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EC number: 230-049-5 | CAS number: 6925-69-5
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Additional toxicological data

Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- 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:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- The objective of this acute dermal toxicity study was to assess the toxicological profile of the test item on application as a single semi-occlusive dermal application to rats.
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- 12H-phthaloperin-12-one
- EC Number:
- 230-049-5
- EC Name:
- 12H-phthaloperin-12-one
- Cas Number:
- 6925-69-5
- Molecular formula:
- C18H10N2O
- IUPAC Name:
- 12H-phthaloperin-12-one
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material : 12H-phthaloperin-12-one
- Common name : C.I. Solvent Orange 60
- Molecular formula : C18H10N2O
- Molecular weight : 270.29 g/mol
- Smiles notation : O=C1N2c3c4c(cccc4N=C2c2ccccc12)ccc3
- InChl : 1S/C18H10N2O/c21-18-13-8-2-1-7-12(13)17-19-14-9-3-5-11-6-4-10-15(16(11)14)20(17)18/h1-10H
- Substance type : Organic
- Physical state : Solid
Constituent 1
- Specific details on test material used for the study:
- - Purity as per Certificate of Analysis:97%
- Lot No.:20120720
- Manufactured date:DEC-2013
- pH:4.69 at 26.8°C
- Density:1.176 g/cm3 at 27°C
- Storage conditions:Ambient (+15 to +25°C)
- SAFETY PRECAUTIONS: Gloves, cap and face mask were used in addition to protective body garments and shoes, to ensure adequate personal health and safety and to avoid inhalation and skin contact with the test item.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Geniron Biolabs Pvt. Ltd. Bengaluru
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 10 to 12 weeks
- Weight at study initiation: Females: 235.18 to 238.33 g
- Identification:By rat accession number. Identification of individual rats is by cage card and crystal violet colour body markings. The temporary body marking during acclimatization period was done with crystal violet. The rat accession numbers were allotted during the course of the study and was included in raw data and reported.
- Housing: Animals were housed individually in standard polysulfone cages (Size: L 425 x B 266 x H 185 mm), with stainless steel top grill. Additionally, polycarbonate rat huts were placed inside the cage as enrichment objects and were changed along with the cage once a week. Bedding: Steam sterilized corn cob was used and changed once a week along with the cage.
- Diet (e.g. ad libitum): Hypro Rat & Mice pellet feed, ad libitum
- Water (e.g. ad libitum): Deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier, ad libitum
- Acclimation period: The rats were acclimatized for six, eight, twelve and fourteen days before treatment for dose range finding and main study respectively under standard laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 24°C
- Humidity (%): 65 to 67%
- Air changes (per hr): air conditioned with adequate fresh air supply (12.4 air changes/hour)
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark cycle
IN-LIFE DATES: From: 03 July 2018 To: 09 July 2018
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: clipped skin of dorsolateral thoracic surface
- % coverage: 10% of the body surface
- Type of wrap if used: The applied area was covered with cotton gauze (size: Females: 8 x 5 cm of 6 ply) and it was secured in position by adhesive tape wound around the torso.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed and the applied area was washed with deionized water and wiped dry using clean towel.
- Time after start of exposure:24 hours
-Preparation of test site for application
Approximately 24 hours before treatment, the hair on the dorsolateral thoracic surface of the skin was clipped (approximately 10 x 8 cm) with an electric clipper Care was taken to avoid abrading the skin, which could alter its permeability - Duration of exposure:
- 24 hours
- Doses:
- DRF G1 - 200 mg/kg
DRF G2 - 1000 mg/kg
DRF G3 - 2000 mg/kg
Main G3 - 2000 mg/kg - No. of animals per sex per dose:
- DRF G1 - 200 mg/kg - 1
DRF G2 - 1000 mg/kg - 1
DRF G3 - 2000 mg/kg - 1
Main G3 - 2000 mg/kg - 2 - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical examination and pre-terminal deaths - The animals were observed for clinical signs and pre-terminal deaths (mortality) once during first 30 minutes after application, and at hourly intervals for 6 hours after application on the day of treatment (day 1) and once daily during Days 2 to 15. In addition, the treatment site was observed for skin reactions at 24, 48 and 72 hours after removal of test chemical using the Draize criteria. All rats were observed for changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Body weights - Individual body weights of animals were recorded on test days 1(Pre-application), 8 (7 days post application), and 15 (14 days post application).
- Necropsy of survivors performed: yes, at the end of the observation period, all rats were euthanised and exsanguinated under isoflurane anesthesia and subjected to detailed necropsy by an experienced prosector and the findings were recorded.
- Other examinations performed: Microscopic examination was not carried out as no gross pathological changes were observed. - Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no other details available
- Mortality:
- There were no pre-terminal deaths (mortality) observed during the study.
- Clinical signs:
- other: There were no clinical signs observed during the study. There were no skin reactions at the site of application at 24 and 48 hours after test patch removal (as per draize method).
- Gross pathology:
- No abnormality was detected at necropsy.
- Other findings:
- not specified
Any other information on results incl. tables
TABLE 1. Individual body weight, body weight changes and pre-terminal deaths
Group and Dose (mg/kg body weight) |
Rat No. |
S e x |
Body weight (g) |
Pre-terminal deaths |
||||
Initial (Day 1 - at treatment) |
8th day |
Weight change (day 8 – Initial) |
15th day |
Weight change (day 15 – Initial) |
||||
G1 and 200 DRF |
Rw283 |
F |
235.18 |
242.68 |
7.50 |
248.19 |
13.01 |
0 |
G2 and 1000 DRF |
Rw284 |
F |
238.33 |
245.45 |
7.12 |
251.67 |
13.34 |
0 |
G3 and 2000 DRF |
Rw285 |
F |
238.16 |
244.73 |
6.57 |
249.14 |
10.98 |
0 |
G3 and 2000 Main study |
Rw286 |
F |
230.34 |
236.59 |
6.25 |
241.08 |
10.74 |
0 |
Rw287 |
F |
234.62 |
242.93 |
8.31 |
247.63 |
13.01 |
0 |
DRF: Dose Range Finding F: Female
APPENDIX 1. Individual test item application, clinical signs, skin reactionand necropsy findings
Dose range finding study
Group & Dose (mg/kg body weight) |
Date and time of application |
Rat Number |
S e x |
Initial Bwt (g) |
Quantity (mL) applied |
Observations and skin reaction |
||||||||||||||||
Days |
||||||||||||||||||||||
1 |
2 |
3 |
4 |
5 |
||||||||||||||||||
30 min |
1 h # |
2 h # |
3 h # |
4 h # |
5 h # |
6 h # |
* |
Er @ |
Ed @ |
* |
Er @ |
Ed @ |
* |
Er @ |
Ed @ |
|||||||
G1 and 200 DRF |
11 April 2018 and 10.55 AM |
Rm8907 |
F |
223.58 |
0.04 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
0 |
0 |
N |
0 |
0 |
N |
0 |
0 |
Group & Dose (mg/kg body weight) |
Rat Number |
S e x |
Observation |
Necropsy findings |
|||||||||
Days |
|||||||||||||
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
||||
G1 and 200 DRF |
Rm8907 |
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
F: Female N: Normal h: hour min: minutes NAD: No abnormality detected Er: Erythema Ed: Edema
Score 0: No Erythema / Edema
*: Clinical signs; @: Skin scoring as per Draize method (approximately 24, 48 and 72 hours) after test patch removal
APPENDIX 2 contd. Individual test item application, clinical signs, skin reaction and necropsy findings
Dose range finding study
Group & Dose (mg/kg body weight) |
Date and time of application |
Rat Number |
S e x |
Initial Bwt (g) |
Quantity (mg) applied |
Observations and skin reaction |
|||||||||||||
Days |
|||||||||||||||||||
1 |
2 |
3 |
4 |
||||||||||||||||
30 min |
1 h |
2 h |
3 h |
4 h |
5 h |
6 h |
* |
Er @ |
Ed @ |
* |
Er @ |
Ed@ |
|||||||
G1- DRF and 200
|
03 July 2018 and 11.36 AM |
Rw283 |
F |
235.18 |
47 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
0 |
0 |
N |
0 |
0 |
Group & Dose (mg/kg body weight) |
Animal Number |
S e x |
Observation/ Days |
Necropsy findings |
||||||||||||||||||||||||||||||
5 |
|
|||||||||||||||||||||||||||||||||
* |
Er @ |
Ed @ |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
||||||||||||||||||||||
G1- DRF and 200
|
Rw283 |
F |
N |
0 |
0 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
F: Female N: Normal h: hour min: minutes NAD: No abnormality detected Er: Erythema Ed: Edema
Score 0: No Erythema / Edema
*: Clinical signs; @: Skin scoring as per Draize method (approximately 24, 48 and 72 hours) after test patch removal
APPENDIX 2 contd. Individual test item application, clinical signs, skin reaction and necropsy findings
Dose range finding study
Group & Dose (mg/kg body weight) |
Date and time of application |
Rat Number |
S e x |
Initial Bwt (g) |
Quantity (mg) applied |
Observations and skin reaction |
|||||||||||||
Days |
|||||||||||||||||||
1 |
2 |
3 |
4 |
||||||||||||||||
30 min |
1 h |
2 h |
3 h |
4 h |
5 h |
6 h |
* |
Er @ |
Ed @ |
* |
Er @ |
Ed @ |
|||||||
G2- DRF and 1000
|
05 July 2018 and 11.56 AM |
Rw284 |
F |
238.33 |
238 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
0 |
0 |
N |
0 |
0 |
Group & Dose (mg/kg body weight) |
Animal Number |
S e x |
Observation/ Days |
Necropsy findings |
||||||||||||||||||||||||||||||
5 |
|
|||||||||||||||||||||||||||||||||
* |
Er @ |
Ed @ |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
||||||||||||||||||||||
G2- DRF and 1000
|
Rw284 |
F |
N |
0 |
0 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
F: Female N: Normal h: hour min: minutes NAD: No abnormality detected Er: Erythema Ed: Edema
Score 0: No Erythema / Edema
*: Clinical signs; @: Skin scoring as per Draize method (approximately 24, 48 and 72 hours) after test patch removal
APPENDIX 2 contd. Individual test item application, clinical signs, skin reaction and necropsy findings
Main study
Group & Dose (mg/kg body weight) |
Date and time of application |
Rat Number |
S e x |
Initial Bwt (g) |
Quantity (mg) applied |
Observations and skin reaction |
|||||||||||||
Days |
|||||||||||||||||||
1 |
2 |
3 |
4 |
||||||||||||||||
30 min |
1 h |
2 h |
3 h |
4 h |
5 h |
6 h |
* |
Er @ |
Ed @ |
* |
Er @ |
Ed @ |
|||||||
G3- Main and 2000
|
12 July 2018 and 11.41 AM to 11.42 AM |
Rw286 |
F |
230.34 |
461 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
0 |
0 |
N |
0 |
0 |
Rw287 |
F |
234.62 |
469 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
0 |
0 |
N |
0 |
0 |
Group & Dose (mg/kg body weight) |
Animal Number |
S e x |
Observation/ Days |
Necropsy findings |
||||||||||||||||||||||||||||||
5 |
|
|||||||||||||||||||||||||||||||||
* |
Er @ |
Ed @ |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
||||||||||||||||||||||
G3- Main and 2000
|
Rw286 |
F |
N |
0 |
0 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
||||||||||||||||||
Rw287 |
F |
N |
0 |
0 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
F: Female N: Normal h: hour min: minutes NAD: No abnormality detected Er: Erythema Ed: Edema
Score 0: No Erythema / Edema
*: Clinical signs; @: Skin scoring as per Draize method (approximately 24, 48 and 72 hours) after test patch removal
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- Acute dermal toxicity study was conducted in order assess the toxicological profile of the test item on wistar rats. Based on the results, The LD50 of test chemical was determined to be >2000 mg/kg ,Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.
- Executive summary:
The acute dermal toxicity of test chemical in Wistar rats was tested with 200 (G1-DRF), 1000 (G2-DRF) and 2000 (G3-DRF) mg/kg with 1 female each for the dose range finding study and 2 female for main study (G3).Based on the individual body weight, the test item at the dose of 200, 1000 and 2000 mg/kg body weight was weighed on an aluminum foil and made as a paste in Milli-Q water and applied directly to the clipped skin of the animal to cover about 10% of the body surface of the animal (semi-occlusive). The area of application was covered with cotton gauze (size: Females: 8 x 5 cm of 6 ply) and it was secured in position by adhesive tape wound around the torso. The test item contact period with the skin was for 24 hours.After the 24 hours contact period, the dressing was removed and the applied area was washed with deionized water and wiped dry using clean towels. All the rats were observed for clinical signs of toxicity and mortality for 14 days post application. In addition, the treatment site was observed at 24, 48 and 72 hours after removal of test item using the Draize criteria. There were no clinical signs of toxicity and mortality. There was no skin reaction observed at the site of application of test item. Body weights were measured on Days 1, 8 and 15 and growth was unaffected by test item. At the end of observation period (Day 15), all animals were euthanized and subjected to necropsy, and there were no gross lesions noted at the necropsy.Based on the present study results, the acute dermal LD50of test chemical is greater than 2000 mg/kg body weight in female Wistar rats.Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.
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