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EC number: 950-347-5 | CAS number: -
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Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 June 2015 to 16 September 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- The pretest body weight of Animal 5 exceeded the +/- 20% of the mean body weight by 2 grams. No impact is expected since the degree of weight deviation is negligble. Each animal received a dose based on their individual body weight.
- Principles of method if other than guideline:
- Deviation to the Protocol
The pretest body weight of Animal 5 exceeded the +/- 20% of the mean body weight by 2 grams. No impact is expected since the degree of weight deviation is negligible. Each animal received a dose based on their individual body weight.
Amendment to the Protocol
At the request of the Sponsor, additional analysis was conducted according to the current Globally Harmonized System of Classification and Labeling of Chemicals.
The animal supplier, Charles River, was clarified in the protocol subsequent to study initiation. - GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- 1,2-Cyclohexanedicarboxylic Acid, 1-(phenylmethyl) ester, ester with 2,2,4-trimethyl, 1,3-petanediol mono(2-methyl propanoate)
- EC Number:
- 950-347-5
- Cas Number:
- 1661012-65-2
- Molecular formula:
- C27H40O6
- IUPAC Name:
- 1,2-Cyclohexanedicarboxylic Acid, 1-(phenylmethyl) ester, ester with 2,2,4-trimethyl, 1,3-petanediol mono(2-methyl propanoate)
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test Animals
Animals were received from Charles River, Stone Ridge, NY on 19 May 2015 and 09 Jun 2015. Following an acclimation period of at least five days, five healthy male and five healthy, non-pregnant and nulliparous female Sprague-Dawley rats were randomly assigned to the treatment groups.
The animals were born 23 Mar 2015, 13 Apr 2015 and 20 Apr 2015. The pretest body weight range was 243 - 285 g for males and 204 - 223 g for females.
The animals were identified by an indelible body mark and individually housed in suspended wire cages. Absorbent paper bedding was placed beneath the cages and changed at least three times per week. Fresh PMI Rat Chow (Diet #5012) was provided daily. Water was available ad libitum. The animal room, reserved exclusively for rats on acute tests, was temperature controlled, had a 12-hour light/dark cycle, and was kept clean and vermin free.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Site Preparation
The day prior to application of the test article, the dorsal area of the trunk of each animal was clipped free of hair. The clipped area began at the shoulders and extended to the hipbone and half way down the flank of each side of the animal. The prepared site was approximately 10% of the body surface and remained intact.
Dosing
A single dose of the test article was applied to the prepared site, over a porous gauze dressing at a dose level of 2000 mg/kg. The dose was based on the sample weight as calculated from the specific gravity. The torso was covered with a piece of porous dressing (semi-occlusive) to retain the gauze patch and was secured with non-irritating tape. The test article remained in contact with the skin for 24 hours at which time the wrappings were removed. Residual test article was removed by gently washing with distilled water. - Duration of exposure:
- 24 hours
- Doses:
- Test article applied unchanged (100% concentration)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Type and Frequency of Observations
In vivo
- The test sites were scored for dermal irritation at 24 hours postdose and on Day 14 using the numerical Draize scoring code below. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction. Additional signs were described.
Erythema and Eschar
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Edema
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well-defined by definite raising) 2
Moderate edema (raised approximately 1.0 mm) 3
Severe edema (raised more than 1.0 mm, extending beyond the area of exposure) 4
Type and Frequency of Observations (continued)
The animals were observed 1and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects.
Body weights were recorded pretest, weekly and at termination.
Post Mortem
– All animals were humanely sacrificed using CO2 following study termination and were examined for gross pathology.
Analysis of Data
An estimate of the LD50 was made based on mortality occurring during the study. Analysis was conducted according to the current Globally Harmonized System of Classification and Labeling of Chemicals. - Statistics:
- None - N/A
Results and discussion
- Preliminary study:
- None
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat. (total fraction)
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- All five male and all five female rats survived the 2000 mg/kg 24-hour dermal exposure.
- Clinical signs:
- other: Dermal Observations At 24 hours post-dosing, erythema was absent to well-defined and edema was absent. By Day 14, erythema was absent to very slight and edema was absent; flaking skin was observed. Systemic Observations Abnormal physical signs including
- Gross pathology:
- Gross necropsy of all animals revealed no observable abnormalities.
Any other information on results incl. tables
Table 1. Body Weights and Dose Volume |
|||||
Animal No. |
Sex |
Dose Volume (mL) |
Body Weight (g) |
||
Day 0 |
Day 7 |
Day 14 |
|||
1 |
Male |
0.43 |
243 |
273 |
307 |
2 |
Male |
0.45 |
252 |
288 |
326 |
3 |
Male |
0.46 |
258 |
295 |
331 |
4 |
Male |
0.46 |
257 |
285 |
314 |
5 |
Male |
0.51 |
285 |
334 |
385 |
Mean |
259 |
295 |
333 |
||
S.D. |
15.7 |
23.2 |
30.8 |
||
# |
5 |
5 |
5 |
||
|
|||||
6 |
Female |
0.37 |
207 |
211 |
213 |
7 |
Female |
0.40 |
223 |
238 |
244 |
8 |
Female |
0.39 |
217 |
234 |
252 |
9 |
Female |
0.37 |
204 |
219 |
224 |
10 |
Female |
0.39 |
218 |
231 |
234 |
Mean |
214 |
227 |
233 |
||
S.D. |
8.0 |
11.2 |
15.5 |
||
# |
5 |
5 |
5 |
Table 2. Dermal Observations |
|||||||||||
Time Periods |
Animal Number and Sex |
||||||||||
Male |
Female |
||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
||
24-hour |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
2 |
1 |
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Day 14 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1, f |
0 |
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
f = flaking skin
Table 3. Necropsy Observations |
||||||||||
Animal Number |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
Sex |
Male |
Female |
||||||||
Death (D) / Sacrifice (S) |
S |
S |
S |
S |
S |
S |
S |
S |
S |
S |
Observation |
|
|||||||||
Appeared normal / No findings |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X: Observed
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Based on the results observed, the dermal LD50 of Santicizer P1700 was determined to be greater than 2000 mg/Kg of body weight in rats. According to GHS Classification, Santicizer P1700 meets the criteria to be classified as Acute Toxic Category 5.
- Executive summary:
A key EPA Guideline OPPTS 870.1200 study was conducted to determine the potential for toxicity of the test material (Santicizer P1700) when applied dermally. Five male and five female Sprague-Dawley rats were dosed dermally with Santicizer P1700 at 2000 mg/Kg of body weight. The test material was kept in contact with the skin for 24 hours and dermal responses recorded at 24 hours post exposure and on Day 14. Animals were observed for toxicity and pharmacological effects at 1 and 4 hours post exposure and once daily for 14 days. Body weights were recorded pretest, weekly and at termination and all animals were examined for gross pathology.
No mortality was observed through the study period and abnormal physical signs such as chromorhinorrhea, wetness and soiling of the anogenital area, erythema on the ears and partially chewed food on the cage pan liner were observed. At 24 hours post exposure, erythema was absent to well-defined and edema was absent. By Day 14, erythema was absent to very slight and edema was absent; flaking skin was observed. All animals in both sexes gained body weight by study termination and gross necropsy revealed no remarkable findings.
Based on the results observed, the dermal LD50 of Santicizer P1700 was determined to be greater than 2000 mg/Kg of body weight in rats. According to GHS Classification, Santicizer P1700 meets the criteria to be classified as Acute Toxic Category 5.
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