Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethanolamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013-02-07 to 2013-02-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted by GLP Guidelines according to OECD 402 protocol with no deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Undiluted Isostearamide DEA was applied to the closely clipped, intact skin of New Zealand white male and female rabbits (5 each) at a dose level 2000 mg/kg. The treated areas were covered with two layers of porous gauze dressing and a plastic sheet, which was secured in place with non-irritating surgical tape. The animals were observed for clinical signs for a period of 14 days (or until death). Necropsy of all animals was performed.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isostearamide DEA

IUPAC Name:

Isostearamide DEA

Test material form:

other: Yellow liquid

Details on test material:

Batch Number OE11208
Purity: 100% - UVCB

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kuiper Rabbitry
- Age at study initiation: at least 12 weeks
- Weight at study initiation: 2.4 - 3.0 kg
- Fasting period before study: None
- Housing: Individually caged in stainless steel cages
- Diet (e.g. ad libitum): Purina Rabbit Chow, ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 63 - 73 oF
- Humidity (%): 30 - 70%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Twenty-four hours prior to application of the test material, the dorsal and ventral areas of the trunks of the animals were shaved with electric clippers. Undiluted Isostearamide DEA to the intact skin of New Zealand white male and female rabbits at a dose of 2000 mg/kg. The treated areas were covered with two layers of porous gauze dressing and a plastic sheet, which was secured in place with non-irritating surgical tape. The animals were then returned to their individual cages.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

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: observations were performed once daily, the weight change was recorded at 7 and 14 days after dosing
- Necropsy of survivors performed: yes
- Other examinations performed: none

Statistics:

Satistical analysis was not performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: Erythema, edema, and desquamation were seen in some animals up to day 12. By day 12, all animals appeared normal and healthy.

Gross pathology:

No findings were seen at necropsy.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The Acute Skin Absorption Minimal Lethal Dose for male and female rabbits was found to be > 2000 mg/kg.

Executive summary:

Undiluted Isostearamide DEA was applied to the intact skin of New Zealand white male and female rabbits at a dose of 2000 mg/kg. The treated areas were covered with two layers of porous gauze dressing and a plastic sheet, which was secured in place with non-irritating surgical tape. Observations were made for toxic signs and the viscera of the test animals were examined macroscopically.

The only clinical signs included erythema, edema, and desquamation up to day 12 after dosing. All animals appeared normal and healthy from days 12 - 14. No mortality was seen, and there were no unusual findings at necropsy. The LD50 of Isostearamide DEA is > 2000 mg/kg.