bis(hydrogenated tallow C16-18-alkyl)hydroxylamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-06-06 to 1995-08-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

31 July 1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24 February 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

-

EC Number:

418-370-0

EC Name:

-

Cas Number:

143925-92-2

Molecular formula:

C32-36 H67-74 N1 O1

IUPAC Name:

N-hexadecyl-N-octadecylhydroxylamine

Test material form:

solid

Details on test material:

- State of aggregation: solid

Test animals

Species:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited; Animal Production; 4332 Stein / Switzerland
- Age at study initiation: young adult albino rats
- Weight at study initiation: 201 to 230 g
- Fasting period before study: none
- Housing: individually housed in Macrolon cages type 3, with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin, France)
- Diet: Rat diet (NAFAG 890, NAFAG, Gossau/SG, Switzerland) ad libitum
- Water: tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2°C
- Humidity: relative humidity of 55 ± 10%
- Air changes: approximately 15 air changes per hour
- Photoperiod: 12 hour/day light cycle

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

arachis oil

Details on dermal exposure:

TEST SITE
- Area of exposure: 10 % of body surface
- Type of wrap: gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing: with luke warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg
- Concentration: 500 mg/mL
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied: 4 mL/kg bw
- Concentration: 500 mg/mL

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days; Signs and symptoms: daily for 14 days; Body weight: immediately before application and on days 7 and 14
- Necropsy of survivors performed: yes

Statistics:

NA

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred in this study.

Clinical signs:

other: No signs of acute dermal toxicity were observed in this study.

Gross pathology:

At necropsy, no deviations from normal morphology were found.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

At 2000 mg/kg the test item elicited no signs of acute toxicity in male and female rats.

Executive summary:

In a GLP-compliant acute dermal toxicity study (OECD 402), the test article in oleum arachidis was administered to five male and five female rats by dermal application at 2000 mg/kg body weight for 24 hours. The test article was evenly dispersed on the skin covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the skin reaction was appraised repeatedly. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred. No signs of acute dermal toxicity were observed in this study and animals showed normal body weight gain. At necropsy, no deviations from normal morphology were found. In conclusion, the dermal LD50 value in Wistar rats was established to exceed 2000 mg/kg body weight.