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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25.03.2021-19.04-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Extract of fava d'anta, obtained from the fruits of Dimorphandra mollis (Leguminosae) by solvent extraction
EC Number:
953-265-8
Molecular formula:
Not applicable
IUPAC Name:
Extract of fava d'anta, obtained from the fruits of Dimorphandra mollis (Leguminosae) by solvent extraction
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: not specified
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 202.52 g to 224.30 g
- Housing: Maximum of three animals were housed in a standard polypropylene cage (430x285x 150 mm) with stainless steel mesh top grill having facilities for holding pelleted feed and drinking water in water bottle fitted with stainless steel sipper tube. For range finding study animals were housed individually during and after treatment. For main study, during treatment, the animals were housed individually; and after patch removal, animals were housed together. Clean sterilized paddy husk was provided as bedding material. Paper shredding was provided as enrichment.
- Diet: Altromin Maintenance Diet for rats and mice manufactured by Altromin Spezialfutter GmbH & Co. KG was provided ad libitum
- Water: It was provided ad libitum throughout the experimental period. Deep bore-well water passed through Reverse osmosis unit was provided in plastic water bottles with stainless steel sipper tubes.The contaminant analysis test reports for the water are included
- Acclimation period: 5 (200 mg/kg body weight), 7 (1000 mg/kg body weight) and 9 days (2000 mg/kg body weight) for range finding study, and 11 days for the main study animals
- Method of randomisation in assigning animals to test and control groups: Randomization was done during acclimatization period.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.6°C to 22.9°C
- Humidity (%): 47% to 66%
- Air changes (per hr): 12 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light and 12 hours dark cycle

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
Mysore Research Chemical Laboratories, Batch. No 435
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso-lateral of the trunk
- % coverage: 10%
- Type of wrap if used: cotton gauze dressing and non-irritating adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with distilled water and dried with absorbent cotton
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 46.4 to 472.9 mg in Range Finding Study, 431.4 to 435.6 mg in Main Study
- Constant volume or concentration used: yes/no
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit):0.5 mL
- Lot/batch no. (if required): 435
Duration of exposure:
72 hours
Doses:
- 200 mg/kg bw (Range Finding)
- 1000 mg/kg bw (Range Finding)
- 2000 mg/kg bw (Range Finding and Main Study)
No. of animals per sex per dose:
Range Finding: 1 female per dose (3 females in total)
Main Study: 2 females per dose (2000 mg/kg bw)
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All the animals were observed for clinical signs of toxicity and mortality at 20 to 30 mins, 1 hr , 2 hrs , 4 hrs and 6 hrs (±10 mins) on treatment day 1 and thereafter once daily for clinical signs of toxicity and twice daily for mortality during the 14 days observation period. The body weights were recorded at receipt, on day 1 before test item application, on days 8 and 15.
- Necropsy of survivors performed: yes
- Clinical signs including body weight: Observations included changes in skin, fur, eyes and mucous membranes along with changes in respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Individual animal body weights were recorded at receipt, on day 1 before test item application and on days 8 and 15 during the experimental period.
- Other examinations performed: all the animals were subjected to necropsy and a complete gross pathological examination. Histopathological examination was not carried out as there were no gross pathological findings in any of the animals.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No treatment related mortality was observed in both range finding study and main study animals.
Clinical signs:
other: No treatment related clinical signs of toxicity were observed in both range finding study and main study animals.
Gross pathology:
No treatment related gross pathological changes were in both range finding study and main study animals.

Any other information on results incl. tables

Table 1. Clinical signs of toxicity and mortality record


































































































































































Phase of the Experiment



Dose (mg/kg body weight)



Animal No.



Sex



Time of Dosing


(AM)



Clinical Signs of Toxicity and Mortality on Day 1



Clinical Signs of Toxicity and Mortality on days



20-30


mins



1 hr


(±10 mins)



2 hrs


(±10 mins)



4 hrs


(±10 mins)



6 hrs


(±10 mins)



2



3



4



5



6



7



8



9



10



11



12



13



14



15



Range Finding Study



200



Rf3976



F



10:15



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



1000



Rf3977



F



10:17



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



2000



Rf3978



F



10:20



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



Main Study



2000



Rf3979



F



10:32



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



Rf3980



F



10:34



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



 N: Normal; F: Female; mins: minutes; hr/hrs: hour/hours


 


Table 2. Individual animal local skin reactions



















































































Phase of the Experiment



Animal No



Sex



Dose (mg/kg body weight)



Days



3 (24 hours)



4 (48 hours)



5 (72 hours)



ER



ED



ER



ED



ER



ED



Range finding Study



Rf3976



Female 



200



0



0



0



0



0



0



Rf3977



Female 



1000



0



0



0



0



0



0



Rf3978



Female 



2000



0



0



0



0



0



0



Main Study



Rf3979



Female 



2000



0



0



0



0



0



0



Rf3980



Female 



2000



0



0



0



0



0



0



ER: Erythema; ED: Edema; 0: No erythema/edema


 


Table 3. Body weight (g) and percent change in body weight with respect to day 1



















































































































Phase of the Experiment



Dose (mg/kg body weight)



Animal No.



Sex



Quantity


Administered (mg)



Body Weight (g) on Days


 

Percent Change in Body Weight with Respect to Day



1



8



15


 

1 to 8



1 to 15



Range Finding Study



200



Rf3976



F



46.4



231.93



246.12



261.28



 



6.12



12.65



1000



Rf3977



F



232.7



232.68



246.21



260.02



 



5.81



11.75



2000



Rf3978



F



472.9



236.47



249.83



264.21



 



5.65



11.73



Main Study



2000



Rf3979



F



431.4



215.72



230.31



245.20



 



6.76



13.67



Rf3980



F



435.6



217.78



233.14



248.12



7.05



13.93


  

Mean



216.75



231.73



246.66



 



6.91



13.80



±SD



1.46



2.00



2.06



 



0.20



0.19



 



 



                    n



2



 2



2



 



  2



2



F: Female; SD: Standard Deviation; n: number of animals.


 


Table 4. Gross pathology findings



























































Phase of the Experiment



Dose


(mg/kg body weight)



Animal No.



Sex



Fate



Gross Pathology Findings



External



Internal



Range finding Study



200



Rf3976



F



TS



NAD



NAD



1000



Rf3977



F



TS



NAD



NAD



2000



Rf3978



F



TS



NAD



NAD



Main Study



2000



Rf3979



F



TS



NAD



NAD



Rf3980



F



TS



NAD



NAD



NAD: No Abnormality Detected; F: Female; TS: Terminal Sacrifice

Applicant's summary and conclusion

Interpretation of results:
other: Not classified (CLP Regulations EC no. 1272/2008)
Conclusions:
The LD50 value of the test item is >2000 mg/ kg body weight by dermal route in rat.
Executive summary:

The acute dermal toxicity of the test item has been performed in accordance with OECD Test Guideline 402, following GLP. A thin paste of the test item and water was applied to a total of 5 female Sprague-Dawley rats in two differents studies. A range finding study using three female rats was performed using a concentration of 200, 1000 and 2000 mg/kg b.w., respectively. As no clinical signs of toxicity nor mortality were observed at any of these concentrations, the main test was carried out using 2 more female rats at a concentration of 2000 mg/kg b.w. Again, no clinical signs of toxicity nor mortality were observed. No adverse changes were observed in body weight and percent change in body weight with respect to day 1 and no gross pathological changes were observed in any of the studies performed. Therefore, the test item has a LD50 value of >2000 mg/kg b.w. As such, the test item is not classified acccording to CLP Regulations EC no. 1272/2008.