Tetraethylammonium hydroxide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 September, 2010 - 14 October, 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

(1987)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetraethylammonium hydroxide

EC Number:

201-073-3

EC Name:

Tetraethylammonium hydroxide

Cas Number:

77-98-5

Molecular formula:

C8H20N.HO

IUPAC Name:

tetraethylammonium hydroxide

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Tetraethylammonium Hydroxide, (35% TEAH, in water)
- Description: clear liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Boyertown, PA
- Age at study initiation: no data
- Weight at study initiation: males: 268 - 286 g; females: 188 - 240 g
- Housing: Individually housed in suspended wire cages
- Diet: Free access to PMI Rat Chow diet
- Water: Free access to water.
- Acclimation period: At least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
The day prior to application of the test article, the dorsal area of the trunk of each animal was clipped free of hair. The prepared site was approximately 10% of the body surface and remained intact.

A single dose of the test substance was applied to the prepared site, over a porous gauze dressing measuring 4 x 6 cm. The torso was wrapped with ppastic in a semi-occlusive manner and was secured with non-irritating tape.

REMOVAL OF TEST SUBSTANCE
Residual test sbstance was removed by gently washing with distilled water.

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:

Dose volume: no data

Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: twice a day
Body weights: pretest, weekly and at termination
Clinical signs: 1, 2 and 4 hours and once daily for 14 days
- Necropsy of survivors performed: All animals were examined for gross pathology.

Statistics:

None.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

dissolved

Remarks:

35% aqueous solution

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 700 mg/kg bw

Based on:

other: pure test substance

Mortality:

2 males and 1 female died.

Clinical signs:

other: The male and female rats were normal up to 4 hours after dosing. Shortly after the 4 hour observation, among 2 males convulsing and vocalizing were observed. The 2 males were found dead on day 1. All remaining males were normal at all other observation pe

Gross pathology:

Necropsy observations were normal except for the skin, which appeared to have pale and dark areas (necrotic). The dose sites appeared to have been depilated for 3 out of 10 animals. Two males were noted with redness and/or brown staining of the nose/mouth area. One female was noted with red staining of the nose/mouth area.

Other findings:

Skin observations of the surviving animals at 24 hours were necrotic with pale areas. Edema was absent to very slight. On days 7 and 14, skin was necrotic with flaking of the skin on 2 animals by day 14. There was no edema noted.

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

In an acute dermal toxicity study with rats, performed according to OECD 402 guideline and GLP principles, an LD50 >2000 mg/kg bw was determined for TEAH (35% aqueous solution). This is equivalent to an LD50 of >700 mg/kg bw for the pure substance.

Executive summary:

An acute dermal toxicity test with 35% tetraethylammonium hydroxide was performed according to OECD 402 test guideline and GLP principles. Male and female rats were exposed to 2000 mg/kg bw. Two males and one female died.

Clinicals signs included convulsing, vocalizing, few feces, wetness of the anogenital area and chromorhinorrhea. Skin observations of the surviving animals at 24 hours revealed necrotic tissue with pale areas. Edema was absent to very slight. The LD50 was found to be >2000 mg/kg bw, this is equivalent to an LD50 of >700 mg/kg bw for the pure substance.

Therefore, TEAH (pure substance) is classified as category 3 for dermal toxicity according to Regulation No. 1272/2008 and should be labelled with H311: Toxic in contact with skin.