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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:
other: Acceptable publication which meets basic scientific principles.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): N-methyldiethanolamin

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals 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:
no data
Control animals:
not specified
Details on study design:
Test material was applied in occlusive contact for 24 h by gauze. Rabbits were examined for signs of toxic and for local skin effects at 7 and 14 d after removal of the occlusive dressing. Animals were weighted before dosing and at days 7 and 14 postdosing. All animals were subjected to gross necropsy examination.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
10 244 mg/kg bw
95% CL:
7 436 - 14 144
Sex:
female
Dose descriptor:
LD50
Effect level:
11 336 mg/kg bw
95% CL:
9 339 - 13 822
Mortality:
Time to death: males: 2 - 12 days; females: 3 - 11 days.
Clinical signs:
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 d after the start of dosing.
Body weight:
Animals lost weight during the first postdosing week, with partial recovery during the second week.

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.

Applicant's summary and conclusion