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EC number: 433-180-8 | CAS number: -
- Life Cycle description
- Uses advised against
- 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
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
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- Toxicity to other aquatic organisms
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
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- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-01-26 to 1999-02-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in compliance with EEC-Guideline B1 and OECD Guidelines for testing chemicals 401 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 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- Standard acute method
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- 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 = 206g (=100%)
S =± 6.1 g
Min= 198 g (-3.9%)
Max = 212 g (+2.9%)
n = 5
Female animals Mean = 179 g (=100%)
S =± 5.4 g
Min= 172 g (-3.9%)
Max = 184 g (+2.8%)
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 4) on soft wood granulate in groups of 5 animals
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
Withdrawal of food: from about 16 hours before to 3-4 hours after treatment
Water: tap water in plastic bottles, ad libitum
Animal identification: fur marking with KmnO4
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Deionized water
- Details on oral exposure:
VEHICLE
- Concentration in vehicle and amount of vehicle: The animals received the compound as a 20 % solution in deionized water, the administration volume being 10 mL/kg body weight
-Oral gavage to fasted animals:
2000 mg/kg bodyweight (base on a dose range finding study)- Doses:
- 2000 mg/kg solution in deionized water (10 mL/kg) bw.
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 14 days (The observation period following treatment lasted for 14 days)
Frequency of observations and weighing: Symptoms 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
Necropsy of survivors performed: yes
Clinicals observations: the following clinical signs were observed after the administration of Reaktiv-Orange DYPR 934:
Squatting posture, stilted gate, irregular respiration, diarrhea and orange discolored feces.
Body weight: development of body weight was not impaired
Lethality: no death occurred during the whole study
Results and discussion
- Preliminary study:
- No lethality occurred after application of 2000 mg/kg body weight:
Besides unspecific symptoms:
Impairments of mobility and respiration. Additionally diarrhea and orange discolored feces were observed.
Clinical signs: squatting posture, stilted gait, irregular respiration, diarrhea and orange discolored feces.
At day two of the study the irritations were disappeared.
Development of body weight was not impaired
Autopsy findings: no macroscopically visible changes
No symptoms were observed after administration of 500 mg/kg body weight
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 deaths occurred during the whole study. The following clinical signs were observed after the administration of the test substance: squatting posture, stilted gait, irregular respiration, diarrhea and orange discolored feces. At day two of the study t
- Gross pathology:
- INDIVIDUAL GROSS PATHOLOGY OBSERVATIONS
Group I: Dose: 2000 mg/kg body weight Sex: female
Animal number Mode of Death Death
Day (Week) Observation(s)
6 SCHEDULED KILL: FINAL 15 (3) No visible Lesions
7 SCHEDULED KILL: FINAL 15 (3) No visible Lesions
8 SCHEDULED KILL: FINAL 15 (3) No visible Lesions
9 SCHEDULED KILL: FINAL 15 (3) No visible Lesions
10 SCHEDULED KILL: FINAL 15 (3) No visible Lesions
The animals killed at the end of the observation period showed no macroscopically visible changes. - Other findings:
- - Other observations: No deaths occurred during the whole study.
Any other information on results incl. tables
Dose Range finding study
Test substance: Reaktiv-Orange DYPR 934
Vehicle: dionized water
Concentration: 20%
Dose Mg/kg Body weight |
Sex (m/f) |
Date of administration |
Body weight (g) Days after administration 0 7 14 |
Lethality
Time bw P.a [g] |
|
2000 |
m f |
1999-01-26 |
214 268 295 |
- |
- |
1999-01-26 |
170 220 220 |
- |
- |
||
1000 |
m f |
1999-01-26 |
198 243 263 |
- |
- |
1000 |
1999-01-26 |
158 195 203 |
- |
- |
|
500 |
m f |
1999-01-26 |
210 267 292 |
- |
- |
500 |
1999-01-26 |
172 202 217 |
- |
- |
Comprehensive description of clinicals signs:
No deaths occurred during the whole study.
The following clinical signs were observed after the administration of the test substance in the 1000 and 2000 mg/kg bw. group: squatting posture, stilted gait, diarrhea and orange discolored feces. At day two of the study the irritations were disappeared. Development of body weight was not impaired.
No symptoms was observed after administration of 500 mg/kg body weight.
Comprehensive description of the macroscopic findings:
The animals killed at the end of the observation showed no macroscopically visible changes.
No lethality occurred after application of 2000 mg/kg body weight.
Table I: Bodyweights-Individual Bodyweights Study: 99. 0012-Acute Oral Toxicity with Reaktiv-Orange DYPR 934 in Rats |
|
|||||||||
Table 1: Bodyweights: Individual Bodyweights |
|
|||||||||
Day numbers relative to Start Date |
|
|||||||||
Group Sex |
Animal Number |
1 |
6 |
15 |
|
|||||
1m |
1 |
212 |
265* |
287 |
|
|||||
|
2 |
206 |
261* |
269 |
|
|||||
|
3 |
211 |
265* |
303 |
|
|||||
|
4 |
201 |
260* |
287 |
|
|||||
|
5 |
198 |
258* |
296 |
|
|||||
|
Mean |
205.6 |
261.8 |
292.4 |
|
|||||
|
S.D. |
6.1 |
3.1 |
7.0 |
|
|||||
|
N |
5 |
5 |
5 |
|
|||||
1 f |
6 |
184 |
208 |
216 |
|
|||||
|
7 |
181 |
207 |
215 |
|
|||||
|
8 |
172 |
197 |
207 |
|
|||||
|
9 |
183 |
210 |
216 |
|
|||||
|
10 |
174 |
203 |
210 |
|
|||||
|
Mean |
178.6 |
205.0 |
212.8 |
|
|||||
|
S.D. |
5.4 |
5.1 |
4.1 |
|
|||||
|
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 |
1 |
8 |
Out of range |
< |
|||||
|
2 |
8 |
Out of range |
< |
||||||
|
3 |
8 |
Out of range |
< |
||||||
|
4 |
8 |
Out of range |
< |
||||||
|
5 |
8 |
Out of range |
< |
||||||
Marker= implies value excluded from means |
||||||||||
Day numbers relative to Start Date |
||||||||||
Table 2: Bodyweights Gains- Individual Bodyweight Gains |
||||||||||
|
Group Sex |
Animal Number |
From
To |
1
8 |
8
15 |
|||||
|
1m |
1 |
|
53* |
22* |
|||||
|
|
2 |
|
55* |
28* |
|||||
|
|
3 |
|
54* |
38* |
|||||
|
|
4 |
|
59* |
27* |
|||||
|
|
5 |
|
50* |
38* |
|||||
|
|
|
Mean |
56.2 |
30.6 |
|||||
|
|
|
S.D. |
3.1 |
7.1 |
|||||
|
|
|
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 |
|
24 |
8 |
|||||
|
|
7 |
|
26 |
8 |
|||||
|
|
8 |
|
25 |
10 |
|||||
|
|
9 |
|
27 |
6 |
|||||
|
|
10 |
|
29 |
7 |
|||||
|
|
|
Mean |
26.2 |
7.8 |
|||||
|
|
|
S.D. |
1.9 |
1.5 |
|||||
|
|
|
N |
5 |
5 |
|||||
Clinical Observations- Table 3: Clinical signs by Animal |
||||||||
Day numbers relative to Start Date |
||||||||
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 |
- |
- |
- |
- |
|
|
Gait stilted |
- |
- |
X |
X |
X |
X |
|
Squatting posture |
- |
- |
X |
X |
X |
X |
|
|
Diarrhea |
- |
- |
- |
- |
X |
X |
|
|
Feces discolored |
- |
- |
- |
o |
o |
o |
|
|
Irregular respiration |
- |
- |
- |
- |
- |
- |
|
|
2
|
No Abnormalities Detected |
X |
X |
X |
- |
- |
- |
|
Gait stilted |
- |
- |
- |
X |
X |
- |
|
|
Squatting posture |
- |
- |
- |
X |
X |
- |
|
|
Feces discolored |
- |
- |
- |
- |
o |
o |
|
|
Irregular respiration |
- |
- |
- |
- |
X |
- |
|
|
|
|
|
|
|
|
|
|
|
3
|
No Abnormalities Detected |
X |
X |
- |
- |
- |
- |
|
Gait stilted |
- |
- |
X |
X |
X |
X |
|
|
Squatting posture |
- |
- |
X |
X |
X |
X |
|
|
Feces discolored |
- |
- |
- |
- |
o |
o |
|
|
Irregular respiration |
- |
- |
- |
- |
X |
X |
|
|
|
|
|
|
|
|
|
|
|
4
|
No Abnormalities Detected |
X |
X |
- |
- |
- |
- |
|
Gait stilted |
- |
- |
X |
X |
X |
- |
|
|
Squatting posture |
- |
- |
X |
X |
X |
- |
|
|
Feces discolored |
- |
- |
- |
- |
0 |
0 |
|
5 |
No Abnormalities Detected |
X |
X |
- |
- |
- |
- |
|
|
Gait stilted |
- |
- |
X |
X |
X |
X |
|
|
|
Squatting posture |
- |
- |
X |
X |
X |
X |
|
Feces discolored |
- |
- |
- |
o |
o |
0 |
|
|
|
X |
|
|
|
|
|
|
|
Diarrhea |
X |
X |
X |
X |
X |
X |
|
|
|
X |
X |
X |
X |
X |
X |
|
|
Irregular respiration |
X |
X |
X |
X |
X |
X |
|
1f |
6 |
No Abnormalities Detected |
X |
X |
- |
- |
- |
- |
|
Gait stilted |
- |
- |
X |
X |
X |
X |
|
|
Squatting posture |
- |
- |
X |
X |
X |
X |
|
|
Diarrhea |
- |
- |
- |
X |
X |
X |
|
|
Feces discolored |
- |
- |
- |
o |
o |
o |
|
|
Irregular respiration |
- |
- |
- |
- |
X |
X |
|
|
7 |
No Abnormalities Detected |
X |
- |
- |
|
- |
- |
|
Gait stilted |
- |
X |
X |
X |
X |
X |
|
|
Squatting posture |
- |
X |
X |
X |
X |
X |
|
|
Diarrhea |
- |
- |
X |
X |
X |
X |
|
|
Feces discolored |
- |
- |
o |
o |
o |
o |
|
|
|
|
|
|
|
|
|
|
|
8 |
No Abnormalities Detected |
X |
- |
- |
- |
- |
- |
|
Gait stilted |
- |
X |
X |
X |
X |
X |
|
|
Squatting posture |
- |
X |
X |
X |
X |
X |
|
|
Diarrhea |
- |
- |
X |
X |
X |
X |
|
|
Feces discolored |
- |
- |
o |
o |
o |
o |
|
|
Irregular respiration |
- |
- |
- |
- |
X |
X |
|
|
9 |
No Abnormalities Detected |
X |
X |
- |
- |
- |
- |
|
Gait stilted |
- |
- |
X |
X |
X |
X |
|
|
Squatting posture |
- |
- |
X |
X |
X |
X |
|
|
Diarrhea |
- |
- |
- |
X |
X |
X |
|
|
Feces discolored |
- |
- |
- |
o |
o |
o |
|
|
10 |
No Abnormalities Detected |
X |
- |
- |
- |
- |
- |
|
Gait stilted |
- |
X |
X |
X |
X |
X |
|
|
Squatting posture |
- |
X |
X |
X |
X |
X |
|
|
Diarrhea |
- |
- |
X |
X |
X |
X |
|
|
Feces discolored |
- |
- |
o |
o |
o |
o |
|
|
Irregular respiration |
- |
- |
- |
- |
X |
- |
|
X= Present O= orange Nominal Dose: Group I -2000mg/ kg bodyweight -result to left has an associated comment or marker |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on results obtained in this study the median lethal dose value (LD50) of Reaktiv Orange DYPR 934 for the male and female rat is greater than 2000 mg/kg body weight.
- Executive summary:
In an acute toxicity oral study (conducted in accordance with the OECD Guideline), Reaktiv-Orange DYPR 934 was administrated by gavage to 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 oral 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. No lethality occurred after application of 2000 mg/kg body weight. Besides unspecific symptoms the animals showed impairments of mobility and respiration. Additionally the diarrhea and orange discolored faces were observed. At day two of the study the irritations were disappeared. Development of body weight was not impaired. The animals killed at the end of the observation period showed no macroscopically visible changes.
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.
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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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