isostearic acid monoisopropanolamide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From March 30, 1999 to April 13, 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

431-540-9

EC Name:

-

Cas Number:

170573-32-7

Molecular formula:

C21H43NO2

IUPAC Name:

N-(2-hydroxypropyl)-2,2,5,8,11,11-hexamethyldodecanamide

Test material form:

other: liquid to paste

Test animals

Species:

rat

Strain:

other: HanIbm: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source: RCC Ltd Biotechnology & Animal Breeding Division CH-4414 Füllinsdorf / Switzerland
Age when treated: 9 weeks for the males and 12 weeks for the females
Temperature: 22 +/- 3°C and relative humidity: 40-70%
Light period: 12 hour light/dark cycle
Diet: pelleted Standard Kliba 3433, ad libitum and water: community tap water, ad libitum

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

polyethylene glycol

Details on dermal exposure:

The test substance was placed into a glass beaker on a tared Mettler balance and the vehicle (polyethylene glycol PEG 300) was added. A weight by volume dilution was prepared using a magnetic stirrer as homogenizer. Homogeneity of the test substance in the vehicle was maintained during treatment. The preparation was made shortly before dosing.
Approximately 24 hours before treatment, the backs of the animals were clipped with an electric clipper, exposing an area of approximately 10% of the total body surface. Only those animals without injury or irritation on the skin were used in the test. On test day 1, the test substance was applied at a dose of 2000 mg/kg bw evenly on the intact skin with a syringe and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage. Application volume/kg bw: 4.0 mL. Twenty-four hours after the application the dressing was removed and the skin was flushed with lukewarm tap water and dried with disposable paper towels. Thereafter, the reaction sites were assessed.

Duration of exposure:

24h

Doses:

2000 mg/kg bw (at a concentration of 0.5 g/mL in vehivle and administered at a volume of 4 mL/kg)

No. of animals per sex per dose:

5

Control animals:

no

Statistics:

No statistical analysis was used as no deaths occurred.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No clinical signs were observed during the observation period.

Gross pathology:

No macroscopic findings were observed at necropsy.

Any other information on results incl. tables

None.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the dermal LD50 was determined to be >2000 mg/kg bw.

Executive summary:

A study was conducted to determine the acute dermal toxicity of the test substance, isoC18 MIPA (100% active), according to OECD Guideline 402 and EU Method B.3, in compliance with GLP. Groups of 5 male and 5 female HanIbm: WIST (SPF) rats were exposed to the test substance (in polyethylene glycol) at a concentration of 2000 mg/kg bw via a semi-occlusive dermal application (4 mL/kg bw) for 24 h. This application was followed by a 14 d observation period. The animals were examined for clinical signs four times during Day 1 and once daily during Days 2-15. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on Day 1 prior to administration and on Days 8 and 15. All animals were necropsied and examined macroscopically. No deaths occurred during the study. No clinical signs were observed throughout the observation period. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were noted at necropsy. Under the study conditions, the dermal LD50 was determined to be >2000 mg/kg bw (Ullmann, 1999).