Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April to May 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well-documented, scientifically acceptable study report

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Principles of method if other than guideline:
according to BASF-internal standard
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Mean body weight: males 198 g, females 168 g
The animals were offered a standardized animal laboratory diet (Herilan MRH).

Administration / exposure

Type of coverage:
occlusive
Vehicle:
olive oil
Details on dermal exposure:
The test concentrations used were 15, 25, 45 and 50 % (G/G).
Application area: ca. 50 cm2
Application site: back
Duration of exposure:
24 hours
Doses:
100, 200, 400, 681 and 1000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical and local signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 300 mg/kg bw
Based on:
test mat.
Mortality:
100 mg/kg bw: no deaths after 14 days; 200 mg/kg bw: 3/6 after 14 days (only males died, starting after 7 days); 400 mg/kg bw: 2/6 after 14 days (1 male after 48 h and 1 female after 7 days); 681 and 1000 mg/kg bw: 6/6 after 14 days (starting after 24 h)
Clinical signs:
Dyspnea, apathy, excitation, staggering, twitching, spastic gait, flexion convulsions, biting convulsions, diarrhea, anemic paleness, exsiccosis, salivation, poor general state, ruffled fur, breathlessness, clotty eyes, leath deaths.
Body weight:
Initial body weight loss but later normal body weight development
Gross pathology:
Animals that died: heart: acute dilatation (right); liver: manifold slight brightened; kidneys; isolated yellow-white, radiate striation in the papilla region (papilla necrosis); animals manifold severe emaciated.
Sacrificed animals: kidneys: distinct papilla necrosis.
Other findings:
Local findings:
1000 mg/kg bw: After 24 hours questionable reddening, slight edema.
681 mg/kg bw: After 24 hours questionable reddening, slight edema.
400 mg/kg bw: After 24 hours questionable reddening, slight edema. After 7 days slight scaling (males only), otherwise without findings.
200 mg/kg bw: After 24 hours questionable reddening, slight edema; after 6 hours: slight scaling, very slight up to slight edema; after 14 days without findings.
100 mg/kg bw: After 24 hours questionable reddening, slight edema; after 7 days without findings.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category III
Remarks:
Migrated information
Conclusions:
The acute dermal LD 50 was around 300 mg(kg bw for male and female rats.
Executive summary:

The application of the test substance onto the back of female and male rats in doses of 100, 200, 400, 681 and 1000 mg/kg bw. Lead to deaths and different clinical signs in the animals. The acute dermal LD50 was determined to be around 300 mg/kg bw for male and female rats.