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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 29 September 2021 to 30 September 2021
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)
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Reference substance name:
Fatty acids, palm-oil (C16-C18), Me esters, chlorinated (35-45 % w/w)
EC Number:
953-553-3
Cas Number:
95009-45-3
Molecular formula:
It cannot be provided.
IUPAC Name:
Fatty acids, palm-oil (C16-C18), Me esters, chlorinated (35-45 % w/w)
Test material form:
liquid
Details on test material:
Batch number: SV210602R4001

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
Animals were housed under standard laboratory conditions, in an environmentally monitored air-conditioned room with adequate fresh air supply (12 to 15 air changes per hour), room temperature 19.6°C to 22.9°C and relative humidity 47% to 65%, with 12 hours fluorescent light and 12 hours dark cycle. The temperature and relative humidity were recorded once daily.

Administration / exposure

Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Topically application
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
two female rats
Control animals:
no
Details on study design:
Two animals were administered with the same dose level of 2000 mg/kg body weight. Exposure time 24 hours. All the animals were observed for clinical signs of toxicity and mortality at
20 to 30 mins, 1 hr (±10 mins), 2 hrs (±10 mins), 4 hrs (±10 mins) 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
treatment site was observed approximately at 24, 48 and 72 hours after removal of test
patch using the Draize scoring system.

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 mortality
Clinical signs:
other:
Body weight:
other body weight observations
Remarks:
No changes in body weight.
Gross pathology:
No gross pathology

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Under the experimental conditions employed and based on the above results, it is
concluded that the acute dermal median lethal dose (LD50) of test item, ESTERI
METILICI ACIDI GRASSI DA OLIO ESSEBIOCHLOR45 in Sprague Dawley rats
is >2000 mg/kg body weight and classified as “Category 5 / Unclassified (2000 <
ATE ≤ 5000 mg/kg body weight)” according to the Globally Harmonized System
(GHS) of Classification.
Executive summary:

The test item, ESTERI METILICI ACIDI GRASSI DA OLIO ESSEBIOCHLOR45 was evaluated for Acute Dermal Toxicity in Sprague Dawley Rats. The study was performed in two phases i.e. range finding study and main study. Range finding study was performed with three female rats (one rat per step) and main study was performed with two female rats. On the day before the application of the test item, fur on the dorso-lateral area of the trunk of the animals was removed by clipping closely with an electric hair clipper and care was taken to avoid abrading the skin. The required quantity of the test item was applied as uniform film over an area of approximately 10% of the total body surface. The test item was held on to the applied surface by covering with cotton gauze dressing and wrapped with non-irritating adhesive tape. Finally the application site was wrapped with semi-occlusive dressing using crepe bandage. The contact period of test item was 24 hours. At the end of the contact period, the residual test item was washed using distilled water and dried with absorbent cotton. As there was no information on the test item, a starting dose of 200 mg/kg body weight was selected from the fixed dose levels of 50, 200, 1000 and 2000 mg/kg body weight. No clinical signs and mortality was observed at the dose level of 200 mg/kg body weight in range finding study. Further, one animal was dosed at 1000 mg/kg body weight. No clinical signs and mortality was observed at the dose level of 1000 mg/kg body weight in range finding study. Next one animal was dosed at 2000 mg/kg body weight. No clinical signs and mortality was observed at the dose level of 2000 mg/kg body weight in range finding study. Hence, during main study, two animals were administered with the same dose level of 2000 mg/kg body weight. No clinical signs and mortality was observed at the dose level of 2000 mg/kg body weight. No mortality was observed at any of the dosed steps. Hence, no further testing was carried out. All the animals were observed for clinical signs of toxicity and mortality at 20 to 30 mins, 1 hr (±10 mins), 2 hrs (±10 mins), 4 hrs (±10 mins) 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 treatment site was observed approximately at 24, 48 and 72 hours after removal of test patch using the Draize scoring system. The body weights were recorded at receipt, on day 1 before test item application, on days 8 and 15. At the end of observation period, all the animals were sacrificed under carbon dioxide asphyxiation and subjected to necropsy and detailed gross pathological examination. No mortality and clinical signs were observed. No skin reactions were observed in the treatment sites at 24, 48 and 72 hours after removal of test item using draize method. No treatment related changes in body weight and percent change in body weight with respect to day 1 were noted. Normal increase in body weights were noted during the observation period. No treatment related gross pathological changes were noted in any of the dosed animals (range finding study and main study) during necropsy.