Trimorpholinophosphine oxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 Jan - 07 Mar 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Trimorpholinophosphine oxide

EC Number:

224-662-7

EC Name:

Trimorpholinophosphine oxide

Cas Number:

4441-12-7

Molecular formula:

C12H24N3O4P

IUPAC Name:

trimorpholinophosphine oxide

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sue Charlaronne, France
- Age at study initiation: 11-12 weeks
- Housing: the rabbits were housed individually in stainless steel rabbit cages, equipped with feed hoppers, drinking water bottles, with wood and haysticks for gnawing.
- Diet: Pelleted Provimi Kliba 3418 rabbit maintenance diet, ad libitum (Provimi Kliba AG, Kaiseraugst, Switzerland)
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: not required, untreated sites of the same animal served as the control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
the test material was moistened with approx. 0.1 mL of purified water before application

Duration of treatment / exposure:

4 h

Observation period:

72 h
Reading time points: 1, 24, 48 and 72 h

Number of animals:

3 (1 male, 2 females)

Details on study design:

TEST SITE
- Area of exposure: approximately 10x10 cm
- Type of wrap if used: the test substance was applied on the intact, shaved skin on a surgical gauze and the area was covered with a semi-occlusive dressing. The patch was held in place with non-irritating semi-occlusive adhesive tape that was wrapped around the abdomed of the animals.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the application sites were washed with water to remove any residual test substance
- Time after start of exposure: 4 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- For solids, paste formed: yes

SCORING SYSTEM: Draize scoring system acc. to EEC commission directive 92/69/EEC

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritant / corrosive response data:

No skin irritation effects were observed; all scores were 0 at all reading time points (after 1 ,24, 48, 72 hours and 7 days) for 3/3 animals.

Other effects:

There was no mortality and no clinical signs of toxicity were observed during the study period. The body weight gains were within the normal ranges during the study period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

CLP: not classified

Executive summary:

The test material is considered to be not irritating to rabbit skin under the experimental conditions followed.