Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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: Acceptable, well-documented publication which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: 99%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Firma WIGA (Sulzfeld)
- Weight at study initiation: male animals 140g, female animals 130g
- all animals are healthy with unharmed skin

Administration / exposure

Type of coverage:
occlusive
Vehicle:
olive oil
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 cm2
- Type of wrap if used: aluminium foil fixed with stickytape

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water or water/lutrol mixture
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 200, 400 and 640 mg/kg
- Concentration: 25% and 50%
Duration of exposure:
24 h
Doses:
200, 400 and 640 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 21 days
- Frequency of observations and weighing: 1 h, 1, 2, 8 , 14 and 21 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
200 - 400 mg/kg bw
Based on:
test mat.
Mortality:
200 mg/kg; none of the animals died after 14 days
400 mg/kg; 3/5 males and 5/5 females after 21 days
640 mg/kg: all animals died after 24 h
Clinical signs:
Apathy, 24 hours after application necrosis was observed on all animals
Body weight:
Loss of body weight
Gross pathology:
Diseased animals
400-640 mg/kg: dilation and acute congestion hyperaemia of the heart, obvious almost infarctious bloody lungs
640 mg/kg: bright kidneys

Euthanized animals
No abnormal findings

Applicant's summary and conclusion

Executive summary:

In a dermal toxicity study, comparable to OECD 402, dipropylenetriamine was applied in olive oil occlusively at single doses of 200 to 640 mg/kg to Sprague-Dawley rats (5/sex/dose).

The LD50 falls between 200 and 400 mg/kg bw.