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EC number: 308-067-0 | CAS number: 97862-23-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- 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
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- Acute Dermal Toxicity Study of test chemical in Wistar albino rats
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 9,10-Anthracenedione, 1, 4-Diamino-N-N’-Bis(4-C7-17-Branched Alkyl phenyl) Derives
- Cas Number:
- 97862-23-2
- IUPAC Name:
- 9,10-Anthracenedione, 1, 4-Diamino-N-N’-Bis(4-C7-17-Branched Alkyl phenyl) Derives
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source :Institute for Industrial Research and Toxicology Ghaziabad,
Age: 8 to 10 weeks
Sex: Male and female
Body weight range : 200±20g
Identification : By cage tag and corresponding colour body marking
No. of animals per dose group : 10 (5male & 5 female)
No. of dose groups : Group-I: 2000 mg/kg b.wt (limit test), Group-II: 2000 mg/kg b.wt (confirmatory test)
Acclimatization : The healthy wistar albino rats selected for study acclimatized to standard laboratory condition for period of one week under close Veterinary supervision.
Randomization : After acclimation and Veterinary examination all the animals randomly divided into two groups and each group having five male and five female rats.
Nutritional conditions : Animals were fasted overnight prior to test and food was offered three hours after dosing.
Environmental conditions : Air conditioned rooms with 10-15 air changes per hour, temperature between 22-250C, relative humidity 40-60% and illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.
Accommodation : Groups of three animals of same sex in polypropylene cages with stainless steel grill top, facilities for food and water bottle, and bedding of clean paddy husk.
Diet : Pelleted feed supplied by Pranav agro Industries Ltd., B7/6 Ramesh Nagar, Delhi, India
Water : Fresh and clean water filtered through ‘Aqua Guard on line water filter’, was kept in glass bottles Ad libitum
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back skin of total body surface area
- % coverage: Approximate 10 percent
- Type of wrap if used: Impervious dressing were used.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, cleaned with lukewarm water wiping
- Time after start of exposure:24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg b.wt
- Concentration (if solution):
- Constant volume or concentration used: yes
- For solids, paste formed: no - Duration of exposure:
- :24 hours
- Doses:
- 2000 mg/kg b.wt
- No. of animals per sex per dose:
- Total: 20
2000 mg/kg b.wt (limit test): 5 male & 5 female
2000 mg/kg b.wt (confirmatory test): 5 male & 5 female - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Animals were observed for first 4 hours and thereafter for every 1 hrs interval for 24 hrs after dosing and twice a day for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed:Mortality, clinical signs, body weight and gross pathology were examined.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality observed
- Mortality:
- No mortality at 2000 mg/kg b.wt in wistar albino rats were observed throughout the period of observation14 days.
- Clinical signs:
- No clinical signs of toxicity were observed in entire the observation period of 14 days.
- Body weight:
- Normal gain in body weight was observed on day 7th and 14th (post treatment) as compared to day 0th (pre treatment).
- Gross pathology:
- No significant gross pathological changes related to compound toxicity were observed.
Any other information on results incl. tables
SUMMARY OF BODY WEIGHT (GM
Group |
Animal ID |
Day 0 |
Day 7 |
% Gain/loss |
Day 14 |
% Gain/loss |
Group-I 2000 mg/kg b. wt
|
20172-1 |
201.3 |
207.1 |
2.88 |
213.4 |
6.01 |
20172-2 |
200.2 |
205.3 |
2.54 |
210.3 |
5.04 |
|
20172-3 |
200.5 |
206.4 |
2.94 |
213.2 |
6.33 |
|
20172-4 |
203.4 |
210.3 |
3.39 |
212.4 |
4.42 |
|
20172-5 |
199.6 |
206.7 |
3.56 |
210.5 |
5.46 |
|
20172-6 |
206.4 |
210.4 |
1.93 |
215.3 |
4.31 |
|
20172-7 |
202.7 |
207.4 |
2.31 |
212.1 |
4.63 |
|
20172-8 |
207.5 |
212.4 |
2.36 |
217.3 |
4.72 |
|
20172-9 |
203.4 |
209.3 |
2.90 |
212.4 |
4.42 |
|
20172-10 |
202.1 |
205.5 |
1.68 |
212.4 |
5.09 |
|
Group-II 2000 mg/kg b. wt |
20172-11 |
198.4 |
209.2 |
5.44 |
208.1 |
4.88 |
20172-12 |
205.5 |
211.3 |
2.82 |
216.6 |
5.40 |
|
20172-13 |
206.4 |
212.2 |
2.81 |
217.4 |
5.32 |
|
20172-14 |
202.4 |
207.4 |
2.47 |
213.4 |
5.43 |
|
20172-15 |
203.5 |
207.1 |
1.76 |
213.1 |
4.71 |
|
20172-16 |
207.7 |
214.3 |
3.17 |
217.4 |
4.67 |
|
20172-17 |
200.4 |
207.3 |
3.44 |
209.2 |
4.39 |
|
20172-18 |
197.4 |
202.7 |
2.68 |
210.2 |
6.48 |
|
20172-19 |
205.3 |
210.4 |
2.48 |
216.1 |
5.26 |
|
20172-20 |
206.6 |
211.4 |
2.32 |
218.4 |
5.71 |
CLINICAL SIGNS AND MORTALITY
Group: I Limit test Dose: 2000 mg/kg b.wt
Parameters |
Incidence of Clinical Signs Observed after Dosing on |
Mortality |
|||||||||||||||||||
Day 0 |
DAY |
||||||||||||||||||||
Min |
Hour |
||||||||||||||||||||
30 |
1 |
2 |
4 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
Total |
% |
|
Mortality (total) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/10 |
0 |
Clinical Signs- Local |
|
||||||||||||||||||||
Redness |
- |
- |
- |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Pain |
- |
- |
- |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Swelling |
- |
- |
- |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Systemic signs |
|||||||||||||||||||||
Clinical signs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- =Observed after 24 hrs
0 = No clinical signs
+ = Mild
++ = Moderate
+++ = High
++++ = Severe
CLINICAL SIGNS AND MORTALITY
Group: II Confirmatory test 2000 mg/kg b.wt
Parameters |
Incidence of Clinical Signs Observed after Dosing on |
Mortality |
|||||||||||||||||||
Day 0 |
DAY |
||||||||||||||||||||
Min |
Hour |
||||||||||||||||||||
30 |
1 |
2 |
4 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
Total |
% |
|
Mortality (total) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/10 |
0 |
Clinical Signs- Local |
|
||||||||||||||||||||
Redness |
- |
- |
- |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Pain |
- |
- |
- |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Swelling |
- |
- |
- |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Systemic signs |
|||||||||||||||||||||
Clinical signs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- =Observed after 24 hrs
0 = No clinical signs
+ = Mild
++ = Moderate
+++ = High
++++ = Severe
SUMMARY OF NECROPSY FINDINGS
S. No. |
Fate
|
Wistar albino rats |
|
Dose (mg/kg b. wt) |
|||
2000 (limit test) |
2000 (confirmatory test) |
||
1 |
Terminal sacrifice |
10/10 |
10/10 |
2 |
Found Dead |
0/10 |
0/10 |
3 |
Abnormalities detected |
0/10 |
0/10 |
INDIVIDUAL ANIMAL FATE & NECROPSY FINDINGS
Group-I (limit test) 2000 mg/kg b.wt.
Animal ID |
Fate |
Time |
Gross Findings |
20172-1 |
TS |
Day 14 |
NAD |
20172-2 |
TS |
Day 14 |
NAD |
20172-3 |
TS |
Day 14 |
NAD |
20172-4 |
TS |
Day 14 |
NAD |
20172-5 |
TS |
Day 14 |
NAD |
20172-6 |
TS |
Day 14 |
NAD |
20172-7 |
TS |
Day 14 |
NAD |
20172-8 |
TS |
Day 14 |
NAD |
20172-9 |
TS |
Day 14 |
NAD |
20172-10 |
TS |
Day 14 |
NAD |
Day 0 is the day of dose administration.
TS- Terminal Sacrifice
NAD- No abnormality Detected
INDIVIDUAL ANIMAL FATE & NECROPSY FINDING
Group: II(confirmatory test) Dose: 2000 mg/kg b.wt.
Animal ID |
Fate |
Time |
Gross Findings |
20172-11 |
TS |
Day 14 |
NAD |
20172-12 |
TS |
Day 14 |
NAD |
20172-13 |
TS |
Day 14 |
NAD |
20172-14 |
TS |
Day 14 |
NAD |
20172-15 |
TS |
Day 14 |
NAD |
20172-16 |
TS |
Day 14 |
NAD |
20172-17 |
TS |
Day 14 |
NAD |
20172-18 |
TS |
Day 14 |
NAD |
20172-19 |
TS |
Day 14 |
NAD |
20172-20 |
TS |
Day 14 |
NAD |
Day 0 is the day of dose administration.
TS- Terminal Sacrifice
NAD- No abnormality Detected
FD-Found dead
FD-Found dead
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- LD50 of test compound was found to be more than 2000 mg/kg b.wt. (>2000 mg/kg b.wt.) when Wistar albino male and female rats.treated dermally.
- Executive summary:
In a acute dermal toxicity study, Wistar albino male and female rats treated with test chemical dermally at 2000 mg/kg b.wt applied uniformly over approximate 10 percent back skin of total body surface area for 24 hrs with an impervious dressing secured in place with an adhesive tape. The animals were then housed individually in cages with a collar around the neck in order to avoid the ingestion of the test compound. After 24 hours, the dressing was removed and the site of application was cleaned with lukewarm water wiping. No mortality at 2000 mg/kg b.wt in wistar albino rats were observed throughout the period of observation14 days. No clinical signs of toxicity were observed in entire the observation period of 14 days. Normal gain in body weight was observed on day 7th and 14th (post treatment) as compared to day 0th (pre treatment). No significant gross pathological changes related to compound toxicity were observed. Therefore, LD50 of test compound was found to be more than 2000 mg/kg b.wt. (>2000 mg/kg b.wt.) when Wistar albino male and female rats treated dermally.
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