2,2'-methyliminodiethanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1996

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-methyliminodiethanol

EC Number:

203-312-7

EC Name:

2,2'-methyliminodiethanol

Cas Number:

105-59-9

Molecular formula:

C5H13NO2

IUPAC Name:

2-[(2-hydroxyethyl)(methyl)amino]ethan-1-ol

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.0 - 3.0 kg

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 h

Doses:

no data

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

Material was applied to the clipped dorsal trunk skin and maintained in occlusive contact for 24 h by gauze which was placed over the dose, covered with impervious polyethylene sheeting, and retained with VETRAP bandaging tape. Animals were examined for signs of toxic and/or pharmacologic effects daily and for local skin effects at 17 and 14 d after removal of the occlusive dressing. Animals were weighted before dosing and at days 7 and 14 post dosing. All animals were subjected to gross necropsy examination.

Clinical signs daily during the observation period (14 d).
- Local skin effects observations: 1 hr, 7 d, 14 d after removal of occlusive dressing.
- Gross pathological examinations on all animals.
- Body weights were recorded before dosing, and 7 and 14 d post dosing.

Statistics:

moving average method

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

10 244 mg/kg bw

95% CL:

>= 7 436 - <= 14 144

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

11 336 mg/kg bw

95% CL:

>= 9 339 - <= 13 822

Mortality:

- No. of deaths: not indicated.
- Time of death: 1 to 12 days after administration (males) and 3 to 11 days after administration (females)

Clinical signs:

other: Signs, which were few, included sluggishness, unsteady gait, emaciation and prostration, all of which developed by the end of the dosing period. Survivors usually recovered from these effects between 3 and 5 days after the start of dosing.

Gross pathology:

Necropsy of animals that died revealed dark red mottled lungs, dark red livers and mottled kidneys. Most survivors at necrospy did not reveal any gross pathology, but a few showed red mottled lungs and dark red livers.

Other findings:

erythema and oedema with ecchymosis, necrosis and ulceration was observed until the end of the observation period. During week 2 local desquamation, alopecia and scarring had developed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met