4-[3-(1-naphthylamino)propyl]morpholine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

September 17, 1981 to October 1, 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study methodology follwed was equivalent or similar to OECD TG 402 and in accordance with the Principles of Good Laboratory Practice (GLP)

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Principles of method if other than guideline:

not applicable

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-[3-(1-naphthylamino)propyl]morpholine

EC Number:

226-033-2

EC Name:

4-[3-(1-naphthylamino)propyl]morpholine

Cas Number:

5235-82-5

Molecular formula:

C17H22N2O

IUPAC Name:

N-[3-(morpholin-4-yl)propyl]naphthalen-1-amine

Constituent 2

Reference substance name:

Oleic acid

EC Number:

204-007-1

EC Name:

Oleic acid

Cas Number:

112-80-1

Molecular formula:

C18H34O2

IUPAC Name:

octadec-9-enoic acid

Constituent 3

Reference substance name:

Solvent naphtha (petroleum), heavy arom.

EC Number:

265-198-5

EC Name:

Solvent naphtha (petroleum), heavy arom.

Cas Number:

64742-94-5

Molecular formula:

not applicable

Test material form:

liquid

Details on test material:

Commercial Product

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: H.A.R.E. - Rabbits for Research, Hewitt, N.J.
- Age at study initiation: young adults
- Weight at study initiation: 2.0 - 4.0 kg
- Housing: individually housed
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): as per standard recommendations
- Humidity (%): as per standard recommendation
- Air changes (per hr): as per standard recommendation
- Photoperiod (hrs dark / hrs light): as per standard recommendation

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Shortly before dosing, the fur was clipped from the dorsal trunk area of each rabbit with electric clippers. During this procedure, care was taken to avoid accidental abrasion to the skin. The clipped area constituted constituted approximately 10% of the total body surface of each animal. Immediately after application, the trunk of each animal was wrapped with an occlusive binder. This consisted of a layer of plastic wrap, a protective cloth and a stockinette sleev all secured in place with masking tape.

Duration of exposure:

24 hours

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

3 male + 3 female rabbits

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for mortality and toxic signs frequently on the day of dosing and twice daily thereafter for 14 days (at least 5 hours apart). The animals were weighed and weights recorded prior to initiation of the study and on days 8 and 15 of the study.
- Necropsy of survivors performed: yes

Statistics:

not applicable

Results and discussion

Preliminary study:

not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality noted

Clinical signs:

other: No clinical signs noted

Gross pathology:

No noteworthy findings were noted

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

As no mortality was noted in the acute dermal application study of Marker MP tested at the limit dose of 2000 mg/kg body weight in New Zealand White rabbits, Marker MP will not be classified for dermal toxicity.

Executive summary:

The acute dermal toxicity potential of Marker MP was evaluated in New Zealand White rabbits and under the conditions of the study, no mortality was noted in any of the rabbits dermally exposed to the limit dose of 2000 mg/kg body weight. As per Guidance to Regulation (EC) No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Marker MP will not be classified.