4-morpholinecarbaldehyde

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, acceptable for assessment

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Range-Finding Toxicity Data: List VIII

Author:

Carpenter CP, Weil CS, Smyth Jr. HF

Year:

1974

Bibliographic source:

Toxicology and Applied Pharmacology 28: 313-319

Reference 2

Reference Type:

publication

Title:

Range-Finding Toxicity Data: List VI

Author:

Smyth Jr. HF et al.

Year:

1962

Bibliographic source:

Am. Ind. Hyg. Assoc. J., 23: 95-107

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not applicable

Principles of method if other than guideline:

Acute dermal toxicity was estimated by a technique closely akin to the one-day cuff Method of Draize and associates.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-morpholinecarbaldehyde

EC Number:

224-518-3

EC Name:

4-morpholinecarbaldehyde

Cas Number:

4394-85-8

Molecular formula:

C5H9NO2

IUPAC Name:

morpholine-4-carbaldehyde

Details on test material:

- Name of test material (as cited in publication): 4-Formylmorpholine
- no further data

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5 - 3.5 kg
- no further data

ENVIRONMENTAL CONDITIONS
- no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

Acute dermal toxicity was estimated by a technique closely akin to the one-day cuff method of Draize and associates using groups of four male albino New Zealand rabbits weighing 2.5 to 3.5 kg.

The fur was removed from the entire trunk by clipping, and the dose was retained beneath an impervious plastic film. The animals were immobilized during the 24-hour contact period, after which the film was removed and the rabbits were caged for the subsequent 14-day observation period.
Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range were estimated by the method of Thompson using the tables of Weil.

Duration of exposure:

24 hours

Doses:

18400 mg/kg bw (corresponding to 16 mL/kg bw under consideration of the absolute density)

No. of animals per sex per dose:

4 male animals per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- no further data

Statistics:

The most probable LD50 value and its fiducial range are estimated by the method of Thompson using the tables of Weil.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 18 400 mg/kg bw

Remarks on result:

other: LD50 > 16 mL/kg bw

Mortality:

no deaths

Clinical signs:

other: no data

Gross pathology:

no data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

Based on the results observed and by applying the evaluation criteria it was concluded that N-formylmorpholine don´t need to be classified as toxic after single dermal application according to Regulation 1272/2008/EC. (Carpenter, 1974)