2,4,6-trichloroaniline

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014-01-15 until 2014-01-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

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:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,4,6-trichloroaniline

EC Number:

211-219-8

EC Name:

2,4,6-trichloroaniline

Cas Number:

634-93-5

Molecular formula:

C6H4Cl3N

IUPAC Name:

2,4,6-trichloroaniline

Test material form:

solid: crystalline

Details on test material:

Physical state: Off white crystals
- Expiration date of the lot/batch: Recertification date end November 2015
- Storage condition of test material: Room temperature (<30°C)

Test animals

Species:

rat

Strain:

other: RccHan:(WIST)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 205-245 g
- Fasting period before study: None
- Housing: Individually in Type II. polypropylene/polycarbonate cages.
- Diet: ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance" ad libitum
- Water: Tap water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 24 - 51
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 15 January 2014 To: 29 january 2014

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Back (shaved 24 hours prior to application).
- % coverage: Approximately 10% total body surface.
- Type of wrap if used: Gauze pads kept in contact with the skin with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semi occlusive plastic wrap.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test item was removed, using body temperature water.
- Time after start of exposure: 24 hours.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw .
- Constant volume or concentration used: yes
- For solids, paste formed: Yes (moistened with water and distributed as uniformly as possible onto the skin).

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:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 5 hours after application and once daily thereafter (observations); Day 0 (before the experiment) and on Days 7 and 14 (body weights).
- Necropsy of survivors performed: Yes.

Statistics:

Not applicable (limit test, no mortalities).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities.

Clinical signs:

other: No treatment-related clinical signs or signs of skin irritation.

Gross pathology:

No treatment related effects.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median lethal dose after a single dermal administration (acute dermal LD50) was greater than 2000 mg/kg bw in male and female RccHan:WIST rats.

Executive summary:

Five male and five female RccHan:(WIST) rats were treated with a single, semi occlusive dermal application of the test substance at a dose of 2000 mg/kg bw. The test item was applied as supplied. The application period was 24 hours, followed by a 14-day observation period. Clinical observations along with a check of viability and mortality were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. Rats were killed and given a gross macroscopic examination at the end of the 2-week observation period (Day 14).

There were no mortalities. No adverse clinical signs were observed after treatment with the test item. There were no treatment related effects on body weight or body weight gain during the observation period. There were no treatment-related effects at necropsy.

The median lethal dose after a single dermal administration (acute dermal LD50) was greater than 2000 mg/kg bw in male and female RccHan:WIST rats.