Registration Dossier

Diss Factsheets

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:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Hydrocarbons, C12-C16, n-alkanes, isolkanes, alkenes
EC Number:
810-258-3
Molecular formula:
not applicable; UVCB
IUPAC Name:
Hydrocarbons, C12-C16, n-alkanes, isolkanes, alkenes
Constituent 2
Reference substance name:
Alcohols, C2-33, manuf. of, by-products from overheads
IUPAC Name:
Alcohols, C2-33, manuf. of, by-products from overheads
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): HF-1000 solvent
- Substance type: Product
- Physical state: Clear, colourless, oily liquid
- Analytical purity: 100%
- Lot/batch No.: 1881046
- Expiration date of the lot/batch: 03/29/18
- Storage condition of test material: ambient

Test animals

Species:
rat
Strain:
other: CD [Crl:CD (SD)BR] (Sprague-Dawley)
Sex:
male/female
Details on test animals or test system and environmental conditions:
Source: Charles River Canada, Montreal, Quebec
Number/Sex: 3 females for the preliminary test
5 males and 5 females for the limit test
Body Weight Range: males - 282 - 300 g
(Limit Test) females - 211 - 221 g
Acclimatization Period: 8 days
(Limit Test)
Age at Study Start: males - 8 - 9 weeks
(Limit Test) females - 10 - 11 weeks
Animal Identification: Tail markings

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The calculated dose volume of the test item was placed onto the shaved
testing skin area, then a 2-ply sheet of gauze, was applied over the treated
area. The whole trunk of the animal was wrapped by means of a semiocclusive
dressing (i.e. CobanTM 3M self-adherent wrap) and secured at
the ends with tape (zonas porous tape).

Duration of exposure:
Following dosing, the rats were then placed back into their cages for a 24-
hour exposure period. At the end of the 24-hour exposure period, the
wrappings were removed and the exposed skin was cleansed by rinsing
with sterile Water for Injection USP.
Doses:
The limit test was performed on 5 males and 5 females using one dose
level of 2.0 g/kg. The doses of the test item were individually calculated
for each rat based on the body weight of the animal taken prior to dosing,
at a dose volume of 2.51 mL/kg.
No. of animals per sex per dose:
A limit test was performed on 5 male and 5 female Sprague-Dawley rats. Animals
received the test item at a dose volume of 2.51 mL/kg by dermal application at a dose
level of 2000 mg/kg.
Control animals:
not required

Results and discussion

Preliminary study:
The clinical signs observed consisted of very slight erythema, for the first 4 days post unwrapping. All animals gained body weight. No gross findings were observed during necropsy on any of the 3 animals
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
other: The abnormal clinical signs observed during the 14-day observation period were limited to erythema of the skin at the site of application. All males exhibited very slight erythema (score 1) from Day 2 to Day 3. Very slight erythema (score 1) was still obs
Gross pathology:
All animals were sacrificed at the end of the study and full gross necropsies were performed. No gross pathological findings were observed
at necropsy.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Under the conditions used in this study, HF-1000 Solvent was not lethal by the dermal route of administration in male and female rats at a dose level of 2000 mg/kg. The test compound did not exhibit any systemic toxic effect, and no specific organs for toxicity were identified. The test item was slightly irritating to the exposed skin, however the irritation was reversible. Based on the above findings, Acute Dermal LD50 in Rats of the test item, HF-1000 Solvent, was estimated to be greater than 2000 mg/kg body weight.
Executive summary:

This acute dermal toxicity study of the test item, HF-1000 Solvent, was carried out by Nucro-Technics according to Study Plan No. INT/296963.

A limit test was performed on 5 male and 5 female Sprague-Dawley rats. Animals received the test item at a dose volume of 2.51 mL/kg by dermal application at a dose level of 2000 mg/kg. The dose volumes of the test item were individually calculated for each animal based on the body weight of the animal. The calculated dose portion of the test item was placed on the shaved skin of the rat. A 2-ply gauze sheet was applied over the treated area, then the trunk of the rat was wrapped by a semi-occlusive, self-adherent wrap and secured at the ends with adhesive tape. Animals were exposed to the test item for a 24-hour period. At the end of this period, the wrappings were removed and the skin was cleansed by rinsing with sterile Water for Injection USP.

Animals were observed closely for the first 72 hours following dosing, then twice daily for a 14-day observation period for mortality and adverse clinical signs. Skin irritation (erythema and oedema) was recorded daily using the Draize scoring system. At the end of the study, all animals were sacrificed and submitted for gross necropsy.

The abnormal clinical signs were limited to minimal skin irritation. All 10 animals exhibited very slight erythema after wrap removal, from Day 2 to Day 4 for males and from Day 2 to Day 3 for females. By Day 5 for males and Day 4 for females, all signs of erythema had cleared.

Body weights of the animals were determined prior to test item administration, on Day 8 and again on Day 15. All animals gained body weight by Day 8 and also by the end of the study period.

At necropsy, no gross pathological lesions were observed.

Under the conditions used in this study, HF-1000 Solvent was not lethal by the dermal route of administration in male and female rats at a dose level of 2000 mg/kg. The test item did not cause any systemic toxic effect, and no specific organs for toxicity were identified. The test item was slightly irritating to the exposed skin, however the irritation was reversible. Based on the above findings, the Acute Dermal LD50 in rats of the test item, HF-1000 Solvent, was estimated to be greater than 2000 mg/kg body weight.