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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 23 - February 6, 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2020
Report date:
2020

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
2017
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
Council Regulation (EC) No. 440/2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Nonanoic acid, mixed diesters, with oxybis[propanol] and dodecanoic acid
Cas Number:
2166089-27-4
Molecular formula:
Non applicable (UVCB)
IUPAC Name:
Nonanoic acid, mixed diesters, with oxybis[propanol] and dodecanoic acid
Test material form:
liquid
Details on test material:
- Appearance: Limpid liquid
- Storage condition of test material: Keep container tightly closed. Preferably store in the original packaging. Store at room temperature, protect from humidity.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
Albino
Sex:
male/female
Details on test animals or test system and environmental conditions:
Species Rats/Sprague-Dawley derived, albino
Source: Received from SAGE® Labs on January 16, 2019
Number of animals 5 males and 5 females (females were nulliparous and non-pregnant).
Age and body weight Young adult animals (8-9 weeks old) were selected. Males 249-291 g and females 176-200 g. Body weight variation did not exceed +/- 20% of the sex mean.
Identification by a stainless steel ear tag
Health inspection After clipping and prior to application, the animals were examined for health, weighed (initial) and the skin checked for any abnormalities. Ten healthy, naive rats (five males and five females; not previously tested) were selected for test.

6.3. Animal husbandry
Conditions
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 12 air changes per hour, a temperature of 19-23ºC, a relative humidity of 30-69% and 12 hours artificial fluorescent light and 12 hours darkness per day.

Accommodation
Animals were housed in caging which conforms to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals (Natl. Res. Council, 2011) and group housed, except on the day of application, at which time they were singly housed until the animals were deemed acceptable, based on observations, to return to group housing. Enrichment (e.g., toy) was placed in each cage and litter was changed at least once per week.
Acclimatization period was to 7 days before start of treatment under laboratory conditions.

Diet
Envigo Tekiad Global 16% Protein Rodent Diet® #2016. The diet was available ad libitum.

Water
Filtered tap water was supplied ad libitum.

Contaminants
There were no known contaminants reasonably expected to be found in the food or water at levels which would have interfered with the results of this study. Analyses of the food and water are conducted regularly and the records are kept on file at Product Safety Labs.

Administration / exposure

Type of coverage:
other: 2-inch x 3-inch, 4-piy gauze pad wrapped with 3-inch Durapore
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Method Dermal application.

Clipping On the day prior to application

Application 5000 mg/kg bw of the test substance was applied evenly over a dose area of approximately 2 inches x 3 inches and covered with a 2-inch x 3-inch, 4-piy gauze pad. The gauze pad and entire trunk of each animal were then wrapped with 3-inch Durapore tape to avoid dislocation of the pad and to minimize loss of the test substance. The rats were then returned to their designated cages. The day of application was considered Day 0 of the study.
After 24 hours of exposure to the test substance, the pads were removed and the test sites were gently cleansed with a 3% soap solution followed by tap water and a clean paper towel to remove
any residual test substance.
Duration of exposure:
24 hours
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 males / 5 females
Control animals:
not required
Details on study design:
The test item was administered to five Sprague-Dawley rats of each sex by a single dermal application at 5000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and determination of body weight were recorded prior to test substance application (initial) and again on Days 7 and 14 (terminal). Macroscopic examination was performed after terminal sacrifice (Day 15).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality occurred.



Clinical signs:
There were no signs of gross toxicity, dermal irritation, adverse clinical effects, or abnormal behavior. All animals appeared active and healthy during the study.
Body weight:
All animals gained body weight during the study.





Gross pathology:
No gross abnormalities were noted for any of the animals when necropsied at the conclusion ofthe 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 value of the test material in Sprague Dawley rats was established to exceed 5000 mg/kg body weight.
Executive summary:

In an acute dermal toxicity study performed according to the OECD Guideline 402 and in compliance with GLP, a single dose of 5000 mg/kg bw of the test substance was applied onto the intact skin of 5 male and 5 female Sprague Dawley rats under occlusive conditions for 24 hours. Animals were then observed for mortality, dermal reactions, body weight changes and clinical signs of toxicity for 14 days.

No mortality occurred during the study. No systemic clinical signs related to the administration of the test substance were observed. No signs of gross toxicity, dermal irritation, adverse clinical effects, or abnormal behavior. All animals appeared active and healthy during the study. Body weight gain of the animals remained normal throughout the study. The macroscopic examination of the animals at the end of the study did not reveal any treatment-related changes.

Rat Dermal LD50 >5000 mg/kg bw.

Under the test conditions, the dermal LD50 of the test substance is >5000 mg/kg bw in rats therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the GHS. No signal word or hazard statement is required.

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