Reaction product of Aminoguanidine bicarbonate and Tall Oil fatty acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02.01.2001 to 17.01.2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well-documented, GLP study, performed in accordance with the OECD Guideline 402 (1987; Acute dermal toxicity).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

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

Test material information

Constituent 1

Reference substance name:

-

EC Number:

442-600-9

EC Name:

-

Molecular formula:

The substance is a UVCB for which it is not possible to provide a molecular formula

IUPAC Name:

(9E)-N-[(N'-hexadecanoyloctadecanehydrazido)methanimidoyl]octadec-9-enamide

Details on test material:

Description: Complex reaction product of an aminate base-carbonate and fatty acids
Chemical name: HiTEC 7134 Performance additive
- Physical state: viscous liquid
- Storage condition of test material: ambient temperature in the dark

Test animals

Species:

rat

Strain:

other: Alpk: APfSD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
This particular strain of rat was used due to the substantial background data available in the Laboratory which performed the study.
- Source: Rodent Breeding Unit, Alderley Park, Macclesfield, Cheshire, UK
- Age at study initiation: 8-12 w
- Weight at study initiation: males 286-391 g, females 211-237 g
- Housing: individually in cages
- Diet: ad libitum, RM1, supplied by Special Diet Services Limited, Witham, Essex, UK
- Water: ad libitum
- Acclimation period: at least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 7X7 cm
- % coverage: 100
- Type of wrap if used: foil backed gauze patch held by a cohesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with clean swabs of absorbent cotton wool soaked in clean warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 ml/kg bw

VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle used

Duration of exposure:

24 h

Doses:

2000 mg/kg bw; selcted based on the results of the preliminary phase study, which is not reported.

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the rats were observed twice following application on day 1 for gross abnormalities, and once every day up to day 15 for systemic toxicity and skin irritation. Weights were recorded immediately before the dose application (day 1) and on days 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology of all thoracic and abdominal viscera

Statistics:

Not used

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died during the experiment.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No signs of toxicity were detected.

Other findings:

Signs of slight skin irritation were seen in all animals, but they were completely reverrsible till the end of the study.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

H7134 did not exert any acute toxicity after its dermal application on the skin of rats. The LD50 is higher than 2000 mg/kg bw.

Executive summary:

In an acute dermal toxicity study, five male and five female Alpk: AP_fSD rats were dermally exposed to 2000 mg/kg bw of H7134 for 24h. The body surface exposed was 7X7 cm and it was initially clipped free of hair. Animals were then observed daily for 14 days, and their body weights were recorded at several intervals. No mortality occurred during the conduction of the experiment. Based on these results the dermal LD₅₀males, females is considered to be > 2000 mg/kg bw. No treatment related clinical signs, necropsy findings or changes in body weights were detected. Slight skin irritation was detected in all animals, which totally resoved by the termination of the study. The study was performed in acordance with the OECD Guideline 402.