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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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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

Constituent 1
Chemical structure
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 levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
10 244 mg/kg bw
95% CL:
>= 7 436 - <= 14 144
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