N-methoxy-1-(2,4,6-trichlorophenyl)propan-2-amine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Remarks:

The study on acute dermal toxicity was conducted solely to comply with a non-EU national registration requirement, and has been provided here in accordance with REACH, Article 22(1)e.

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 November 2013 to 29 November 2013

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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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

methoxy[1-(2,4,6-trichlorophenyl)propan-2-yl]amine

EC Number:

941-634-6

Cas Number:

1228284-78-3

Molecular formula:

C10H12Cl3NO

IUPAC Name:

methoxy[1-(2,4,6-trichlorophenyl)propan-2-yl]amine

Test material form:

other: liquid

Details on test material:

- Physical state: Brown liquid
- Expiration date of the lot/batch: Recertification date end September 2015
- Storage condition of test material: Room temperature (<30°C), protected from light and humidity

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: 220-257 g
- Fasting period before study: No
- 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 (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 7-9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.7-24.3
- Humidity (%): 31-54
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 13 November 2013 To: 29 November 2013

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): 1.54 mL/kg bw (x1300 mg/mL = 2000 mg/kg bw).

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.

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

Clinical signs:

other: Decreased activity (3/10), hunched back (8/10), incoordination (9/10), irritability (3/10) and continuous tremors (9/10). All animals were symptom free from 7 days after the treatment. No signs of dermal irritation.

Gross pathology:

No treatment-related findings.

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 of the test substance after a single dermal administration (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, 24 hour, semi occlusive dermal application of the test substance at a dose of 2000 mg/kg bw. Clinical observations along with a check of viability and mortality were assessed in 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. All animals were killed and subjected to a gross macroscopic examination at the end of the 14-day observation period (Day 14).

There was no mortality. Decreased activity (3/10), hunched back (8/10), incoordination (9/10), irritability (3/10) and continuous tremors (9/10) were seen but all animals were symptom free from 7 days after the treatment. No treatment related skin irritation was observed in any animal throughout the study. Slight body weight loss was noted in one male rat and four female rats between Days 0 and 7. Bodyweights of these animals had recovered by the end of the observation period. There was no evidence of the any observations at a dose level of 2000 mg/kg bw at necropsy.

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