Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides

Acute Toxicity: dermal

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: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides

EC Number:

295-714-4

EC Name:

Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides

Cas Number:

92128-22-8

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Reaction products of tall-oil fatty acids and (3-aminopropyl)dimethylamine

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan GmbH (Horst, Netherlands)
- Age at study initiation: 9-13 weeks
- Weight at study initiation: 236-263 g for males and 213-215 g for females
- Fasting period before study: none
- Housing: individually in polycarbonate cages on low dust wood granulate bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 5
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 30 cm2
- % coverage: approx. 10
- Type of wrap if used: gauze patch fixed with an elastic adhesive tape pervious to air

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with tepid water using soap
- Time after start of exposure: approx. 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 15.7-17.5 mg/cm2 (males) and 14.2-14.3 mg/cm2 (females)

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several times on the day of application as well as at least once daily during observation period (clinical signs, mortality); surviving animals were weighed individually at application, after one week and at the end of the 14-day observation period.
- Necropsy of survivors performed: yes

Statistics:

none (limit test)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

All male and female animals survived the treatment.

Clinical signs:

other: At 2000 mg/kg the following local signs were observed: males: thickening and partial: reddening, indurations and blue indurations, encrustation and formation of scale of the treatment area (occurrence of signs from day 2 until day 13); females: thickening

Gross pathology:

The necropsies performed at the end of the study revealed no particular findings in male animals. In females the following signs were not completely healed at final necropsy: encrustation in all animals and indurations in two animals.

Other findings:

none

Applicant's summary and conclusion

Executive summary:

The acute dermal toxicity of the test substance was low with an LD50 value > 2000 mg/kg bw for male and female rats according to OECD TG 402. Single semiocclusive administration of 2000 mg/kg bw for 24 hours was tolerated without mortalities. Local signs were observed in male ( thickening and partial: reddening, indurations and blue indurations, encrustation and formation of scale of the treatment area) and female ( thickening and partial: reddening, encrustation and indurations of the treatment area) animals. Body weight development was not affected in males, whereas two females revealed a decreased body weight gain during the 14-day post observation period.