Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia

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: Full reliable study conducted according to actual guidelines under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia

Molecular formula:

Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia

IUPAC Name:

Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia

Test material form:

other: liquid, solution ~50% a.i.

Details on test material:

- Name of test material (as cited in study report):Octadecanoic acid, 9,10-dihydroxy-, monoammoniumsalt (due to composition renamed to Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia)
- Substance type: fatty acid, hydroxylated
- Physical state: liquid, solution
- Analytical purity: 7 components: Sum: 34.98 area-%, Corrected for water content Water: 49.2 g/100 g (for details see analytical
report No.: 12L00047)
- Lot/batch No.:0008050156
- Expiration date of the lot/batch:18 Jan 2013
- Stability under test conditions: stable
- Storage condition of test material:Room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: approx. 12 weeks
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight)
- Housing:Makrolon cage, type III, Single housing
- Diet (e.g. ad libitum):VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany) ad libitum
- Water (e.g. ad libitum):Tap water ad libitum
- Acclimation period:at least 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22°C ± 3°C
- Humidity (%):30 – 70%
- Air changes (per hr):approx. 10
- Photoperiod (hrs dark / hrs light):12 h / 12 h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Remarks:

solution already containing ~50% water

Details on dermal exposure:

TEST SITE
- Area of exposure: About 40 cm² (corresponds to at least 10% of the body surface)
- Type of wrap if used: covered with an air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, warm water
- Time after start of exposure: 24h after application

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3.96ml/kg bw
- Concentration (if solution): undiluted (already 50% solution in water)
- Constant volume or concentration used: yes
- To ensure the homogeneity the test item was heated at 50°C. The test item was administered hand warm.

Duration of exposure:

24h

Doses:

4000mg/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: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of
observation. Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
- Necropsy of survivors performed: yes
- Scoring of skin findings: Individual readings 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), weekly thereafter and
on the last day of observation.

Statistics:

no special statistical models used

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

No mortality occurred.

Clinical signs:

other: No systemic clinical signs were observed during clinical examination. No local effects were observed.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Under the conditions of this study the median lethal dose (LD50) of the test item Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia (50% active substance in water) after dermal application was found to be greater than 4000 mg/kg bw in male and female rats.