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EC number: - | CAS number: -
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![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 December 2010 to 29 December 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to EU, OECD and US EPA test guidance in compliance with GLP and reported with a valid GLP certificate
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- Product name: Reactive Orange F08-0314
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species and strain: RjHan:(WI) Wistar rats
Source: Laboratoire Elevage Janvier, B.P. 4105, Route des Chênes Secs, 53940 Le Genest-St-Isle CEDEX FRANCE
Hygienic level at arrival: SPF
Hygienic level during the study: Standard housing conditions
Justification of strain: The Wistar rat is one of the standard rodent species used in acute toxicity studies
Number of animals: 5 animals/sex
Sex: Male and female, female rats were nulliparous and non-pregnant.
Age of animals at study start: Young adult rats
Body weight range at dosing: Between 210 g and 249 g
Acclimatization time: 5 days
Animal health: Only healthy animals were used for the study. The veterinarian certified the health status.
Room-Box: 242/6
Housing: Individual caging
Cage type: Type II. polypropylene/polycarbonate
Bedding: Laboratory bedding: Lignocel Hygienic Animal Bedding produced by J. Rettenmaier & Söhne GmbH+Co.KG (Holzmühle 1, 73494 Rosenberger, Germany);
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20.4- 25.0 °C
Relative humidity: 24 - 64 %
Ventilation: 15-20 air exchanges/hour
Enrichment: Rodents were housed with deep wood sawdust bedding to allow digging and other normal rodent activities.
The temperature and relative humidity was recorded twice daily during the study.
Food and Water Supply
Animals received ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany ad libitum, and tap water from the municipal supply, as for human consumption from 500 ml bottle ad libitum. The food is not considered to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
Water quality control analysis is performed once every three months and microbiological assessment is performed monthly, by Veszprém County Institute of State Public Health and Medical Officer Service (ÁNTSZ, H-8201 Veszprém, József A.u.36., Hungary). The quality control results are retained in the archives at LAB Research Ltd.
Identification
The individual identification was performed using numbers written on the tail with a marker pen. The numbers were given on the basis of LAB Research Ltd.' s Master File for each animal allocated to the treatment groups. The cages were identified by cards containing information about study code, sex, dose group, cage number and individual animal numbers.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- The back of each animal was shaved (approximately 10 % area of the total body surface) approximately 24 hours prior to treatment. The test item was applied as a single dose as supplied to the shaved skin and remained in contact with the skin for the 24- hour exposure period. For that purpose, the appropriate amount of the test item was moistened with distilled water and distributed as uniformly as possible. Sterile gauze pads were placed on the skin of rats to cover the test item. These gauze pads were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semi occlusive plastic wrap for 24 hours.
At the end of the exposure period, the area of skin treated with the test item was washed with water of body temperature. - Duration of exposure:
- 24 hours
- Doses:
- The test item was not expected to be lethal at 2000 mg/kg bw. A limit test was therefore performed.
- No. of animals per sex per dose:
- 5 males/5 females per dose
- Control animals:
- no
- Details on study design:
- Clinical Observations
Clinical observations were performed on the day of treatment at 1 and 5 hours after application of the test item and once each day for 14 days thereafter. Observations included the skin and fur, eyes and mucous membranes, the respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Measurement of Body Weight
The body weights were recorded on Day 0 (before test item administration) and on Days 3, 7 and 14.
NECROPSY
All animals were anaesthetised with Euthasol®40% and exsanguinated. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed. All macroscopic changes were recorded. - Statistics:
- No data
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred after a 24-hour dermal exposure of Reactive Orange F08-0314 administered at 2000 mg/kg bw to RjHan:(WI) Wistar rats followed by a 14-day observation period.
- Clinical signs:
- other: No clinical signs were observed after the treatment with the test item or during the 14 day observation period.
- Gross pathology:
- A single 24 hour dermal application of Reactive Orange F08-0314 to the Rj Han: (WI) rat at a dose level of 2000 mg/kg bw was not accompanied with any macroscopic test item-related findings.
- Other findings:
- Orange staining was recorded on the skin in all animals after dosing. The discoloration of the skin lasted up to 13 days in all animals. No other local dermal signs were observed.
Any other information on results incl. tables
CLINICAL OBSERVATIONS
INDIVIDUAL CLINICAL OBSERVATIONS
Study Code: 10296-002P Test System: RjHan: WI Rat Test Item Reactive Orange F08-0314
DOSE LEVEL: 2000 mg/kg
Cage No. |
Animal No./Sex |
Observations |
Observation days |
Frequency |
|||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||
1h |
5h |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
1 |
3403 Male |
Symptom Free Orange skin |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
6/16 |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
10/16 |
|||
2 |
3404 Male |
Symptom Free Orange skin |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
6/16 |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
10/16 |
|||
3 |
3405 Male |
Symptom Free Orange skin |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
6/16 |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
10/16 |
|||
4 |
3406 Male |
Symptom Free Orange skin |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
6/16 |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
10/16 |
|||
5 |
3407 Male |
Symptom Free Orange skin |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
6/16 |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
10/16 |
|||
6 |
3408 Female |
Symptom Free Orange skin |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
4/16 |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
12/16 |
|||
7 |
3409 Female |
Symptom Free Orange skin |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
4/16 |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
12/16 |
|||
8 |
3410 Female |
Symptom Free Orange skin |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
3/16 |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
13/16 |
|||
9 |
3411 Female |
Symptom Free Orange skin |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
4/16 |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
12/16 |
|||
10 |
3512 Female |
Symptom Free Orange skin |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
6/16 |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
10/16 |
Remarks: +: Present
h=hour(s) Treatment day = Day 0
Frequency of observations = number of occurrence of observation / total number of observations
BODY WEIGHT DATA
INDIVIDUAL BODY WEIGHT AND BODY WEIGHT GAIN
Study Code: 10/296-002P Test System: Rj Han: WI Rat Test Item: Reactive Orange F08-0314
DOSE LEVEL: 2000 mg/kg
Cage No. |
Animal No. / Sex |
Body Weight (g) Days |
Body Weight Gain (g) |
||||||
0 |
3 |
7 |
14 |
0-3 |
3-7 |
7-14 |
0-14 |
||
1 |
3403 Male |
249 |
260 |
295 |
348 |
11 |
35 |
53 |
99 |
2 |
3404 Male |
240 |
258 |
289 |
334 |
18 |
31 |
45 |
94 |
3 |
3405 Male |
232 |
254 |
278 |
328 |
22 |
24 |
50 |
96 |
4 |
3406 Male |
243 |
260 |
282 |
330 |
17 |
22 |
48 |
87 |
5 |
3407 Male |
242 |
266 |
292 |
344 |
24 |
26 |
52 |
102 |
Mean: |
241.2 |
259.6 |
287.2 |
336.8 |
18.4 |
27.6 |
49.6 |
95.6 |
|
Standard deviation: |
6.1 |
4.3 |
7.0 |
8.8 |
5.0 |
5.3 |
3.2 |
5.7 |
|
6 |
3408 Female |
215 |
219 |
225 |
237 |
4 |
6 |
12 |
22 |
7 |
3409 Female |
222 |
228 |
245 |
261 |
6 |
17 |
16 |
39 |
8 |
3410 Female |
210 |
217 |
227 |
243 |
7 |
10 |
16 |
33 |
9 |
3411 Female |
223 |
226 |
237 |
250 |
3 |
11 |
13 |
27 |
10 |
3412 Female |
226 |
231 |
237 |
253 |
5 |
6 |
16 |
27 |
Mean: |
219.2 |
224.2 |
234.2 |
248.8 |
5.0 |
10.0 |
14.6 |
29.6 |
|
Standard deviation: |
6.5 |
6.0 |
8.2 |
9.2 |
1.6 |
4.5 |
1.9 |
6.5 |
Remarks: Treatment day – Day 0
MACROSCOPIC FINDINGS
INDIVIDUAL INTERNAL AND EXTERNAL MACROSCOPIC OBSERVATIONS
Study Code: 10/296-002P Test System: Rj Han: WI Rat Test Item: Reactive Orange F08-0314
DOSE LEVEL: 2000 mg/kg
Cage No. |
Animal No. / Sex |
Necropsy Date |
External Observations |
Internal Observations |
Organ/Tissue |
1 |
3403 Male |
29 December 2010 |
No external observations |
No internal observations |
Not applicable |
2 |
3404 Male |
29 December 2010 |
No external observations |
No internal observations |
Not applicable |
3 |
3405 Male |
29 December 2010 |
No external observations |
No internal observations |
Not applicable |
4 |
3406 Male |
29 December 2010 |
No external observations |
No internal observations |
Not applicable |
5 |
3407 Male |
29 December 2010 |
No external observations |
No internal observations |
Not applicable |
6 |
3408 Female |
29 December 2010 |
No external observations |
No internal observations |
Not applicable |
7 |
3408 Female |
29 December 2010 |
No external observations |
No internal observations |
Not applicable |
8 |
3410 Female |
29 December 2010 |
No external observations |
No internal observations |
Not applicable |
9 |
3411 Female |
29 December 2010 |
No external observations |
No internal observations |
Not applicable |
10 |
3412 Female |
29 December 2010 |
No external observations |
In estrus |
Uterus |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item Reactive Orange F08-0314 was found to be higher than 2000 mg/kg body weight in male and female RjHan:(WI) Wistar rats.
- Executive summary:
An acute dermal toxicity study was performed with test item Reactive Orange F08 -0314 in RjHam;(WI) Wistar rats, in compliance with OECD Guideline No.: 402 (24th Feb. 1987), Commission Regulation (EC) No 440/2008, B.3 (L 142, 30 May 2008) and OPPTS 870.1200 (EPA 712 -C-98 -192, August 1998). This study is compliant with the Principles of Good Laboratory Practice (GLP) and reported with a valid GLP certificate.
A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied as supplied, moistened with distilled water, as a single dermal 24-hour exposure followed by a 14‑day observation period.
Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 3, 7 and 14.Ratswere euthanized and a gross macroscopic examination performed at the end of the 2-week observation period (Day 14).
The results of the study were summarized as follows:
Mortality
No mortality occurred.
Systemic clinical signs
No clinical signs were observed after the treatment with the test item or during the 14‑day observation period.
Local dermal signs
No local dermal signs were observed during the entire study period. However, orange staining was observed on the skin in all animals after dosing from Day 1 to Day 13.
Body weight
The body weight and body weight gain of Reactive Orange F08-0314 treated animals did not show any test item-related effect.
Necropsy
There was no evidence of test item-related observations at a dose level of 2000 mg/kg at necropsy. The uterus in estrus was seen in the female 3412.
Conclusions
The acute dermal median lethal dose (LD50) of the test itemReactive Orange F08-0314was found to be higher than 2000 mg/kg bw in male and female RjHan:(WI) Wistar rats.
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Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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