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EC number: 433-180-8 | CAS number: -
- Life Cycle description
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- Endpoint summary
- Appearance / physical state / colour
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
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- Toxicity to microorganisms
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- Toxicological Summary
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- Acute Toxicity
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- Additional toxicological data
![](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:
- 1999-02-03 to 1999-02-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in compliance with EEC-Guideline B3 and OECD Guidelines for testing chemicals 402 according to the good laboratory practice regulations annex of paragraph 19a, section 1 of the chemical law of July, 25, 1994.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name of test material (as cited in study report): Reaktiv-Orange DYPR934
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
TEST SYSTEM
Species Sprague Dawley rat
Strain HSD: Sprague Dawley SD
Origin HARLAN WINKELMANN
(SPF breeding colony)
Body weight at start of the experiment
Male animals Mean = 269 g (= 100 %)
S = ± 15.8 g
Min= 241 g (-10.4 %)
Max = 280 g (+4.1 %)
n = 5
Female animals Mean = 208 g (= 100 %)
S = ± 5.5 g
Min = 201 g (-3.4 %)
Max = 213 g (+2.4 %)
n = 5
Age at the start of the study: 6-10 weeks
Randomization Randomization schemes: 98.0941, 98.0704
Animal maintenance: in fully air-conditioned rooms in macrolon cages (type 3) on soft wood granulate one animal per cage.
Room temperature: 22 ± 3 °C
Relative humidity: 50 ± 20 %
Lighting time: 12 hours daily
Acclimatization: at least seven days
Food: ssniff® R/M-H(V 1534), ad libitum
Water: tap water in plastic bottles, ad libitum
Animal identification: cage numbering
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: Deionized water
- Details on dermal exposure:
- Before the dermal treatment the fur was mechanically removed from the dorsal skin of the animals over an area of approximately 30 cm2.
The appropriate amount of the test substance was moistened (0. 5 g of Reaktiv-Orange DYPR 934 with 0.5 mL of deionized water.)On two-ply gauze and aluminium foil (6X8 cm) and distributed as uniformly as possible. Together with the foil the test substance was administrated to the shaved and intact dorsal skin. The foil was held in place with an elastic plaster bandage fixed around the animal's body.
At the end of the dermal exposure period of 24 hours the bandage was removed and the treated skin area washed with warm water in order to remove any unabsorbed remnants of the substance. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw.
- No. of animals per sex per dose:
- 5 male and 5 female rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During the time the animals were weighed weekly.
- Necropsy of survivors performed: yes
- Other examinations performed:
Body weight development and clinical signs:
With exception of one female, all animals exhibited body weight gain throughout the study. No symptoms were observed after administration of 2000 mg/kg body weight.
The skin of the animals showed orange discolorations.
Autopsy findings:
The animals killed at the end of the observation period showed no macroscopically visible changes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: No substance related toxical effects.
- Gross pathology:
- The animals killed at the end of the observation period showed no macroscopically visible changes/ (lesions).
- Other findings:
Orange discolored skin
Any other information on results incl. tables
Table I: RESULTS AND COMMENTS |
|
Lethality |
No deaths occurred during the whole study |
Body weight development |
With exception of one female, all animals exhibited body weight gain throughout the study. No symptoms were observed after administration of 2000 mg/kg body weight. |
Clinical signs |
No symptoms were observed after administration of 2000 mg/kg body weight. -The skin of the animals showed orange discolorations. |
Autopsy findings |
The animals killed at the end of the observation period showed no macroscopically visible changes/ (lesions). |
Remarks: for individual data on clinical signs, bodyweight development and individual autopsy see tables under the rich text field: “Any other information on results incl. tables” |
Dose Range finding study
Test substance: Reaktiv-Orange DYPR 934
Vehicle: dionized water
Preparation of test compound:
To check the suitability of the vehicle 0.5 g of Reaktiv-Orange DYPR 934 was moistened with 0.5 mL deionized water. For individual dosing, both test item and vehicle were mixed in proportion stated above.
Table II: Bodyweights-Individual Bodyweights Study: 99. 0013-Acute Dermal Toxicity with Reaktiv-Orange DYPR 934 in Rats |
|
|||||||||
Bodyweights: Individual Bodyweights |
|
|||||||||
Day numbers relative to Start Date |
|
|||||||||
Group Sex |
Animal Number |
1 |
8 |
15 |
|
|||||
1m |
1 |
273 |
298 |
313 |
|
|||||
|
2 |
280 |
296 |
311 |
|
|||||
|
3 |
241 |
245* |
263* |
|
|||||
|
4 |
277 |
288 |
292 |
|
|||||
|
5 |
272 |
293 |
316 |
|
|||||
|
Mean |
268.6 |
284.0 |
299.0 |
|
|||||
|
S.D. |
15.8 |
22.1 |
22.2 |
|
|||||
|
N |
5 |
5 |
5 |
|
|||||
1 f |
6 |
212 |
221 |
220 |
|
|||||
|
7 |
204 |
214 |
222 |
|
|||||
|
8 |
213 |
219 |
224 |
|
|||||
|
9 |
212 |
221 |
233 |
|
|||||
|
10 |
201 |
207 |
216 |
|
|||||
|
Mean |
208.4 |
216.4 |
223.0 |
|
|||||
|
S.D. |
5.5 |
6.0 |
6.3 |
|
|||||
|
N |
5 |
5 |
5 |
|
|||||
*= result to left has an associated comment or marker Nominal Dose: Group 1-2000 mg/kg bodyweight |
|
|||||||||
Comments and Markers |
|
|||||||||
Measurement |
Group Sex |
Animal number |
Day Number |
Type |
Marker Comment |
|||||
Bodyweights |
1 m |
3 |
8 |
Out of range |
< |
|||||
|
15 |
Out of range |
< |
|||||||
Marker= implies value excluded from means |
||||||||||
Day numbers relative to Start Date |
||||||||||
Table III: Bodyweights Gains- Individual Bodyweight Gains |
||||||||||
|
Group Sex |
Animal Number |
From
To |
1
8 |
8
15 |
|||||
|
1m |
1 |
|
25 |
15 |
|||||
|
|
2 |
|
16 |
15 |
|||||
|
|
3 |
|
4* |
18* |
|||||
|
|
4 |
|
11 |
4 |
|||||
|
|
5 |
|
21 |
23 |
|||||
|
|
|
Mean |
15.4 |
15.0 |
|||||
|
|
|
S.D. |
8.9 |
7.0 |
|||||
|
|
|
N |
5 |
5 |
|||||
*= result to left has an associated comment or marker Nominal Dose: Group 1-2000 mg/kg bodyweight |
||||||||||
|
Group Sex |
Animal Number |
From
To |
1
8 |
8
15 |
|||||
|
1f |
6 |
|
9 |
-1 |
|||||
|
|
7 |
|
10 |
8 |
|||||
|
|
8 |
|
6 |
5 |
|||||
|
|
9 |
|
9 |
12 |
|||||
|
|
10 |
|
6 |
9 |
|||||
|
|
|
Mean |
8.0 |
6.6 |
|||||
|
|
|
S.D. |
1.9 |
4.9 |
|||||
|
|
|
N |
5 |
5 |
|||||
Table IV: Individual bodyweight gains
Measurement |
Group Sex |
Animal number |
Day Number |
Type |
Marker Comment |
|||||
Bodyweights |
1 m |
3 |
8 |
Out of range |
< |
|||||
|
15 |
Out of range |
< |
|||||||
Table V: Clinical observations-Clinical Signs by Animal Day number relative to start |
||||||||
Group Sex |
Animal Number |
Clinical Sign |
I 0-10 min Post dos |
I 10-30 min Post dos |
I 30-60 min Post dos |
1-2 hrs Post dos |
I 2-4 hrs Post dos |
I 4-8 hrs Pos dos |
1 m |
1 |
No abnormalities Detected |
X |
X |
X |
X |
X |
X |
|
2 |
No abnormalities Detected |
X |
X |
X |
X |
X |
X |
|
3 |
No abnormalities Detected |
X |
X |
X |
X |
X |
X |
|
4 |
No abnormalities Detected |
X |
X |
X |
X |
X |
X |
|
5 |
No abnormalities Detected |
X |
X |
X |
X |
X |
X |
|
6 |
No abnormalities Detected |
X |
X |
X |
X |
X |
X |
|
7 |
No abnormalities Detected |
X |
X |
X |
X |
X |
X |
|
8 |
No abnormalities Detected |
X |
X |
X |
X |
X |
X |
|
9 |
No abnormalities Detected |
X |
X |
X |
X |
X |
X |
|
10 |
No abnormalities Detected |
X |
X |
X |
X |
X |
X |
*= result to left has an associated comment or marker X=Present |
Table VI: Clinical observations-Clinical Signs by Animal Day number relative to start |
|
|||||||||||||||||
Group Sex |
Animal Number |
Clinical Sign |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
|
|
1 m |
1
|
No Abnormalities Detected |
- |
- |
- |
- |
- |
- |
X |
X |
X |
X |
X |
X |
X |
X |
X |
|
|
Skin discolored –large area |
o |
o |
o |
o |
o |
o |
- |
- |
- |
- |
- |
- |
- |
- |
- |
||
|
2
|
No Abnormalities Detected |
- |
- |
- |
- |
- |
- |
X |
X |
X |
X |
X |
X |
X |
X |
X |
|
|
Skin discolored –large area |
o |
o |
o |
o |
o |
o |
- |
- |
- |
- |
- |
- |
- |
- |
- |
||
|
3
|
No Abnormalities Detected |
- |
- |
- |
- |
- |
- |
X |
X |
X |
X |
X |
X |
X |
X |
X |
|
|
Skin discolored –large area |
o |
o |
o |
o |
o |
o |
- |
- |
- |
- |
- |
- |
- |
- |
- |
||
|
4 |
No Abnormalities Detected |
- |
- |
- |
- |
- |
- |
X |
X |
X |
X |
X |
X |
X |
X |
X |
|
|
Skin discolored –large area |
o |
o |
o |
o |
o |
o |
- |
- |
- |
- |
- |
- |
- |
- |
- |
||
|
5 |
No Abnormalities Detected |
- |
- |
- |
- |
- |
- |
X |
X |
X |
X |
X |
X |
X |
X |
X |
|
|
Skin discolored –large area |
o |
o |
o |
o |
o |
o |
- |
- |
- |
- |
- |
- |
- |
- |
- |
||
|
6 |
No Abnormalities Detected |
- |
- |
- |
- |
- |
- |
X |
X |
X |
X |
X |
X |
X |
X |
X |
|
|
Skin discolored –large area |
o |
o |
o |
o |
o |
o |
- |
- |
- |
- |
- |
- |
- |
- |
- |
||
|
7 |
No Abnormalities Detected |
- |
- |
- |
- |
- |
- |
X |
X |
X |
X |
X |
X |
X |
X |
X |
|
|
Skin discolored –large area |
o |
o |
o |
o |
o |
o |
- |
- |
- |
- |
- |
- |
- |
- |
- |
||
|
8 |
Skin discolored-large area |
o |
o |
o |
o |
o |
o |
o |
o |
o |
o |
o |
o |
o |
o |
o |
|
|
||||||||||||||||||
|
9 |
No Abnormalities Detected |
- |
- |
- |
- |
- |
- |
X |
X |
X |
X |
X |
X |
X |
X |
X |
|
|
Skin discolored –large area |
o |
o |
o |
o |
o |
o |
- |
- |
- |
- |
- |
- |
- |
- |
- |
||
|
10 |
Skin discolored –large area |
o |
o |
o |
o |
o |
o |
o |
o |
o |
o |
o |
o |
o |
o |
o |
X= present o= orange
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results obtained in the study the median lethal value (LD50) of Reaktiv-Orange DYPR 934 for the male and female rat is greater than 2000 mg/kg body weight.
- Executive summary:
In a 24 h acute toxicity dermal study (conducted in accordance with the OECD Guideline as well as the EEC Guideline), the acute dermal toxicity of Reaktiv-Orange DYPR 934 was tested only at a dose level of 2000 mg/kg body weight of 5 male and 5 female of Sprague Dawley rats.
The observation period following treatment lasted for 14 days. Symptoms were recorded twice every day (in the morning and in the afternoon) on weekends and public holidays, only once. During this time the animals were weighed weekly. At the end of the observation period the animals were killed by carbone dioxide asphyxiation, dissected and examined for macroscopically visible changes.
The acute dermal toxicity testing of Reaktiv-Orange DYPR 934 in the rat yielded a median lethal dose (LD50) above 2000 mg/kg body weight in both male of female animals. After administration of 2000 mg/kg body weight neither death nor symptoms occurred. The skins of eight animals show orange discolorations up to day seven of the study. With exception of one female, all animals exhibited body weight gain throughout the study. The animals killed at the end of the observation period showed no macroscopically visible changes. The dermal LD50 value was considered in conjunction with the observed toxic effects and the necropsy findings. Based on the results obtained in the study the median lethal value (LD50) of Reaktiv-Orange DYPR 934 for the male and female rat is greater than 2000 mg/kg body weight.
Results Synopsis and test report:
Species
Strain
Origin
Sex of animals dosed
Tabulation of response data by dose level
LD50 Value
Findings
Sprague Dawley rats
HSD: Sprague Dawley SD
Harlan Winkelmann
Gartenstr. 27, 33178 Borchen
(SPF breeding colony)
Male and female
No animals died during the test.
>2000 mg/kg body weight
The animals killed at the end of the observation period showed no macroscopically visible changes.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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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