Ethyldiisopropylamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 March 2012 - 06 April 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

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

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethyldiisopropylamine

EC Number:

230-392-0

EC Name:

Ethyldiisopropylamine

Cas Number:

7087-68-5

Molecular formula:

C8H19N

IUPAC Name:

ethylbis(propan-2-yl)amine

Details on test material:

- Name of test material: ETHYLDIISOPROPYLAMINE (EDIPA)
- Physical state: colorless to light yellow liquid
- Lot/batch No.: A20NCU010101
- Analytical purity: 99.74%
- Expiry date: April 2013
- Storage conditions: at room temperature and protected from humidity.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 8 weeks old on the day of treatment
- Mean body weight at study initiation: . the males had a mean body weight of 357 g (range: 349 g to 372 g) and the females had a mean body weight of 228 g (range: 224 g to 236 g)
- Fasting period before study: yes, during the night before treatment
- Housing: polycarbonate cages with stainless steel lids
- Diet: SSNIFF R/M-H pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: the animals were acclimated to the study conditions for a period of 5 days (females) or 8 days (males) before treatment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h (7:00 - 19:00)

IN-LIFE DATES: 20 March 2012 to 06 April 2012.

Administration / exposure

Type of coverage:

other: hydrophilic gauze pad

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 10% of body surface, dorsal site
- Type of wrap if used: hydrophilic gauze pad + adhesive hypoallergenic aerated semi-occlusive dressing + restraining bandage

REMOVAL OF TEST SUBSTANCE
- Removal of dressing: 24h post-exposure
- Washing: at 24h post-exposure, with a moistened cotton pad

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Constant volume: no
- For solids, paste formed: not applicable

Doses:

2000 mg/kg/day.

No. of animals per sex per dose:

5 animals per dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Clinical observations: frequently during the hours following treatment; then, at least once a day.
- Body weight: just before treatment on day 1; then on days 8 and 15.
- Necropsy of survivors performed: yes (macroscopic).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No unscheduled deaths occurred during the study.

Clinical signs:

other: No clinical signs indicative of systemic toxicity were observed in any animal.

Gross pathology:

At necropsy, 14 days after dermal application of the test item to rats at 2000 mg/kg/day, no changes that could be related to treatment were observed.

Other findings:

Very slight to well-defined erythema was observed on the application site of all females and 4/5 males between days 2 and 5.
Scabs were recorded on the application site of 2/5 females and 4/5 males between days 3 and 13.

Any other information on results incl. tables

see Executive summary

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

The dermal LD0 of the test item, ETHYLDIISOPROPYLAMINE (EDIPA), was higher than 2000 mg/kg in rats.

Executive summary:

The potential toxicity of the test item, ETHYLDIISOPROPYLAMINE (EDIPA) was evaluated following a single dermal application to rats. The study was based on the OECD No. 402 (24th February 1987) and Commission Regulation (EC) (No. 440/2008, B.3, 30 May 2008) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice.

ETHYLDIISOPROPYLAMINE (EDIPA), was applied in its original form to the skin of five female then five male Sprague-Dawley rats at the dose-level of 2000 mg/kg. The application site was covered with a hydrophilic gauze pad for 24 hours. Each animal was observed at least once a day for mortality and clinical signs for 15 days. From day 2, any local reactions at the treatment site were also noted. Body weight was recorded on day 1 and then on days 8 and 15. On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination. No tissues were preserved. Macroscopic lesions were preserved and no microscopic examination was performed.

No unscheduled deaths occurred during the study. No clinical signs indicative of systemic toxicity were observed in any animal. Lower body weight gain was recorded in 2/5 females and all males during the first week of observation period, and in 1/5 male during the last week of observation period. Very slight to well-defined erythema was observed on the application site of all females and 4/5 males between days 2 and 5.

Scabs were recorded on the application site of 2/5 females and 4/5 males between days 3 and 13. At necropsy, 14 days after dermal application of the test item to rats at 2000 mg/kg/day, no changes that could be related to treatment were observed.

The dermal LD₀ of the test item, ETHYLDIISOPROPYLAMINE (EDIPA), was higher than 2000 mg/kg in rats.