Registration Dossier

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: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Principles of method if other than guideline:
Method: other: dimethylamine was applied once for 24 hours to the clipped skin of the back and flank (area about 48 cm²) in a dose of 400, 2500, 3200, 4000 and 5000 mg/kg bw.
GLP compliance:
no
Test type:
other: no details given
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Dimethylamin, 40%-ige waessrige Loesung

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: WIga
- Weight at study initiation: male: 139 g (mean); female: 127 g (mean)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure:
- % coverage: 48 cm²

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h


Duration of exposure:
24 h
Doses:
400, 2500, 3200, 4000, 5000 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: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
3 900 mg/kg bw
Mortality:
5000 mg/kg: 6 animals died after 24 hours
4000 mg/kg: 6 animals died after 24 hours, 1 animal after 48 hours
3200 mg/kg: 1 animal died after 1 hour; 2 animals died after 24 hours
2500 mg/kg: 1 animal died after 24 hours
400 mg/kg: no mortality occured
Clinical signs:
apathy, convulsions, crying
Body weight:
no data
Gross pathology:
Animals that died:
Heart: acute dilatation, congestive hyperemia
Liver: peripheral lobule marking
Lung: oedema

Any other information on results incl. tables

400 mg/kg after 24 hours: primary irritation

2500 - 500 mg/kg after 24 hours: necrosis, which remained unchanched after 14 days

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
5000 mg/kg: 6 animals died after 24 hours
4000 mg/kg: 6 animals died after 24 hours, 1 animal after 48 hours
3200 mg/kg: 1 animal died after 1 hour; 2 animals died after 24 hours
2500 mg/kg: 1 animal died after 24 hours
400 mg/kg: no mortality occured
Executive summary:

In a study of BASF AG in 1980 rats were used for the occlusive administration of dimethylamine for a duration of 24 hours. The used concentrations were 400, 2500, 3200, 4000, and 5000 mg/kg bw. With the highest dosage 6 animals died after 24 hours, as well as with a dosage of 4000 mg/kg bw; whereby another animal died after 48 hours. By applicate dimethylamine in a concentration of 3200 mg/kg bw one animal died after 1 hour and two more animals after 24 hours. Just one animal died after 24 hours by the usage of 2500 mg/kg bw and no mortality occured by a dosage of 400 mg/kg bw. Apathy, convulsions, crying were the observed clinical symptons. In gross pathology acute dilation and congestive hyperemia of the heart was observed. The peripheral lobule of the liver was marked and oedema were observable in the lung.