specified
- Constant volume or concentration used: yes
- For solids, paste formed: yes
VEHICLE
- No vehicle used. The undiluted test substance was used. - Duration of exposure:
- 24-hours
- Doses:
- 2174 mg/kg (equivalent to 2000 mg/kg bodyweight of pure test material).
- No. of animals per sex per dose:
- Ten animals (five males and five females)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Scoring system: Scale from Draize J H (1977) - Statistics:
- Mortality data was used to estimate the acute dermal median lethal dose (LD50) of the test substance
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 174 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: The dose 2174 mg/kg is equivalent to 2000 mg/kg bodyweight of pure test material
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the study. Very slight to well-defined erythema was noted at the treatment sites of all animals one and two days after dosing, in nine animals three days after dosing and in four animals four days after dosi
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- Residual test material was noted at the treatment sites of all animals during the study and prevented accurate evaluation of oedema in two males one to five days after dosing.
One female showed body weight loss during the first week andd expected gain in body weight during the second week. All other animlas showed normal body weights.
Any other information on results incl. tables
Table 1: Individual clinical observations and mortality data
Dose level [mg/kg] |
Animal number and sex |
Effects noted after dosing (hours) |
Effects noted after dosing (days) |
||||||||||||||||
1/2 |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2174 |
1-0 male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1-1 male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-2 male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-3 male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-4 male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-0 female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-1 female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-2 female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-3 female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-4 female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
0 = no signs of systemic toxicity
Table 2.1: Individual dermal reactions - males
Dose level [mg/kg] |
Animal number and sex |
Observation |
Effects noted after dosing (days) |
|||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||
2174 |
1-0 male |
Erythema Oedema Other |
2 1 Rt |
2 1 Rt |
1 1 Rt |
0 0 Rt |
0 0 Rt |
0 0 Rt |
0 0 Rt |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
1-1 male |
Erythema Oedema Other |
2 od RtBr |
2 od RtBr |
1 od RtBr |
0 od RtBr |
0 od RtBr |
0 0 Rt |
0 0 Rt |
0 0 Rt |
0 0 Rt |
0 0 Rt |
0 0 Rt |
0 0 G |
0 0 G |
0 0 G |
|
1-2 male |
Erythema Oedema Other |
2 1 Rt |
1 1 Rt |
1 1 Rt |
0 0 Rt |
0 0 Rt |
0 0 Rt |
0 0 Rt |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
1-3 male |
Erythema Oedema Other |
2 1 Rt |
2 1 Rt |
2 1 Rt |
1 1 Rt |
0 0 Rt |
0 0 Rt |
0 0 Rt |
0 0 Rt |
0 0 Rt |
0 0 Rt |
0 0 Rt |
0 0 Rt |
0 0 G |
0 0 G |
|
1-4 male |
Erythema Oedema Other |
2 od Rt |
2 od Rt |
1 od Rt |
0 od RtBs |
0 od RtBr |
0 0 Rt |
0 0 Rt |
0 0 Rt |
0 0 Rt |
0 0 Rt |
0 0 Rt |
0 0 G |
0 0 G |
0 0 G |
|
0 = no signs of dermal irritation; G = glossy skin; Bs = Bleeding; Rt = residual test material; Br = light brown discoloration of the epidermis; od = adverse reactions prevent accurate evaluation of oedema
Table 2.2: Individual dermal reactions - females
Dose level [mg/kg] |
Animal number and sex |
Observation |
Effects noted after dosing (days) |
|||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||
2174 |
2-0 female |
Erythema Oedema Other |
2 1 Rt |
1 1 Rt |
1 1 RtD |
1 1 RtD |
0 0 RtCf |
0 0 Cf |
0 0 Cf |
0 0 Cf |
0 0 Cf |
0 0 G |
0 0 G |
0 0 G |
0 0 G |
0 0 G |
2-1 female |
Erythema Oedema Other |
2 1 RtBr |
2 1 RtBr |
2 1 RtBrD |
1 0 RtBrD |
0 0 RtBrCf |
0 0 Cf |
0 0 Cf |
0 0 Cf |
0 0 Cf |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
2-2 female |
Erythema Oedema Other |
2 1 Rt |
2 0 Rt |
1 0 RtD |
0 0 RtD |
0 0 RtCf |
0 0 Cf |
0 0 Cf |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
2-3 female |
Erythema Oedema Other |
2 1 RtBr |
2 1 RtBr |
2 1 RtBrD |
2 0 RtBrD |
0 0 RtBrCf |
0 0 BrCf |
0 0 BrCf |
0 0 Cf |
0 0 Cf |
0 0 G |
0 0 G |
0 0 G |
0 0 G |
0 0 G |
|
2-4 female |
Erythema Oedema Other |
2 1 Rt |
1 0 Rt |
0 0 Rt |
0 0 D |
0 0 Cf |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
0 = no signs of dermal irritation; D = desquamation; Br = light brown discoloration of the epidermis; G = glossy skin; Cf = crust formation; Rt = residual test material
Table 3: Individual bodyweight and weekly changes
Doselevel mg/kg |
Animal Number and Sex |
Bodyweight (g) atDay |
Bodyweight Gain (g) During Week |
|||
|
|
0 |
7 |
14 |
1 |
2 |
2174 |
1-0 Male |
206 |
238 |
286 |
32 |
48 |
1-1 Male |
228 |
285 |
336 |
57 |
51 |
|
1-2 Male |
232 |
280 |
345 |
48 |
65 |
|
1-3Male |
220 |
257 |
312 |
37 |
55 |
|
1-4 Male |
215 |
201 |
322 |
46 |
61 |
|
2-0 Female |
214 |
215 |
234 |
1 |
19 |
|
2-1 Female |
220 |
225 |
236 |
5 |
11 |
|
2-2 Female |
225 |
220 |
245 |
-5 |
25 |
|
2-3 Female |
224 |
235 |
265 |
11 |
30 |
|
2-4 Female |
225 |
226 |
250 |
1 |
24 |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test substance in the Sprague-Dawley CD strain rat was found to be greater than 2174 mg/kg bodyweight (equivalent to 2000 mg/kg bodyweight of pure test material).
- Executive summary:
The Acute Dermal Toxicity assay for the test substance was performed in Sprague-Dawley CD rats. One female group and one male group, of 5 animals each one, were treated with a single dose of 2174 mg/kg bodyweight, equivalent to 2000 mg/kg bodyweight of pure test material (Limit test). The test material was applied uniformly to an area of shorn skin (approximating to 10% of the total body surface area). A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage. After the 24-hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water. Clinical observation was conducted at 1/2,1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Body weight was controlled before the administration, on day 0 and on days 7 and 14 after the administration. All animals were subjected to gross necropsy. No test substance related effects were noted from clinical observations or post-mortem examination. The acute dermal median lethal dose (LD50) of the test substance in the Sprague-Dawley CD strain rat was found to be greater than 2174 mg/kg bodyweight (equivalent to 2000 mg/kg bodyweight of pure test material).
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