cis-4-[3-(p-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09. - 12.2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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:

February 24, 1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

certified by Umweltministerium Baden-Württemberg

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

cis-4-[3-(p-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine

EC Number:

266-719-9

EC Name:

cis-4-[3-(p-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine

Cas Number:

67564-91-4

Molecular formula:

C20H33NO

IUPAC Name:

(2R,6S)-4-[3-(4-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI (Han) SPF

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 12 weeks
- Weight at study initiation: 248.2 g (mean bw of males); 198.6 (mean bw of females)
- Housing: Single housing
- Diet: VRF 1(P), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days
- Method of randomisation in assigning animals to test and control groups: not applicable

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. - 6.00 p.m. / 6.00 p.m. - 6.00 a.m.)

IN-LIFE DATES:
- From: 2010-09-14
- To: 2010-09-28

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal and dorsolateral parts of the trunk
- % coverage: 40 cm² (corresponding to at least 10 %)
- Type of wrap if used: semiocclusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: rinsing with warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 1 application of 5.29 mL/kg bw (5000 mg/kg bw)
- Constant volume or concentration used: yes

Duration of exposure:

24 h

Doses:

- other: 5000 mg/kg bw

No. of animals per sex per dose:

5m / 5f

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of clinical observations: several times on the day of administration, at least once therafter each workday.
- Frequency of weighing: shortly befor administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes
- Clinical signs including body weight : yes
- Other examinations performed: Mortality at least once each workday; Scoring of skin findings 30-60 minutes after removal of the dressing (day 1) and at least weekly and on the last day of observation

Statistics:

No statistical analysis was conducted.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured.

Clinical signs:

other: Male animals systemic effects: - impaired general state and piloerection from study day 6 until day 10 at the latest (all males) - one animal additionally showed dyspnoea from day 8 until day 8 Male animals local effects: - slight to severe erythema (gra

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals examined on the last day of observation.