Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 - 24 Feb 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. As a worst-case scenario, the skin was abraded and the dressing was occlusive.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
skin was abraded and the dressing was occlusive
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Dimethylamino-2-methyl-1-propanol, 73% DMAMP, Polymeen A (P-2614)
- Substance type: clear, pale yellow liquid
- Analytical purity: 72.03%
- Lot/batch No.: 730H18DF36
- pH: 12.5

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.7 ± 0.2 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: the animals' abdomen was shaved and the skin was abraded with a blunt hypodermic needle without causing bleeding, with the abrasions approximately 2-3 cm apart
- Type of wrap if used: the test substance was applied to the shaved skin area, which was covered with gauze and a sheet of impervious rubberized cloth. The trunk was enclosed in a flexible stainless steel protective screen held in place by tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test area was cleaned
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: no, volume adjusted according to weight of the rabbit
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
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 signs of toxicity daily, the body weight was recorded before dosing and on day 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: the treated skin area was examined regularly to assess the local irritating effects

In a range-finding study, one rabbit was exposed to 1000 mg/kg bw and one rabbit to 2000 mg/kg bw. As no mortality was observed, only 2000 mg/kg bw was used in the main study.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality during the study period.
Clinical signs:
No clinical signs were observed during the study period.
Body weight:
There were no effects on body weight.
Gross pathology:
The internal organs in all the rabbits were normal, except for the small intestines in some of the animals that showed adhesions. This is not considered to be a treatment-related effect as no dose-related effect was observed.
Other findings:
- Other observations: at the end of the 24 hours exposure period, the treated skin areas in all the rabbits were black in color. By day 7, the same skin areas were hard with eschar formation. At necropsy, the treated areas were necrotic at the abraded sites.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified